Phase 3
Completed N=751
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Source: ClinicalTrials.gov NCT05822830 ↗Enrolled (actual)
751
Serious AEs
4.1%
Results posted
Nov 2025
Primary outcomePrimary: Percent Change From Baseline in Body Weight — -20.2; -13.7 Percent change
◆ Published Evidence
Highly cited
419citations · ~419 / year
Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.
Summary
The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
Linked Publications (3)
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Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.
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Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: <i>post-hoc</i> analysis of the SURMOUNT-5 trial.
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Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight |
-20.2; -13.7 | — |
| SECONDARY Percentage of Participants Who Achieve ≥10% Body Weight Reduction |
87.7; 66.7 | — |
| SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction |
71.7; 45.0 | — |
| SECONDARY Percentage of Participants Who Achieve ≥20% Body Weight Reduction |
55.0; 31.1 | — |
| SECONDARY Percentage of Participants Who Achieve ≥25% Body Weight Reduction |
36.5; 18.6 | — |
| SECONDARY Change From Baseline in Waist Circumference in Centimeter |
-18.4; -13.0 | — |
| SECONDARY Percentage of Participants Who Achieve ≥30% Body Weight Reduction |
23.0; 8.2 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-8.5; -6.0 | — |
| SECONDARY Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide |
-21.8; -15.4 | — |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 unsuccessful dietary effort to lose body weight
Exclusion Criteria
- Diabetes mellitus
- Change in body weight greater than 5 kg within 3 months prior to starting study
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Data sourced from ClinicalTrials.gov (NCT05822830) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.