Study S000242

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)

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

Registration

Registration: NCT04660643
Acronym: SURMOUNT-4
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 783
Start: 2021-03-29
Primary completion: 2023-04-25
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-GPHN

Registered primary outcomes

Percent Change From Randomization in Body Weight at Week 88 [Randomization (Week 36), Week 88]

Linked records (10)

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
R0014495	Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial. Horn DB, JAMA internal medicine	2026	Randomized trial	PMID 41284285 DOI	cites ClinicalTrials.gov:NCT04660643; registry reference DERIVED:41284285
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:NCT04660643; 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:NCT04660643; 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:NCT04660643; registry reference DERIVED:41885866
R0015011	Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4. Gibble TH, Obesity (Silver Spring, Md.)	2025	Randomized trial	PMID 40903801 DOI	cites ClinicalTrials.gov:NCT04660643; registry reference DERIVED:40903801
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:NCT04660643; registry reference DERIVED:40717199
R0017458	Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials. Horn DB, Clinical obesity	2025	Randomized trial	PMID 39800653 DOI	cites ClinicalTrials.gov:NCT04660643; registry reference DERIVED:39800653
R0018941	Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. Aronne LJ, JAMA	2024	Randomized trial	PMID 38078870 DOI	cites ClinicalTrials.gov:NCT04660643; registry reference DERIVED:38078870
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:NCT04660643
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:NCT04660643