SURMOUNT-5

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities

Lead sponsor

Eli Lilly and Company

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

751

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05822830

Org study ID17203

Secondary IDI8F-MC-GPHJEli Lilly and Company

Secondary IDU1111-1283-5404UTN Number

Timeline

Milestones

Study first posted2023-04-21actual

Study start2023-04-21actual

Primary completion2024-11-13actual

Study completion2024-11-13actual

Last update posted2025-11-26actual

Results first posted2025-11-26actual

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

18 endpoints

Primary/registry result

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
15 mg or MTD - Tirzepatide	-20.2	—
2.4 mg or MTD - Semaglutide	-13.7	—

LS Mean Difference-6.595% CI-8.1 – -4.9

Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
15 mg or MTD - Tirzepatide	87.7	—
2.4 mg or MTD - Semaglutide	66.7	—

Secondary/registry result

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
15 mg or MTD - Tirzepatide	71.7	—
2.4 mg or MTD - Semaglutide	45.0	—

Secondary/registry result

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
15 mg or MTD - Tirzepatide	55.0	—
2.4 mg or MTD - Semaglutide	31.1	—

Secondary/registry result

Percentage of Participants Who Achieve ≥25% Body Weight Reduction

Time frame:Week 72

≥25% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
15 mg or MTD - Tirzepatide	36.5	—
2.4 mg or MTD - Semaglutide	18.6	—

Secondary/registry result

Change From Baseline in Waist Circumference in Centimeter

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centimeters	95% CI
15 mg or MTD - Tirzepatide	-18.4	—
2.4 mg or MTD - Semaglutide	-13.0	—

LS Mean Difference-5.495% CI-7.1 – -3.6

Secondary/registry result

Percentage of Participants Who Achieve ≥30% Body Weight Reduction

Time frame:Week 72

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
15 mg or MTD - Tirzepatide	23.0	—
2.4 mg or MTD - Semaglutide	8.2	—

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per meter square	95% CI
15 mg or MTD - Tirzepatide	-8.5	—
2.4 mg or MTD - Semaglutide	-6.0	—

LS Mean Difference-2.695% CI-3.2 – -1.9

Secondary/registry result

Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
15 mg or MTD - Tirzepatide	-21.8	—
2.4 mg or MTD - Semaglutide	-15.4	—

LS Mean Difference-6.495% CI-8.0 – -4.7

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20% Body Weight Reduction

Time frame:Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥25% Body Weight Reduction

Time frame:Week 72

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference in Centimeter

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥30% Body Weight Reduction

Time frame:Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis.
The American journal of medicine2026 Mar 20PMID41865857doi:10.1016/j.amjmed.2026.03.010via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: post-hoc analysis of the SURMOUNT-5 trial.
European heart journal open2025 Sep (month)PMID40980721doi:10.1093/ehjopen/oeaf117via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.
The New England journal of medicine2025 Jul 3PMID40353578doi:10.1056/NEJMoa2416394via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.