Reset Your Expectations with Mounjaro1*
PEDS + ADULTS A1C Across Trials
PEDS + ADULTS Weight Across Trials
SURPASS-EARLY Phase 4 Trial ||| own-line
Discuss the data with a peer ||| own-line
In adults and in pediatric patients 10 years of age and older with type 2 diabetes1
Superior A1C reduction across 6 clinical trials1 | a1c-cross-trial
Data represent least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.1
aPediatric patients aged 10 to <18 years.1,2
bAt week 52, 26% of adult patients randomized to Tresiba achieved the fasting serum glucose target of <90 mg/dL, and the mean daily Tresiba dose was 49 U (0.5 U/kg).1
cAt week 52, 30% of adult 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).1
dp<0.001 for superiority vs comparator, adjusted for multiplicity.1
ep<0.05 for superiority vs Ozempic 1 mg, adjusted for multiplicity.1
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In adults and pediatric patients 10 years of age and older with T2D1
Superior effects on body weight* across 6 clinical trials1 | weight-across-trials
Mounjaro is not indicated for weight loss.
*In SURPASS-PEDS, percent change in BMI was a secondary endpoint. In SURPASS 1-5, change in weight was a secondary endpoint.1,2
Data are least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.1
aPediatric patients 10 to <18 years of age.1,2
bp<0.001 for superiority vs comparator, adjusted for multiplicity.1
cp<0.05 for superiority vs comparator, adjusted for multiplicity.1
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Common adverse reactions in placebo-controlled trials in adults1 | safety-profile
Adverse reactions in pool of placebo-controlled trials reported in ≥5% of Mounjaro-treated adult patients1
In the pool of placebo-controlled trials in adults, 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%).1
The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time.
Percentage of adult patients who discontinued treatment due to GI adverse reactions1
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Incidence of hypoglycemia with Mounjaro in placebo-controlled trials in adults1
Hypoglycemic Adverse Reactions in a Placebo-Controlled Monotherapy Trial, 40 Weeks1,a
Hypoglycemic Adverse Reactions in a Placebo-Controlled Trial As Add-on to Basal Insulin with or without Metformin Trial, 40 Weeks1,a
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.
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 patients treated with Mounjaro 5 mg, 10 mg, and 15 mg, respectively.1
GI=gastrointestinal.
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Explore Clinical Trial Data and New SURPASS-EARLY Study Data
In adults with T2D on metformin alone3
SURPASS-EARLY: Mounjaro vs Intensified Conventional Care (any other T2D medicine* alone or in combination)3 | surpass-early
Mounjaro 15 mg or MTD + Metformin vs ICC + Metformin3,4
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*,aExcluding tirzepatide.3
bMonthly follow-ups ending at week 24. The next follow-up was at week 32 (2 months). After week 32, patients had a follow-up every 3 months.3
The treatment goal for the ICC arm was to intensify treatment to reach glycemic control (within a non-diabetic range) safely according to local treatment guidelines. The treatment goal for the Mounjaro arm was to escalate treatment to Mounjaro 15 mg or MTD.3
Eligible patients had to be on a stable dose of metformin for at least 90 days before the screening period.3
Patients had a monthly follow-up for the first 6 months, followed by visits every 3 months starting at month 8 to evaluate progress. In the ICC arm, study investigators faced no cost or insurance restrictions when selecting T2D medications to prescribe. Guideline-recommended adjustments to therapy included escalation of doses and adding or switching T2D medications.3,4
A1C=glycated hemoglobin; DPP-4i=dipeptidyl peptidase-4 inhibitor; GLP-1 RA=glucagon-like peptide-1 receptor agonist; ICC=intensified conventional care; MTD=maximum tolerated dose; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes
In adults with T2D on metformin alone3
Common adverse events and incidence of hypoglycemia in patients taking Mounjaro 15 mg or MTD vs ICC through 104 weeks3
Common Adverse Events Occurring in ≥5% of Patients3
ICC=intensified conventional care; MTD=maximum tolerated dose; T2D=type 2 diabetes
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Incidence of Hypoglycemia3
aSevere hypoglycemia defined as episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.3
ICC=intensified conventional care; MTD=maximum tolerated dose; T2D=type 2 diabetes
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In adults with T2D on metformin alone3
Mean A1C and mean change in weight with Mounjaro 15 mg or MTD vs ICC from baseline to 104 weeks3
Mounjaro is not indicated for weight loss.
