Indication: Mounjaro (tirzepatide) is indicated:

as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

Prescribing Information including Boxed Warning , Instructions for Use , and Medication Guide

Indications: Trulicity (dulaglutide) is indicated:

as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Prescribing Information including Boxed Warning , Instructions for Use , and Medication Guide

Escalation of Dulaglutide vs Switching to Tirzepatide in Adults With Type 2 Diabetes (SURPASS-SWITCH): An Open-label, Randomized, Phase 4 Trial

Phase 4 Study: Escalation vs. Switching Study Design

This study was a phase 4, open-label, active-controlled, parallel-group, multicenter, multinational, 40-week trial that randomized 282 adults with T2D who had inadequate glycemic control on Trulicity^® (dulaglutide) 0.75 mg or 1.5 mg and 0-3 OAMs (metformin, sulfonylurea, or SGLT2i) to escalate Trulicity to 4.5 mg or MTD or switch to Mounjaro with escalation to 15 mg or MTD.¹
Mounjaro was administered once weekly as an SC injection with a single-dose pen. The starting dose was 2.5 mg once weekly for 4 weeks, then increased in 2.5-mg increments every 4 weeks until 15 mg or the MTD was reached. Trulicity was administered once weekly as an SC injection with a single-dose pen. Trulicity was escalated every 4 weeks until 4.5 mg or MTD was reached.¹
The primary outcome was A1C change from baseline at 40 weeks.¹
The key secondary outcome was weight change from baseline at 40 weeks.¹

The open-label nature of this study may have resulted in reporting bias. The study duration and limited sample size precludes an assessment of longer-term end points.

Mounjaro^® and Trulicity^® and their delivery device bases are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Phase 4 Study: Escalation vs. Switching Study Design¹

Phase 4 Study: Escalation vs. Switching study design timeline — A graphic showing the study design for Phase 4 Study: Escalation vs. Switching. Phase 4 Study: Escalation vs. Switching was a 40-week trial that randomized patients to receive Mounjaro (15 mg or MTD) or to escalate Trulicity (4.5 mg or MTD) after a 3-week screening period. Mounjaro 2.5 mg was administered for 4 weeks, then increased in 2.5-mg increments every 4 weeks until 15 mg or MTD was reached. Trulicity was escalated every 4 weeks until 4.5 mg or MTD was reached. The primary endpoint was assessed at week 40. After the 40-week treatment period, there was a 4-week post-treatment follow-up.

A1C=glycated hemoglobin; MTD=maximum tolerated dose; OAM=oral antihyperglycemic medication; SC=subcutaneous; SGLT-2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

In adults with T2D

SURPASS-1 Study Design

SURPASS-1 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 478 adult patients with T2D who had inadequate glycemic control with diet and exercise to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg, or placebo (1:1:1:1 ratio)^2,3
The primary objective was to demonstrate superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to placebo in mean change from baseline in A1C at 40 weeks³
The key secondary objectives were assessed at 40 weeks: superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to placebo in proportion of patients with A1C <7% and <5.7%, mean change from baseline in fasting serum glucose, and mean change from baseline in weight³
Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years^2,3

SC=subcutaneous; T2D=type 2 diabetes.

SURPASS-1 study design: Mounjaro vs placebo monotherapy — A graphic showing the study design details of SURPASS-1 (Mounjaro vs placebo) from 3 weeks before the start of the study to week 40, followed by a 4-week safety follow-up period. Screening and lead-in began 3 weeks before the start of the study, and randomization occurred at week 0 (the start of the study). Patients randomized to receive all doses of Mounjaro started at 2.5 mg at week 0 and escalated to 5 mg at week 4. Patients randomized to Mounjaro 5 mg remained at that dose to week 40. Patients randomized to Mounjaro 10 mg escalated to 7.5 mg at week 8 and to 10 mg at week 12. They remained at that dose to week 40. Patients randomized to Mounjaro 15 mg escalated from 5 mg to 7.5 mg at week 8, to 10 mg at week 12, to 12.5 mg at week 16, and to 15 mg at week 20. They remained at that dose to week 40. Patients randomized to injectable placebo began receiving placebo at week 0 and received it to week 40.

QW=once weekly.

SURPASS-2 Study Design

SURPASS-2 was a 40-week, open-label (double-blind with respect to Mounjaro dose assignment), active-controlled, phase 3 trial that randomized 1879 adult patients with T2D who had inadequate glycemic control on stable doses of metformin alone to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15 mg or once-weekly SC injection Ozempic^® (semaglutide) 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day.
Ozempic 2 mg was not available at the time of the study.^2,4
The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Ozempic in mean change from baseline in A1C at 40 weeks⁴
The key secondary objectives were assessed at 40 weeks: noninferiority of Mounjaro 5 mg to Ozempic in mean change from baseline in A1C; superiority of Mounjaro to Ozempic in mean change from baseline in A1C; superiority of proportion of patients with A1C <7%; superiority in mean change from baseline in weight; superiority of Mounjaro 10 mg and/or 15 mg to Ozempic in proportion of patients with A1C <5.7%⁴
Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years^2,4

Ozempic^® is a registered trademark of Novo Nordisk A/S.

