Study S000093

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

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

Registration

Registration: NCT05822830
Acronym: SURMOUNT-5
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 751
Start: 2023-04-21
Primary completion: 2024-11-13
Lead sponsor: Eli Lilly and Company
Conditions: Obesity; Overweight
Interventions: DRUG:Tirzepatide; DRUG:Semaglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHJ; OTHER:U1111-1283-5404

Registered primary outcomes

Percent Change From Baseline in Body Weight [Baseline, Week 72]

Linked records (5)

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
R0008839	Tirzepatide compared with semaglutide in obesity disease: a subpopulation analysis applying Japan Society for the Study of Obesity criteria in the global SURMOUNT-5 trial. Kitamoto T, Current medical research and opinion	2026	Other trial	PMID 42434924 DOI	cites ClinicalTrials.gov:NCT05822830; registry reference DERIVED:42434924
R0009417	Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis. Aronne LJ, The American journal of medicine	2026	Other trial	PMID 41865857 DOI	cites ClinicalTrials.gov:NCT05822830; registry reference DERIVED:41865857
R0010113	Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: post-hoc analysis of the SURMOUNT-5 trial. Mamas MA, European heart journal open	2025	Randomized trial	PMID 40980721 DOI	cites ClinicalTrials.gov:NCT05822830; registry reference DERIVED:40980721
R0010879	Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. Aronne LJ, The New England journal of medicine	2025	Randomized trial	PMID 40353578 DOI	cites ClinicalTrials.gov:NCT05822830; registry reference DERIVED:40353578
R0016928	Weekly Journal Scan: long-term effects of tirzepatide for diabetes prevention in persons with obesity and prediabetes. Pedicino D, European heart journal	2025	Other trial	PMID 40249363 DOI	cites ClinicalTrials.gov:NCT05822830