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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.

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 VoD SM-5 | 29th July 2025

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