Ozempic 2 mg was not available at the time of the study.

QW=once weekly; SC=subcutaneous; T2D=type 2 diabetes

SURPASS-2 study design: Mounjaro vs Ozempic 1 mg as add-on to metformin — A graphic showing the study design details of SURPASS-2 (Mounjaro vs Ozempic 1 mg) from 3 weeks before the start of the study to week 40, followed by a 4-week safety follow-up period. Screening and lead-in began 3 weeks before the start of the study, and randomization occurred at week 0 (the start of the study). Patients randomized to receive all doses of Mounjaro (+ metformin) started at 2.5 mg at week 0 and escalated to 5 mg at week 4. Patients randomized to Mounjaro 5 mg remained at that dose to week 40. After starting at 2.5 mg then escalating to 5 mg, patients randomized to Mounjaro 10 mg escalated to 7.5 mg at week 8 and to 10 mg at week 12. They remained at that dose to week 40. Patients randomized to Mounjaro 15 mg escalated from 5 mg to 7.5 mg at week 8, to 10 mg at week 12, to 12.5 mg at week 16, and to 15 mg at week 20. They remained at that dose to week 40. Patients randomized to Ozempic 1 mg once weekly (+ metformin) started at 0.25 mg at week 0 and escalated to 0.5 mg at week 4 then to 1 mg at week 8. They remained at that dose to week 40.

SURPASS-3 Study Design

SURPASS-3 was a 52-week, open-label, active-controlled, phase 3 trial that randomized 1444 adult patients with T2D who had inadequate glycemic control on stable doses of metformin with or without an SGLT2i to once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or once-daily SC Tresiba^® (insulin degludec) 100 U/mL (1:1:1:1 ratio)^2,5
Tresiba was initiated at 10 U/day and titrated to a fasting blood glucose of <90 mg/dL using a treat-to-target algorithm. At week 52, the mean daily Tresiba dose was 49 U (0.5 U/kg), and 26% of patients achieved the target fasting serum glucose.²
The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to Tresiba in mean change from baseline in A1C at 52 weeks⁵
The key secondary objectives were assessed at 52 weeks: noninferiority of Mounjaro 5 mg to Tresiba in mean change from baseline in A1C and superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to Tresiba in mean change from baseline in A1C, mean change from baseline in weight, and proportion of patients with A1C <7%⁵
Study participants had a mean baseline A1C of 8.2% and a mean T2D duration of 8.4 years^2,5

Tresiba^® (insulin degludec) is a registered trademark of Novo Nordisk A/S.

SC=subcutaneous; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes

SURPASS-3 study design: Mounjaro vs Tresiba as add-on to metformin — A graphic showing the study design details of SURPASS-3 (Mounjaro vs Tresiba) (+ metformin ± SGLT2i) from 3 weeks before the start of the study to week 52, followed by a 4-week safety follow-up period. Screening and lead-in began 3 weeks before the start of the study, and randomization occurred at week 0 (the start of the study). Patients randomized to receive all doses of Mounjaro (+ metformin ± SGLT2i) started at 2.5 mg at week 0 and escalated to 5 mg at week 4. Patients randomized to Mounjaro 5 mg remained at that dose to week 52. After starting at 2.5 mg then escalating to 5 mg, patients randomized to Mounjaro 10 mg escalated to 7.5 mg at week 8 and to 10 mg at week 12. They remained at that dose to week 52. Patients randomized to Mounjaro 15 mg escalated from 5 mg to 7.5 mg at week 8, to 10 mg at week 12, to 12.5 mg at week 16, and to 15 mg at week 20. They remained at that dose to week 52. Patients randomized to titrated Tresiba once weekly (+ metformin ± SGLT2i) started with an initial insulin titration period at week 0 and began receiving stable and optimized Tresiba at week 16, and received it to week 52.

QD=once daily; QW=once weekly; SGLT2i=sodium-glucose co-transporter 2 inhibitor.

Mounjaro vs insulin glargine (+ 1-3 OAMs) Study Design

SURPASS 4 was a 104-week, open-label, active-controlled, phase 3 trial that randomized 2002 adult patients with T2D who had increased cardiovascular risk to once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or once-daily SC insulin glargine 100 U/mL (1:1:1:3 ratio), on background metformin (95%), and/or sulfonylureas (54%) and/or an SGLT2i (25%)^2,6
Insulin glargine was initiated at 10 U/day and titrated to a fasting blood glucose of <100 mg/dL using a treat-to-target algorithm; dose adjustments were made based on the median value of the last 3 self-monitored fasting blood glucose values. At week 52, 30% of patients achieved the target fasting serum glucose, and the mean daily insulin glargine dose was 44 U (0.5 U/kg).^2,6
The primary objective was to demonstrate noninferiority of Mounjaro 10 mg and/or 15 mg to insulin glargine in mean change from baseline in A1C at 52 weeks⁶
The key secondary objectives were assessed at 52 weeks: noninferiority of Mounjaro 5 mg to insulin glargine in mean change from baseline in A1C and superiority of Mounjaro 5 mg, 10 mg, and/or 15 mg to insulin glargine in mean change from baseline in A1C, mean change from baseline in weight, and proportion of patients with A1C <7%⁶
Study participants had a mean baseline A1C of 8.5% and a mean duration of T2D of 11.8 years^2,6

