Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-26 @ 6:47 AM
Study NCT ID:
NCT07219966
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENEW-ALC-1
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: