Trials / Recruiting
RecruitingNCT07219966
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,100 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LY3537031 | Administered SC |
| DRUG | Placebo | Administered SC |
Timeline
- Start date
- 2025-10-15
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2025-10-22
- Last updated
- 2026-04-17
Locations
119 sites across 8 countries: United States, Belgium, China, Germany, Japan, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07219966. Inclusion in this directory is not an endorsement.