SURPASS-4 study design: Mounjaro vs insulin glargine as add-on to 1-3 oral antihyperglycemic medications — A graphic showing the study design details of SURPASS-4, Mounjaro vs insulin glargine (+ 1-3 OAMs), from 3 weeks before the start of the study to week 104, followed by a 4-week safety follow-up period. Screening and lead-in began 3 weeks before the start of the study, and randomization occurred at week 0 (the start of the study). Patients randomized to receive all doses of Mounjaro (+ 1-3 OAMs), started at 2.5 mg at week 0 and escalated to 5 mg at week 4. Patients randomized to Mounjaro 5 mg remained at that dose to week 104. After starting at 2.5 mg then escalating to 5 mg, patients randomized to Mounjaro 10 mg escalated to 7.5 mg at week 8 and to 10 mg at week 12. They remained at that dose to week 104. Patients randomized to Mounjaro 15 mg escalated from 5 mg to 7.5 mg at week 8, to 10 mg at week 12, to 12.5 mg at week 16, and to 15 mg at week 20. They remained at that dose to week 104. Patients randomized to titrated insulin glargine (+ 1-3 OAMs) started with an initial insulin titration period at week 0 and began receiving stable and optimized insulin glargine at week 16, and received it to week 104.

OAM=oral antihyperglycemic medication; QD=once daily; QW=once weekly; SC=subcutaneous; SGLT2i=sodium-glucose co-transporter 2 inhibitor; SU=sulfonylurea; T2D=type 2 diabetes.

In adults with T2D

SURPASS-5 Study Design

SURPASS-5 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 475 adult patients with Type 2 Diabetes (T2D) who had inadequate glycemic control on insulin glargine 100 U/mL, with or without metformin (≥1500 mg/day), to receive once-weekly SC Mounjaro 5 mg, 10 mg, 15 mg, or placebo (1:1:1:1 ratio)^2,7
The background dose of insulin glargine was titrated to a fasting blood glucose of <100 mg/dL using a treat-to-target algorithm. The mean starting dose of insulin glargine was 34 U/day, 32 U/day, 35 U/day, and 33 U/day for patients on Mounjaro 5 mg, 10 mg, 15 mg, and placebo, respectively. At randomization, the initial insulin glargine dose in patients with A1C ≤8.0% was reduced by 20%. At 40 weeks, the mean dose of insulin glargine was 38 U/day, 36 U/day, 29 U/day, and 59 U/day for patients on Mounjaro 5 mg, 10 mg, 15 mg, and placebo, respectively²
The primary objective was to demonstrate superiority of Mounjaro 10 mg and/or 15 mg to placebo in mean change from baseline in A1C at 40 weeks²
The key secondary objectives were assessed at 40 weeks: superiority of Mounjaro 5 mg to placebo in mean change from baseline in A1C, and superiority of Mounjaro to placebo in proportion of patients with A1C <7% (Mounjaro 5 mg, 10 mg, and 15 mg) and <5.7% (Mounjaro 10 mg and 15 mg), mean change from baseline in fasting serum glucose, and mean change from baseline in weight²
Study participants had a mean baseline A1C of 8.3% and mean T2D duration of 13.3 years²

SC=subcutaneous; QW=once weekly.

SUPERIOR A1C reductions at every dose of Mounjaro when studied across a range of background therapies and comparators²

SURPASS-1 through SURPASS-5: Reductions in A1C From Baseline (%)²

Reductions in A1C from baseline line graph comparing Mounjaro vs placebo and active comparators — Panel of 5 lollipop graphs showing the mean change in A1C at primary endpoint for adults with type 2 diabetes in the SURPASS 1-5 studies. The first graph shows Mounjaro vs placebo as monotherapy. From a mean baseline A1C of 8.0% (Mounjaro 5 mg, n=121), 7.9% (Mounjaro 10 mg, n=121), 7.9% (Mounjaro 15 mg, n=120), and 8.1% (placebo, n=113), mean change in A1C at 40 weeks was -1.8%, -1.7%, -1.7%, and -0.1%, respectively. The second graph shows Mounjaro vs once-weekly SC injection Ozempic^® (semaglutide) 1 mg as add-on to metformin. From a mean baseline A1C of 8.3% in all treatment arms (Mounjaro 5 mg, n=470; Mounjaro 10 mg, n=469; Mounjaro 15 mg, n=469; and Ozempic 1 mg, n=468), mean change in A1C at 40 weeks was -2.0%, -2.2%, -2.3%, and -1.9%, respectively. The third graph shows Mounjaro vs Tresiba^® (insulin degludec) as add-on to metformin with or without SGLT2i. From a mean baseline A1C of 8.2% in all Mounjaro treatment arms (Mounjaro 5 mg, n=358; Mounjaro 10 mg, n=360; Mounjaro 15 mg, n=358) and 8.1% for Tresiba (n=359), mean change in A1C at 52 weeks was -1.9%, -2.0%, -2.1%, and -1.3%, respectively. The fourth graph shows Mounjaro vs insulin glargine as add-on to 1-3 oral antihyperglycemic medications (metformin, SGLT2i, or sulfonylurea). From a mean baseline A1C of 8.5% (Mounjaro 5 mg, n=328), 8.6% (Mounjaro 10 mg, n=326), 8.5% (Mounjaro 15 mg, n=337), and 8.5% (insulin glargine, n=998), mean change in A1C at 52 weeks was -2.1%, -2.3%, -2.4%, and -1.4%, respectively. The fifth graph shows Mounjaro vs placebo as add-on to basal insulin with or without metformin. From a mean baseline A1C of 8.3% (Mounjaro 5 mg, n=116), 8.4% (Mounjaro 10 mg, n=118), 8.2% (Mounjaro 15 mg, n=118), and 8.4% (placebo, n=119), mean change in A1C at 40 weeks was -2.1%, -2.4%, -2.3%, and -0.9%, respectively.

