Reset Your Expectations with Mounjaro1*
Real-World Evidence ||| own-line
Discuss the data with a peer ||| own-line
SUPERIOR A1C reductions at every dose of Mounjaro when studied across a range of background therapies and comparators1† | a1c-cross-trial
Data represent least-squares mean from ANCOVA adjusted for baseline value and other stratification factors.
aAt week 52, 26% of 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
bAt 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).1
cp<0.001 for superiority vs comparator, adjusted for multiplicity.
dp<0.05 for superiority vs Ozempic 1 mg, adjusted for multiplicity.
*In other 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, 0.1% and 0.9% for placebo, 1.3% for Tresiba®, and 1.4% for insulin glargine.1
†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.1
ANCOVA=analysis of covariance; OAM=oral antihyperglycemic medication; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes.
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In adult patients with type 2 diabetes
Mounjaro demonstrated superior weight results across 5 clinical trials1 | weight-across-trials
Mounjaro is not indicated for weight loss.
Change in weight was secondary endpoint.
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.
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Common adverse reactions in placebo-controlled trials1 | safety-profile
Adverse reactions in pool of placebo-controlled trials reported in ≥5% of Mounjaro-treated patients1
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%).1
The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time.
Percentage of patients who discontinued treatment due to GI adverse reactions1
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Incidence of hypoglycemia with Mounjaro in placebo-controlled trials1
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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Common adverse events in a trial of Mounjaro vs Ozempic 1 mg2
Adverse events occurring in ≥5% of Mounjaro-treated patients2
Percentage of patients who discontinued treatment due to GI Adverse Events3
SURPASS-2 was not designed to evaluate the relative safety between Mounjaro and Ozempic 1 mg. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
GI=gastrointestinal.
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Incidence of Hypoglycemia in a Trial of Mounjaro vs Ozempic 1 mg2
aEpisodes requiring the assistance of another person to actively administer carbohydrate, glucose, or other resuscitative actions.
bOne patient had a hypoglycemic event that was not considered by the investigator to be severe, but it was reported as a serious adverse event.
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Significantly more patients achieved the ADA guideline-recommended A1C target of <7%*† with Mounjaro 10 mg and 15 mg1,4
The primary endpoint was mean change in A1C from baseline at 40 weeks.
IN ADULT PATIENTS WITH T2D ON METFORMIN
In adult patients with type 2 diabetes on metformin
*The ADA states that an A1C target of <7% (53 mmol/mol) is appropriate for many nonpregnant adults without significant hypoglycemia.4
†Key secondary endpoint controlled for type I error. Logistic regression adjusted for baseline value and other stratification factors.
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Percentage of patients with composite endpoint of A1C ≤6.5%, weight reduction ≥10%, and no clinically significant or severe hypoglycemia2,5* | composite-endpoint
Mounjaro is not indicated for weight loss.
aClinically 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.2
*In SURPASS-2, composite outcome was a prespecified secondary endpoint not controlled for type I error. Analysis based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy) and may not represent a real-world setting. The number of patients included in the efficacy analysis data set for Mounjaro 5 mg, 10 mg, 15 mg and Ozempic 1 mg were 470, 469, 469, and 468, respectively. Only participants with baseline value and at least one post-baseline value for the response variables were included in the analysis.5
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Percentage of patients with composite endpoint A1C <5.7%, weight reduction ≥10%, and no clinically significant or severe hypoglycemia5,6*
Mounjaro is not indicated for weight loss.
aClinically 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.6
*In SURPASS-2, the combination of A1C <5.7%, ≥10% weight loss, and no hypoglycemia was a post hoc analysis not controlled for type 1 error. Analysis based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy) and may not represent a real-world setting. The number of patients included in the efficacy analysis data set for Mounjaro 5 mg, 10 mg, 15 mg and Ozempic 1 mg were 461, 459, 464, and 461, respectively.5
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Explore Clinical Trial Results and Real-World Data for Mounjaro | real-world-evidence
Mounjaro real-world evidence: Mean changes in A1C and weight with Mounjaro and Ozempic® in adults with T2D7-9
Doses were pooled for Mounjaro up to 15 mg and for Ozempic up to 2 mg
Patients with No Evidence of Previous GLP-1 RA Use
Patients with Previous GLP-1 RA Use
Effectiveness should be interpreted in the context of the limitations of this retrospective, observational study
Mounjaro is not indicated for weight loss.
Data from real-world evidence (RWE) study. RWE differs from evidence derived from interventional clinical trials in terms of study design and methodology, patient population, treatment assignment, outcomes assessed, and source of data. RWE should be viewed as complementary to interventional clinical trial results.
Retrospective observational cohort study of adults with type 2 diabetes with commercial or Medicare Advantage (excluding Medicare Supplement Part D and California HMO) coverage initiating Mounjaro or Ozempic between May 13, 2022 and May 29, 2023 in the Healthcare Integrated Research Database (HIRD®). Patients were required to have six months of continuous medical and pharmacy benefit enrollment prior to and 12 months after initiation of Mounjaro or Ozempic. Patients were stratified according to prior use of oral or injectable GLP-1 RA in the 6 months prior to initiation of the index treatment (index). Doses of Mounjaro (2.5 mg to 15 mg) and Ozempic (0.25 mg to 2 mg) were pooled for analysis. Baseline characteristics were balanced using propensity score matching across cohorts. Patients with ≥1 valid A1C or weight value during the baseline and outcome assessment periods were included in the analyses of A1C and weight outcomes. Analyses were performed on the subgroup of patients with non-missing baseline and follow-up data.
A1C=glycated hemoglobin; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HMO=health maintenance organization; T2D=type 2 diabetes.