Change in weight was a key secondary endpoint.3
Primary endpoint: change in A1C from baseline to 104 weeks.3
Mean A1C Over Time From Baseline to 104 Weeks (%)3,4
Analysis based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy or prohibited medication) and may not represent a real-world setting. Post-baseline A1C data represent a model-based estimate derived from an MMRM model adjusting for baseline A1C, geographic region, age, and treatment-by-time interaction.3,4
aAnalysis based on treatment-regimen estimand data (in-trial efficacy regardless of treatment discontinuation or initiation of antihyperglycemic rescue or prohibited medication). n=398 for Mounjaro 15 mg or MTD; n=396 for ICC. Data represent a model-based estimate derived from an ANCOVA model adjusting for baseline A1C, treatment, geographic region, and age.3
Mean Change in Weight Over Time from Baseline to 104 Weeks (lb)3,4
Analysis based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy or prohibited medication) and may not represent a real-world setting.3 Post-baseline change in weight represents a model-based estimate derived from an MMRM model adjusting for baseline weight, geographic region, age, baseline A1C group, and treatment-by-time interaction.3,4
aAnalysis based on treatment-regimen estimand data (in-trial efficacy regardless of treatment discontinuation or initiation of antihyperglycemic rescue or prohibited medication). n=398 for Mounjaro 15 mg or MTD; n=396 for ICC. Data represent a model-based estimate derived from an ANCOVA model adjusting for baseline weight, treatment, baseline A1C group, geographic region, and age.3,4
A1C=glycated hemoglobin; ANCOVA=analysis of covariance; ICC=intensified conventional care; MMRM=mixed model for repeated measures; MTD=maximum tolerated dose; T2D=type 2 diabetes
In adults with T2D on metformin alone3
Composite endpoint with Mounjaro 15 mg or MTD vs ICC at 104 weeks3
Mounjaro is not indicated for weight loss.
Change in weight was a key secondary endpoint.3
Proportion of patients with3
aClinically significant hypoglycemia defined as blood glucose <54 mg/dL. Severe hypoglycemia defined as episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.3
Analysis based on treatment-regimen estimand data (in-trial efficacy regardless of treatment discontinuation or initiation of antihyperglycemic rescue or prohibited medication).3
Endpoint measures are from a logistic regression model using imputed data.3
A1C=glycated hemoglobin; CI=confidence interval; ICC=intensified conventional care; MTD=maximum tolerated dose; T2D=type 2 diabetes
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Study Designs | study-designs
Mounjaro vs placebo as an add-on to metformin and/or basal insulin1
- SURPASS-PEDS was a phase 3, double-blind, placebo-controlled trial that randomized (1:1:1) 99 pediatric patients 10 years of age and older with type 2 diabetes mellitus who had inadequate glycemic control on ≥1000 mg/day of metformin (69%), or basal insulin (8%), or both (23%) to receive SC Mounjaro 5 mg, Mounjaro 10 mg, or placebo once weekly as add-on therapy.1,2
- The primary objective was to demonstrate superiority of pooled Mounjaro (5 mg and 10 mg) to placebo in mean change from baseline in A1C at 30 weeks.2
- Key secondary objectives were assessed at 30 weeks for superiority of Mounjaro 5 mg and 10 mg individually vs. placebo: change from baseline in A1C, percentage of participants with A1C ≤6.5%, percent change in BMI.2
- Study participants were 10 to <18 years of age, had body weight ≥50 kg, BMI >85th percentile of the age- and sex-matched population, and had an A1C >6.5% to ≤11% at screening. Patients had a mean age of 14.7 years. The mean A1C was 8.0%, mean duration of T2D was 2.4 years, mean weight was 96.6 kg, and the mean baseline BMI was 35.4 kg/m2.1,2
- All patients in the Mounjaro treatment groups started on a dose of 2.5 mg once weekly, and the dose was escalated by 2.5 mg every 4 weeks until the target dose was reached. The 30-week double-blind period was followed by a 22-week open-label extension in which all participants received Mounjaro + metformin and/or basal insulin. In the open-label extension, participants in the placebo arm initiated Mounjaro 2.5 mg for 4 weeks and then continued on Mounjaro 5 mg for the remainder of the study (up to week 52).2
Mounjaro vs placebo ||| mt-3
- 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)1,5
- 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 weeks5
- 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 weight5
- Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years1,5
Mounjaro vs Ozempic (+ metformin) ||| mt-3
- 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® 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 study1,6
- 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 weeks6