*SURPASS study participants were adults on monotherapy, up to 3 orals, or basal insulin. They had a mean baseline A1C that ranged from 7.9% to 8.6%, and a mean duration of T2D that ranged from 4.7 to 13.3 years.²

Once-weekly SC injection Ozempic^® (semaglutide) 2 mg was not available at the time of the study.

Data represent least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.

¹At week 52, 26% of patients randomized to Tresiba^® (insulin degludec) achieved the fasting serum glucose target of <90mg/dL, and the mean daily Tresiba dose was 49 U (0.5U/kg).²

²At week 52, 30% of patients randomized to insulin glargine achieved the fasting serum glucose target of <100 mg/dL, and the mean daily insulin glargine dose was 44 U (0.5 U/kg).²

³p<0.001 for superiority vs comparator, adjusted for multiplicity.

⁴p<0.05 for superiority vs Ozempic 1 mg, adjusted for multiplicity.

Ozempic^® and Tresiba^® are registered trademarks of Novo Nordisk A/S.

ANCOVA=analysis of covariance; OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes; SC=sub-cutaneous.

See Change in A1C for Mounjaro vs Trulicity below

Select Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Mounjaro causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.

In adults with T2D

SURPASS-SWITCH:Changes from baseline in A1C at 40 weeks^1*†

Primary Endpoint – Change in A1C at 40 Weeks (%)¹

Primary Endpoint change in A1C at 40 weeks bar chart comparing Mounjaro vs Trulicity — Image of a bar graph that shows change in A1C for Mounjaro (n=139) and Trulicity (n=143) from a mean baseline A1C of 7.8%. Change in A1C was -1.4% for patients who switched to Mounjaro 15 mg or MTD and -0.7% for patients who escalated to Trulicity 4.5 mg or MTD. The estimated treatment difference was -0.8% with a 95% CI of -0.6% to -1.0%.

Mounjaro and Trulicity are not indicated for weight loss^2,8

Change in weight was a secondary endpoint.^1,3

Treatment-regimen estimand: ANCOVA analysis, mITT population.¹

Data presented are least-squares means.¹

*In other Mounjaro studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in A1C with Mounjaro ranged from 1.8% to 2.1% for the 5 mg dose, 1.7% to 2.4% for the 10 mg dose, and 1.7% to 2.4% for the 15 mg dose; and for comparators, mean change was 0.1% and 0.9% for placebo, 1.9% for Ozempic^® 1 mg, 1.3% for Tresiba^®, and 1.4% for insulin glargine.²

^†In other Mounjaro studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in body weight ranged from 12 lb to 17 lb for the 5 mg dose, 15 lb to 21 lb for the 10 mg dose, and 17 lb to 25 lb for the 15 mg dose; and for comparators, mean change was -2 lb and +4 lb for placebo, -13 lb for Ozempic^® 1 mg, +4 lb for Tresiba^®, and +4 lb for insulin glargine.²

This study only assessed switches from dulaglutide Trulicity and thus these findings should not be extrapolated to other GLP-1 RAs. This study did not assess the superiority of switching to Mounjaro versus switching to alternative antihyperglycemic medications.

Other product/company names mentioned herein are the trademarks of their respective owners.

T2D=type 2 diabetes; A1C=glycated hemoglobin; ANCOVA=analysis of covariance; CI=confidence interval; ETD=estimated treatment difference; mITT=modified intent-to-treat; MTD=maximum tolerated dose.

In adult patients with type 2 diabetes

Mounjaro demonstrated superior weight results across 5 clinical trials²

Mounjaro is not indicated for weight loss.

Change in weight was a secondary endpoint.

