Study S001952

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)

ClinicalTrials.gov record

Registration

Registration: NCT06047548
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 441
Start: 2023-09-20
Primary completion: 2026-01-20
Lead sponsor: Eli Lilly and Company
Conditions: Overweight; Obesity
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPIQ

Registered primary outcomes

Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period [Week 112]

Linked records (2)

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
R0013285	Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial. Horn DB, Lancet (London, England)	2026	Randomized trial	PMID 42119587 DOI	cites ClinicalTrials.gov:NCT06047548; registry reference DERIVED:42119587
R0015500	Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN. Horn DB, Obesity (Silver Spring, Md.)	2025	Protocol	PMID 40916045 DOI	cites ClinicalTrials.gov:NCT06047548; registry reference DERIVED:40916045