NCT06047548

A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.

Detailed description

All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-01-20
• Completion: 2026-01-20
• First posted: 2023-09-21
• Last updated: 2026-03-25

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study