SURPASS-1 through SURPASS-5:Change in Weight From Baseline Across Doses (lb)²

SURPASS-1 through SURPASS-5 weight loss line graph comparing Mounjaro vs placebo and active comparators — Panel of 5 lollipop graphs showing the mean change in weight in the SURPASS 1-5 studies. The first graph shows Mounjaro vs placebo as monotherapy. From a mean baseline weight of 191.8 lb (Mounjaro 5 mg, n=121), 190.0 lb (Mounjaro 10 mg, n=121), 188.5 lb (Mounjaro 15 mg, n=120), and 186.3 lb (placebo, n=113), mean change in weight at 40 weeks was -14 lb, -15 lb, -17 lb, and -2 lb, respectively. The second graph shows Mounjaro vs Ozempic 1 mg as add-on to metformin. From a mean baseline weight of 203.9 lb (Mounjaro 5 mg, n=470), 209.0 lb (Mounjaro 10 mg, n=469), 206.8 lb (Mounjaro 15 mg, n=469), and 206.6 lb (Ozempic 1 mg, n=468), mean change in weight at 40 weeks was -17 lb, -21 lb, -25 lb, and -13 lb, respectively. The third graph shows Mounjaro vs Tresiba as add-on to metformin with or without SGLT2i. From a mean baseline weight of 208.1 lb (Mounjaro 5 mg, n=358); 206.8 lb (Mounjaro 10 mg, n=360); 209.2 lb (Mounjaro 15 mg, n=358), and 207.2 lb (Tresiba, n=359), mean change in weight at 52 weeks was -15 lb, -21 lb, -25 lb, and +4 lb, respectively. The fourth graph shows Mounjaro vs insulin glargine as add-on to 1-3 oral antihyperglycemic medications (metformin, SGLT2i, or sulfonylurea). From a mean baseline weight of 199.1 lb (Mounjaro 5 mg, n=328), 199.7 lb (Mounjaro 10 mg, n=326), 198.4 lb (Mounjaro 15 mg, n=337), and 198.9 lb (insulin glargine, n=998), mean change in weight at 52 weeks was -14 lb, -20 lb, -23 lb, and +4 lb, respectively. The fifth graph shows Mounjaro vs placebo as add-on to basal insulin with or without metformin. From a mean baseline weight of 211.2 lb (Mounjaro 5 mg, n=116), 208.6 lb (Mounjaro 10 mg, n=118), 211.6 lb (Mounjaro 15 mg, n=118), and 207.7 lb (placebo, n=119), mean change in weight at 40 weeks was -12 lb, -17 lb, -19 lb, and +4 lb, respectively.

Ozempic^® (semaglutide) and Tresiba^® (insulin degludec) are registered trademarks of Novo Nordisk A/S.

Ozempic 2 mg was not available at the time of the study.

Data are least-squares means from ANCOVA adjusted for baseline value and other stratiﬁcation factors.

^ap<0.001 for superiority vs comparator, adjusted for multiplicity.^bp<0.05 for superiority vs comparator, adjusted for multiplicity.

OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor.

In Adults with Type 2 Diabetes

Mounjaro^® (tirzepatide) change in weight from baseline at 40 weeks was -11% vs. -4% with Trulicity^® (dulaglutide).

Mounjaro and Trulicity are not indicated for weight loss.^2,8

Change in weight was a secondary endpoint.^2,8

Key Secondary Endpoint – Change in Weight at 40 Weeks (lb)^1,9

Key Secondary Endpoint change in weight at 40 weeks bar chart comparing Mounjaro vs Trulicity — Image of a bar graph that shows change in weight for Mounjaro (n=139) and Trulicity (n=143) from a mean baseline weight of 216.2 lb for the Mounjaro group and 211.6 lb for the Trulicity group. Change in weight was -21.7 lb (-11%) for patients who switched to Mounjaro 15 mg or MTD and -7.9 lb (-4%) for patients who escalated to Trulicity 4.5 mg or MTD. The estimated treatment difference was -13.8 lb with a 95% CI of -10.9 lb to -16.7 lb.

Treatment-regimen estimand: ANCOVA analysis, mITT population.¹

Data presented are least-squares means.¹

*In other Mounjaro studies of glycemic control with a primary endpoint at 40 weeks or 52 weeks, mean reductions in A1C with Mounjaro ranged from 1.8% to 2.1% for the 5 mg dose, 1.7% to 2.4% for the 10 mg dose, and 1.7% to 2.4% for the 15 mg dose; and for comparators, mean change was 0.1% and 0.9% for placebo, 1.9% for once-weekly SC injection Ozempic^® (semaglutide) 1 mg, 1.3% for Tresiba^® (insulin degludec), and 1.4% for insulin glargine.²

A1C=glycated hemoglobin; T2D=type 2 diabetes. ANCOVA=analysis of covariance; CI=confidence interval; ETD=estimated treatment difference; mITT=modified intent-to-treat; MTD=maximum tolerated dose.

Percentage of patients with a composite endpoint of A1C ≤6.5%, weight reduction of ≥10%, and no clinically significant or severe hypoglycemia at 40 weeks¹*

Mounjaro and Trulicity are not indicated for weight loss.^2,8

Change in weight was a secondary endpoint.^2,8

Additional Secondary Endpoint: Composite Endpoint Results at 40 Weeks (%)¹

Additional Secondary Endpoint composite results bar chart comparing Mounjaro vs Trulicity — Image of a bar graph that shows the composite endpoint results for patients taking Mounjaro 15 mg or MTD (n=139) or Trulicity 4.5 mg or MTD (n=143) at 40 weeks. 47.4% of patients who switched to Mounjaro 15 mg or MTD and 4.8% of patients who escalated to Trulicity 4.5 mg or MTD had the composite endpoint.

