NCT05869903

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,127 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Conditions

• Obesity
• Overweight
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-07-25
• Completion: 2027-10-01
• First posted: 2023-05-22
• Last updated: 2025-11-05

Locations

138 sites across 10 countries: United States, Brazil, China, India, Japan, Puerto Rico, Slovakia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study