Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial - Video
Overview
SURMOUNT-5 was a 72-week, Phase 3b, multicenter, randomized, open-label, comparator-controlled study that evaluated the efficacy and safety of tirzepatide 15 mg or MTD (10 mg or 15 mg) compared with semaglutide 2.4 mg or MTD (1.7 mg or 2.4 mg) in adults with obesity or overweight with at least one obesity-related complication, excluding diabetes. All participants received lifestyle intervention with reduced-calorie diet and increased physical activity.
The primary endpoint was the mean percentage change in body weight from baseline to Week 72. Tirzepatide showed superior mean body weight reduction (-21.6%) compared to semaglutide (-15.4%). Key secondary endpoints included achieving ≥10%, ≥15%, ≥20%, and ≥25% weight reduction—1 in 3 patients on Tirzepatide MTD achieved ≥25% weight loss vs 1 in 5 with Semaglutide MTD.
Tirzepatide also led to greater reductions in waist circumference, systolic and diastolic Blood Pressure, triglycerides, and non-HDL cholesterol. The most common adverse events were gastrointestinal, mostly mild to moderate and were similar in both the arms.
Overall, tirzepatide demonstrated superior efficacy in weight and metabolic improvements compared to semaglutide in adults with obesity or overweight and comorbidities with similar safety profiles.
THERAPEUTIC INDICATION1:
Type 2 diabetes mellitus
MOUNJARO® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.
Weight management
MOUNJARO® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m² (obesity) or
• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus).
*SURMOUNT-5 was a 72-week, Phase 3b, multicenter, randomized, parallel-arm, open-label, comparator-controlled study that evaluated the efficacy and safety of Tirzepatide 15 mg or MTD (10 mg or 15 mg) compared with Semaglutide 2.4 mg or MTD (1.7 mg or 2.4 mg) in adults with Obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one Obesity-related complication (e.g., hypertension, dyslipidemia), excluding diabetes.** The study included a 2-week screening period. Mean baseline weight was 112.7 kg for Tirzepatide MTD (10 mg or 15 mg) and 113.4 kg for Semaglutide MTD (1.7 mg or 2.4 mg). Participants in both the Tirzepatide and Semaglutide treatment arms received lifestyle intervention, including a reduced-calorie diet and increased physical activity. Treatments were administered QW subcutaneously as an adjunct to a reduced-calorie diet and increased physical activity1.
For Tirzepatide Prescribing Information, please check: https://image.mc.lilly.com/lib/fe9312747462077971/m/1/0e04e051-5fa2-445b-850d-4f09ef66d35e.pdf
Efficacy estimand, mixed model for repeated measures (MMRM) analysis, modified intent-to-treat (mITT) population, (efficacy analysis set). Limitations of an open-label study may be related to a bias in evaluation of the outcomes, efficacy and/or safety, and analysis was not tested against a placebo-controlled comparison group1.
‡Limitations of an open-label study may be related to a bias in evaluation of the outcomes, efficacy and/or safety, and analysis was not tested against a placebo-controlled comparison group.1
SURMOUNT-1 Phase 3 double-blind, randomized, placebo-controlled trial in adults with Obesity (BMI of ≥30 kg/m²) or with Overweight (BMI of ≥27 kg/m²) with at least one Obesity-related complication (e.g.,hypertension, dyslipidemia), excluding T2D. All participants received lifestyle interventions, including a reduced-calorie diet and increased physical activity.** All patients were randomly assigned in a 1:1:1:1 ratio to receive placebo, or tirzepatide at a dose of 5 mg, 10 mg, or 15 mg as an adjunct to lifestyle intervention4
¶p<0.001 vs baseline. Mean % change in weight vs baseline (co-primary end point) at 72 weeks was -16.0% and -21.4% for the 5 mg and 10 mg doses, respectively. Mean % change in weight vs placebo at 72 weeks was -13.5%, -18.9%, and -20.1% for the 5 mg, 10 mg, and 15 mg doses, respectively (p<0.001 vs placebo, adjusted for multiplicity). Mean kg change in weight vs baseline at 72 weeks was -16.1 kg and -22.2 kg for the 5 mg and 10 mg doses, respectively. Mean kg change in weight vs placebo at 72 weeks was -13.8 kg, -19.8 kg, and -21.2 kg for the 5 mg, 10 mg, and 15 mg doses, respectively (p<0.001 vs placebo, not adjusted for multiplicity). 2,4
# Adverse reaction development was not an endpoint for this study. Data presented here should not be used to make inferences.
**”Obesity-related complications” are used as synonymic to “weight-related complications and /or comorbidities”.
REFERENCES
1. Louis J. Aronne, M.D., et al. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity, N Engl J Med. 2025; doi: 10.1056/NEJMoa2416394
2. Mounjaro® (tirzepatide), India Prescribing Information. Updated March 2025.
3. Fisman EZ, Tenenbaum A. Cardiovasc Diabetol. 2021;20(1):225.
4. Jastrebo_ AM, et al. N Engl J Med. 2022;387(3):205–16.
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PP-TR-IN-0580 | 29th July 2025
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