Logistic regression, mITT population (efficacy analysis set).¹

In Phase 4 Study: Escalation vs. Switching, composite outcome was a prespecified additional secondary endpoint.¹

*Clinically significant hypoglycemia defined as plasma glucose <54 mg/dL. Severe hypoglycemia defined as episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.¹

Study results should not be interpreted more broadly in consideration of the known cardiovascular benefits for Trulicity or other GLP-1 RAs versus the lack of proven cardiovascular benefits for Mounjaro. Providers should consider all the potential benefits and risks of all products when making treatment decisions.

A1C=glycated hemoglobin; T2D=type 2 diabetes. mITT=modified intent-to-treat; MTD=maximum tolerated dose.

Select Important Safety Information: Hypoglycemia Patients receiving Trulicity in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

In adults with T2D

Common adverse reactions in placebo-controlled trials²

This table shows common adverse reactions, excluding hypoglycemia, associated with the use of Mounjaro^® (tirzepatide) in the pool of phase 3 placebo-controlled trials in adults with Type 2 Diabetes (T2D). These adverse reactions occurred more commonly with Mounjaro than placebo and in at least 5% of patients treated with Mounjaro. Percentages reflect the number of patients who reported at least 1 treatment-emergent occurrence of the adverse reaction.

In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro than placebo (placebo 20.4%, Mounjaro 5 mg 37.1%, Mounjaro 10 mg 39.6%, Mounjaro 15 mg 43.6%).²

The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time.

Select Important Safety Information for Trulicity - Acute Kidney Injury due to Volume Depletion

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, including Trulicity. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Trulicity that could lead to volume depletion, especially during dosage initiation and escalation of Trulicity.

Select Important Safety Information for Trulicity - Severe Gastrointestinal Adverse Reactions

Use of Trulicity has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Trulicity (0.75 mg 2.2%, 1.5 mg 4.3%) than placebo (1.4%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Trulicity is not recommended in patients with severe gastroparesis.

Adverse Reactions in Pool of Placebo- Controlled Trials Reported in >5% of Mounjaro -Treated Adult Patients²

Adverse Reactions in Pool of Placebo-Controlled Trials Reported in >5% of Mounjaro-Treated Adult Patients
	MOUNJARO 5 mg (n=237) %	MOUNJARO 10 mg (n=240) %	MOUNJARO 15 mg (n=241) %	PLACEBO (n=235) %
Nausea	MOUNJARO 5 mg (n=237) %: 12	MOUNJARO 10 mg (n=240) %: 15	MOUNJARO 15 mg (n=241) %: 18	PLACEBO (n=235) %: 4
Diarrhea	MOUNJARO 5 mg (n=237) %: 12	MOUNJARO 10 mg (n=240) %: 13	MOUNJARO 15 mg (n=241) %: 17	PLACEBO (n=235) %: 9
Decreased appetite	MOUNJARO 5 mg (n=237) %: 5	MOUNJARO 10 mg (n=240) %: 10	MOUNJARO 15 mg (n=241) %: 11	PLACEBO (n=235) %: 1
Vomiting	MOUNJARO 5 mg (n=237) %: 5	MOUNJARO 10 mg (n=240) %: 5	MOUNJARO 15 mg (n=241) %: 9	PLACEBO (n=235) %: 2
Constipation	MOUNJARO 5 mg (n=237) %: 6	MOUNJARO 10 mg (n=240) %: 6	MOUNJARO 15 mg (n=241) %: 7	PLACEBO (n=235) %: 1
Dyspepsia	MOUNJARO 5 mg (n=237) %: 8	MOUNJARO 10 mg (n=240) %: 8	MOUNJARO 15 mg (n=241) %: 5	PLACEBO (n=235) %: 3
Abdominal pain	MOUNJARO 5 mg (n=237) %: 6	MOUNJARO 10 mg (n=240) %: 5	MOUNJARO 15 mg (n=241) %: 5	PLACEBO (n=235) %: 4

Incidence of hypoglycemia with Mounjaro in placebo-controlled trials²

Hypoglycemia was more frequent when Mounjaro was used in combination with a sulfonylurea. In a clinical trial up to 104 weeks of treatment, when administered with a sulfonylurea, severe hypoglycemia occurred in 0.5%, 0%, and 0.6%, and hypoglycemia (glucose level <54 mg/dL) occurred in 13.8%, 9.9%, and 12.8% of adult patients treated with Mounjaro 5 mg, 10 mg, and 15 mg, respectively.²

Hypoglycemic Adverse Reactions in a Placebo-Controlled Monotherapy Trial in Adults with T2D²