- 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 for proportion of patients with A1C <5.7%6
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,6
Mounjaro vs Tresiba (+ metformin ± SGLT2i) ||| mt-3
- 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 100 U/mL (1:1:1:1 ratio)1,7
- 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.7
- 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 weeks7
- 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%7
- Study participants had a mean baseline A1C of 8.2% and a mean T2D duration of 8.4 years7
Mounjaro vs insulin glargine (+ 1-3 OAMs) ||| mt-3
- 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%)1,8
- 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)1,8
- 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 weeks8
- 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%8
- Study participants had a mean baseline A1C of 8.5% and a mean duration of T2D of 11.8 years1,8
Mounjaro vs placebo (+ insulin glargine ± metformin) ||| mt-3
- SURPASS-5 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 475 adult patients with 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)1,9
- 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, respectively1
- 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 weeks9
- 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 weight9
- Study participants had a mean baseline A1C of 8.3% and mean T2D duration of 13.3 years1,9
SURPASS-EARLY: Mounjaro 15 mg or MTD vs intensified conventional care (ICC)3||| mt-3
- SURPASS-EARLY was a randomized, open-label, parallel-group, phase 4 study to evaluate the long-term efficacy and safety of Mounjaro 15 mg or MTD + metformin compared with ICC + metformin in 794 adults diagnosed with type 2 diabetes within 0-4 years, whose blood glucose was inadequately controlled with diet and exercise and metformin (≥1500 mg/day or maximum tolerated dose for at least 90 days before baseline), alone. Metformin was to be continued as background therapy.3
- Participants in the ICC arm received ICC + metformin. ICC was defined as any glucose-lowering medication, tirzepatide excluded, used in clinical practice and supported by treatment guidelines, including intensified monitoring of usual care every 3 months with adjustments to therapy and additional monitoring as needed.3
- Participants in the Mounjaro arm received Mounjaro + metformin. Study medication was initiated at 2.5 mg and escalated every 4 weeks until 15 mg or MTD was reached.3
- The primary endpoint was change in A1C from baseline to week 104.3
- The key secondary endpoints were change in weight and change in waist circumference from baseline to week 104. Additional secondary endpoints included the proportion of participants who had the composite endpoint (A1C ≤6.5%, weight reduction ≥10%, and no clinically significant or severe hypoglycemia) at week 104, and change in insulin resistance from baseline to week 104.3
- Study participants were ≥18 years of age, were diagnosed with T2D 0-4 years before screening, had an A1C of ≥7% to ≤9.5%, and had a BMI of ≥25 kg/m2 to ≤45 kg/m2.3
- From randomization to week 104, the percentage of patients taking GLP-1 receptor agonists: semaglutide (injectable) (55.6%), semaglutide (oral) (18.2%), dulaglutide (11.8%). The percentage of patients taking SGLT2 inhibitors: empagliflozin (6.9%), dapagliflozin (6.1%), dapagliflozin propanediol monohydrate (2.6%), ertugliflozin (0.9%), and canagliflozin hemihydrate (0.3%). The percentage of patients taking sulfonylureas: gliclazide (2.0%) and glimepiride(1.2%). The percentage of patients taking DPP-4 inhibitors: linagliptin (0.9%),vildagliptin (0.6%), sitagliptin (0.3%), and sitagliptin phosphate (0.3%). The percentage of patients taking insulin: insulin glargine (2.0%) and insulin degludec(0.6%).4
- Mounjaro. Prescribing Information. Lilly USA, LLC
- Hannon TS, Chao LC, Barrientos-Pérez M, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025;406(10511)(Incl suppl mat):1484-1496. doi:10.1016/S0140-6736(25)01774-X
- Del Prato S, Heine RJ, Pérez Manghi FC, et al. Tirzepatide versus intensified conventional care after 2 years of treatment in early type 2 diabetes: a randomized clinical trial. Ann Intern Med. [Epub 26 May 2026]. doi:10.7326/ANNALS-25-05602
- Data on File. DOF-TR-US-0067. 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
- Frias JP, Davies MJ, Rosenstock J, et al; for the SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6)(suppl): 503-515. doi: 10.1056/NEJMoa2107519.
- Ludvik B, Giorgino F, 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:10.1016/50140-6736(21)01443-4
- Del Prato S, Kahn SE, Pavo |, 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:10.1016/50140-6736(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