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Study Designs | study-designs
Mounjaro vs placebo
- 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)1,10
- 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 weeks10
- 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 weight10
- Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years1,10
Mounjaro vs Ozempic (+ metformin)
- 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 Ozempic ® 1 mg (1:1:1:1 ratio), all in combination with metformin ≥1500 mg per day1,2
- 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 weeks2
- 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%2
- Study participants had a mean baseline A1C of 8.3% and a mean T2D duration of 8.6 years1,12
Mounjaro vs Tresiba (+ metformin ± SGLT2i)
- 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)1,11
- 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.11
- 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 weeks11
- 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%11
- Study participants had a mean baseline A1C of 8.2% and a mean T2D duration of 8.4 years11
Mounjaro vs insulin glargine (+ 1-3 OAMs)
- 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%)1,12
- 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)1,12
- 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 weeks12
- 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%12
- Study participants had a mean baseline A1C of 8.5% and a mean duration of T2D of 11.8 years1,12
Mounjaro vs placebo (+ insulin glargine ± metformin)
- 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)1,13
- 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 weeks13
- 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 weight13
- Study participants had a mean baseline A1C of 8.3% and mean T2D duration of 13.3 years1,13
Real-World Use of Mounjaro and Ozempic®7-9 | real-world-evidence-sd
- Retrospective, observational, US cohort study of adults with commercial or Medicare Advantage (excluding Medicare Supplement Part D and California HMO) coverage with T2D initiating Mounjaro or Ozempic once weekly with or without prior use of GLP-1 RAs in the 6 months prior to index date (initiation of index treatment) in the Healthcare Integrated Research Database (HIRD®)
- Patients were ≥18 years of age on index date, had evidence of T2D diagnosis, had ≥1 pharmacy claim for Mounjaro or Ozempic from 13 May 2022 to 29 May 2023, had continuous enrollment during a 6-month pre-index and 12-month post-index period; and had no claims for other forms of diabetes during the 6-month pre-index period, no claims for bariatric or other procedures for obesity during the full pre-index period and 12-month post-index period, and had no claims for pregnancy, labor, and delivery in the 6-month pre index and 12-month post-index period
- Primary outcome was change in A1C and weight at 12 months of follow-up. Secondary outcomes were percent change in weight, proportion of patients with A1C ≤6.5%, proportion of patients with A1C <5.7%, cost per responder with A1C ≤6.5%, and proportion of patients adherent to medication at 12 months of follow-up
- Patients were stratified according to prior use of oral or injectable GLP-1 RAs in the 6-month pre-index period and then matched using propensity score adjustment. Patients were included in the analyses of A1C and weight if they had ≥1 valid A1C or weight value during the baseline and outcome assessment periods. Missing values were not imputed. Analyses were performed on patients with non-missing data. Doses of Mounjaro (2.5 mg to 15 mg) were pooled and doses of Ozempic (0.25 mg to 2 mg) were pooled for analysis. Changes in A1C and weight were assessed from baseline (90 days before to 14 days after index) to follow-up (index + 320 days to index + 410 days)
- At 12 months, for patients with no evidence of GLP-1 RA use in the prior 6 months, the use of Mounjaro for all eligible patients was 2.5 mg: 2%, 5 mg: 7%, 7.5 mg: 9%, 10 mg: 7%, 12.5 mg: 5%, 15 mg: 5%, and no fill: 66%, and the use of Ozempic for all eligible patients was 0.5 mg: 3%, 1 mg: 7%, 2 mg: 5%, and no fill: 84%
- At 12 months, for patients with previous GLP-1 RA use, the use of Mounjaro for all eligible patients was 2.5 mg: 1%, 5 mg: 5%, 7.5 mg: 8%, 10 mg: 8%, 12.5 mg: 6%, 15 mg: 6%, and no fill 66%, and the use of Ozempic for all eligible patients was 0.5 mg: 1%, 1 mg: 6%, 2 mg: 7%, and no fill: 86%
- Limitations when interpreting the results: propensity-score matching may not account for all potential confounders; this was a retrospective database analysis and not all confounding variables may have been collected in the database; administrative and pharmacy claims may not accurately reflect actual diagnoses and treatments; patients in the study were enrolled in commercial health insurance plans in the US and results may not be generalizable; requirement for continuous enrollment may result in selection bias; a small number of patients were excluded due to post-index events, which may bias results.
- Mounjaro. Prescribing Information. Lilly USA, LLC
- 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.
- Data on File. DOF-TR-US-0003. Lilly USA, LLC.
- American Diabetes Association. Professional Practice Committee. 6. Glycemic goals and hypoglycemia: Standards of care in diabetes—2024. Diabetes Care. 2024;47(suppl 1):S111-S125.
- Data on File. DOF-TR-US-0031. Lilly USA, LLC.
- Lingvay I, Cheng AY, Levine JA, et al. Achievement of glycaemic targets with weight loss and without hypoglycaemia in type 2 diabetes with the once-weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist tirzepatide: a post hoc analysis of the SURPASS 1 to - 5 studies. Diabetes Obes Metab. 2022;25(4):965-974. doi:10.1111/dom.14943
- Terrell K, Vallarino CR, Maldonado Lozada J, et al. Real-world effectiveness of tirzepatide vs. Semaglutide on HbA1c and weight in GLP-1 RA naive patients with naïve patients with T2D [abstract]. Value Health. 2025;28(Suppl 1):CO23.
- Data on File. DOF-TR-US-0054. Lilly USA, LLC.
- Hoog MM, Vallarino CR, Maldonado Lozada J, et al. Real-world effectiveness of tirzepatide vs. semaglutide on HbA1c and weight in GLP-1 RA experienced patients with T2D [abstract]. Value Health. 2025;29(Suppl 1):C072
- 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
- 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