Hypoglycemic Adverse Reactions in a Placebo-Controlled Monotherapy Trial in Adults with T2D
	MOUNJARO 5 mg	MOUNJARO 10 mg	MOUNJARO 15 mg	PLACEBO
Monotherapy	MOUNJARO 5 mg:	MOUNJARO 10 mg:	MOUNJARO 15 mg:	PLACEBO:
40 weeksᵃ	MOUNJARO 5 mg: n=121	MOUNJARO 10 mg: n=119	MOUNJARO 15 mg: n=120	PLACEBO: n=115
Severe hypoglycemiaᵇ (%)	MOUNJARO 5 mg: 0	MOUNJARO 10 mg: 0	MOUNJARO 15 mg: 0	PLACEBO: 0
Blood glucose level <54 mg/dL (%)	MOUNJARO 5 mg: 0	MOUNJARO 10 mg: 0	MOUNJARO 15 mg: 0	PLACEBO: 1

Hypoglycemic Adverse Reactions in a Placebo-Controlled Trial As Add-on to Basal Insulin with or without Metformin in Adults with T2D¹

Hypoglycemic Adverse Reactions in a Placebo-Controlled Trial As Add-on to Basal Insulin with or without Metformin in Adults with T2D¹
	MOUNJARO 5 mg	MOUNJARO 10 mg	MOUNJARO 15 mg	PLACEBO
Add-on to basal insulin with or without metformin	MOUNJARO 5 mg:	MOUNJARO 10 mg:	MOUNJARO 15 mg:	PLACEBO:
40 weeksᵃ	MOUNJARO 5 mg: n=116	MOUNJARO 10 mg: n=119	MOUNJARO 15 mg: n=120	PLACEBO: n=120
Severe hypoglycemiaᵇ (%)	MOUNJARO 5 mg: 0	MOUNJARO 10 mg: 2	MOUNJARO 15 mg: 1	PLACEBO: 0
Blood glucose level <54 mg/dL (%)	MOUNJARO 5 mg: 16	MOUNJARO 10 mg: 19	MOUNJARO 15 mg: 14	PLACEBO: 13

^aReflects the study treatment period. Data include events occurring during 4 weeks of treatment-free safety follow-up. Events after introduction of a new glucose-lowering treatment are excluded.

^bEpisodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

T2D = type 2 diabetes

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References

Billings LK, Winne L, Sharma P, Gomez-Valderas E, Chivukula KK, Kwan AYM. Comparison of dose escalation versus switching to tirzepatide among people with type 2 diabetes inadequately controlled on lower doses of dulaglutide: a randomized clinical trial. Ann Intern Med. 2025;Epub(incl suppl mat + protocol). doi: 10.7326/ANNALS-24-03849
Mounjaro. Prescribing Information. Lilly USA, LLC.
Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. doi:10.1016/S0140-6736(21)01324-6
Frías JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6)
(Incl Suppl Append):503-515. doi:10.1056/NEJMoa2107519
Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4
Del Prato S, Kahn SE, Pavo I, et al; for the SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7
Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. doi: 10.1001/jama.2022.0078
Trulicity. Prescribing Information. Lilly USA, LLC.
Data on File. DOF-TR-US-0057. Lilly USA, LLC.

IMPORTANT SAFETY INFORMATION FOR MOUNJARO^® (TIRZEPATIDE)

WARNING: RISK OF THYROID C-CELL TUMORS

Contraindications: Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Mounjaro.

Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or Mounjaro. Observe patients for signs and symptoms, including persistent or severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported in patients treated with Mounjaro. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.

Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or Mounjaro. The majority of reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Mounjaro that could lead to volume depletion, especially during dosage initiation and escalation of Mounjaro.

Severe Gastrointestinal Adverse Reactions: Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials in adults, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Mounjaro is not recommended in patients with severe gastroparesis.

Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Acute Gallbladder Disease: In placebo-controlled clinical trials in adults, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

Pulmonary Aspiration During General Anesthesia or Deep Sedation: Mounjaro delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Mounjaro.

Adverse Reactions in Adults: The most common adverse reactions reported in ≥5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. In a cardiovascular outcomes trial of 6,647 adults with type 2 diabetes and established cardiovascular disease exposed to Mounjaro, adverse reactions reported with Mounjaro were similar with the exception of dysesthesia (0.7%), decreased appetite (17%), constipation (13%), vomiting (12%), abdominal pain (10%), and fatigue (10%).

Drug Interactions: When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Pregnancy: Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation: In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose. There are no available data on the effects of tirzepatide on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.

Females of Reproductive Potential: Advise females using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.

Pediatric Use: Adverse reactions reported in pediatric patients 10 years of age and older treated with Mounjaro were similar to those reported in adults with the exception of a higher incidence of vomiting, abdominal pain, and hypoglycemia. The safety and effectiveness of Mounjaro have not been established and use is not recommended in patients less than 10 years of age.

Dosage Forms and Strengths: Mounjaro is available as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL subcutaneous injection in a prefilled single-dose pen.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.

Please see Instructions for Use included with the pen.

TR HCP ISI AUG2026

IMPORTANT SAFETY INFORMATION FOR TRULICITY^® (DULAGLUTIDE)

WARNING: RISK OF THYROID C-CELL TUMORS

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Contraindications: Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: One case of MTC was reported in a patient treated with Trulicity in a clinical trial. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND). If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Acute pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including Trulicity. Observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue Trulicity and initiate appropriate management.

