Study S002157

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04657016
Acronym: SURMOUNT-3
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 579
Start: 2021-03-29
Primary completion: 2023-04-20
Lead sponsor: Eli Lilly and Company
Conditions: Obesity; Overweight
Interventions: DRUG:Tirzepatide; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHM

Registered primary outcomes

Percent Change From Baseline in Body Weight [Baseline, 72 Weeks]
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction [Week 72]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0007749	Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Wadden TA, Obesity (Silver Spring, Md.)	2026	Other trial	PMID 41537305 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:41537305
R0014849	Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Almandoz JP, Obesity pillars	2026	Randomized trial	PMID 41640675 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:41640675
R0015470	People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Li X, Obesity (Silver Spring, Md.)	2026	Other trial	PMID 41187013 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:41187013
R0016032	Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. Galindo RJ, JAMA network open	2026	Systematic review	PMID 41885866 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:41885866
R0016998	Achieving BMI <25 kg/m2 was associated with reduced predicted risk of atherosclerotic cardiovascular disease in people with obesity or overweight on tirzepatide or placebo: a post hoc analysis of SURMOUNT-1, -3, and -CN. Guo L, EClinicalMedicine	2026	Randomized trial	PMID 41536939 DOI	cites ClinicalTrials.gov:NCT04657016
R0016446	Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Gourgari E, Obesity (Silver Spring, Md.)	2025	Randomized trial	PMID 40717199 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:40717199
R0049852	1729-P: Achieving BMI <25 kg/m2 Was Associated with Reduced Predicted Risk of Atherosclerotic Cardiovascular Disease in People with Obesity or Overweight—A Post Hoc Analysis of SURMOUNT-1, -3, and -CN Lixin Guo, Diabetes	2025	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04657016
R0051793	1676-P: Tirzepatide Improved Mental and Psychosocial Function in Adults with Obesity or Overweight in the SURMOUNT-3 Trial Theresa M. Hunter, Diabetes	2024	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04657016
R0007405	Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden TA, Nature medicine	2023	Randomized trial	PMID 37840095 DOI	cites ClinicalTrials.gov:NCT04657016; registry reference DERIVED:37840095
R0008073	Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program. le Roux CW, Obesity (Silver Spring, Md.)	2023	Protocol	PMID 36478180 DOI	cites ClinicalTrials.gov:NCT04657016
R0047034	Tirzepatide maintained significant weight loss when treatment was continued in a follow‐up study ISKANDAR RAUF IDRIS, Diabetes Obesity and Metabolism Now	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04657016