NCT06584916

A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (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 orforglipron on maintenance of body weight reduction.

Detailed description

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2024-09-05
• Last updated: 2025-12-22

Locations

29 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study