Hypoglycemia: Patients receiving Trulicity in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Trulicity is contraindicated in patients with a previous serious hypersensitivity reaction to dulaglutide or to any of the components of Trulicity. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity.

Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 RAs, including Trulicity. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Trulicity that could lead to volume depletion, especially during dosage initiation and escalation of Trulicity.

Severe Gastrointestinal Adverse Reactions: Use of Trulicity has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Trulicity (0.75 mg 2.2%, 1.5 mg 4.3%) than placebo (1.4%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Trulicity is not recommended in patients with severe gastroparesis.

Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in Trulicity-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy. Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on Trulicity and placebo respectively. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Pulmonary Aspiration During General Anesthesia or Deep Sedation: Trulicity delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Trulicity.

Most common adverse reactions: Incidence reported in ≥5% of Trulicity-treated patients in trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia, and fatigue.

Oral Medications and Delayed Gastric Emptying: Trulicity slows gastric emptying, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: Limited data with Trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.

Pediatric Use: Trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to Trulicity-treated adults. Safety and effectiveness of Trulicity have not been established in patients less than 10 years of age.

Dosage Forms and Strengths: Trulicity is available as a 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg per 0.5 mL subcutaneous injection in a prefilled single-dose pen.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.

Please see Instructions for Use included with the pen.

DG HCP ISI 25MAR2026

Escalation of Dulaglutide vs Switching to Tirzepatide in Adults With Type 2 Diabetes (SURPASS-SWITCH): An Open-label, Randomized, Phase 4 Trial

Phase 4 Study: Escalation vs. Switching Study Design

Phase 4 Study: Escalation vs. Switching Study Design1

SURPASS-1 Study Design

SURPASS-2 Study Design

SURPASS-3 Study Design

Mounjaro vs insulin glargine (+ 1-3 OAMs) Study Design

SURPASS-5 Study Design

SUPERIOR A1C reductions at every dose of Mounjaro when studied across a range of background therapies and comparators2

SURPASS-1 through SURPASS-5: Reductions in A1C From Baseline (%)2

Select Important Safety Information

SURPASS-SWITCH:Changes from baseline in A1C at 40 weeks1*†

Primary Endpoint – Change in A1C at 40 Weeks (%)1

Mounjaro demonstrated superior weight results across 5 clinical trials2

SURPASS-1 through SURPASS-5:Change in Weight From Baseline Across Doses (lb)2

Mounjaro® (tirzepatide) change in weight from baseline at 40 weeks was -11% vs. -4% with Trulicity® (dulaglutide).

Key Secondary Endpoint – Change in Weight at 40 Weeks (lb)1,9

Percentage of patients with a composite endpoint of A1C ≤6.5%, weight reduction of ≥10%, and no clinically significant or severe hypoglycemia at 40 weeks1*

Additional Secondary Endpoint: Composite Endpoint Results at 40 Weeks (%)1

Common adverse reactions in placebo-controlled trials2

Adverse Reactions in Pool of Placebo- Controlled Trials Reported in >5% of Mounjaro -Treated Adult Patients2

Incidence of hypoglycemia with Mounjaro in placebo-controlled trials2

Hypoglycemic Adverse Reactions in a Placebo-Controlled Monotherapy Trial in Adults with T2D2

Hypoglycemic Adverse Reactions in a Placebo-Controlled Trial As Add-on to Basal Insulin with or without Metformin in Adults with T2D1

References

Phase 4 Study: Escalation vs. Switching Study Design¹

SUPERIOR A1C reductions at every dose of Mounjaro when studied across a range of background therapies and comparators²

SURPASS-1 through SURPASS-5: Reductions in A1C From Baseline (%)²

SURPASS-SWITCH:Changes from baseline in A1C at 40 weeks^1*†

Primary Endpoint – Change in A1C at 40 Weeks (%)¹

Mounjaro demonstrated superior weight results across 5 clinical trials²

SURPASS-1 through SURPASS-5:Change in Weight From Baseline Across Doses (lb)²

Mounjaro^® (tirzepatide) change in weight from baseline at 40 weeks was -11% vs. -4% with Trulicity^® (dulaglutide).

Key Secondary Endpoint – Change in Weight at 40 Weeks (lb)^1,9

Percentage of patients with a composite endpoint of A1C ≤6.5%, weight reduction of ≥10%, and no clinically significant or severe hypoglycemia at 40 weeks¹*

Additional Secondary Endpoint: Composite Endpoint Results at 40 Weeks (%)¹

Common adverse reactions in placebo-controlled trials²

Adverse Reactions in Pool of Placebo- Controlled Trials Reported in >5% of Mounjaro -Treated Adult Patients²

Incidence of hypoglycemia with Mounjaro in placebo-controlled trials²

Hypoglycemic Adverse Reactions in a Placebo-Controlled Monotherapy Trial in Adults with T2D²

Hypoglycemic Adverse Reactions in a Placebo-Controlled Trial As Add-on to Basal Insulin with or without Metformin in Adults with T2D¹