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A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

Study acronym: RENEW-ALC-1
StatusRecruiting
PhasePhase 3
Started2025-10-15
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 18 times since 2025-10-21; most recent filed 2026-08-20. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-08-20
Amendment Study Status, Contacts/Locations v18
2026-08-05
Amendment Study Status, Contacts/Locations v17
2026-07-18
Amendment Study Status, Eligibility v16
2026-07-03
Amendment Study Status, Contacts/Locations v15
2026-06-19
Amendment Study Status, Contacts/Locations v14
2026-06-02
Amendment Study Status, Contacts/Locations v13
2026-05-20
Amendment Study Status, Contacts/Locations v12
2026-05-13
Amendment Study Status, Contacts/Locations v11
2026-04-16
Amendment Study Status, Contacts/Locations v10
2026-03-19
Amendment Study Status, Contacts/Locations v9
2026-03-05
Amendment Study Status, Contacts/Locations v8
2026-02-25
Amendment Study Status, Contacts/Locations v7
2026-02-09
Amendment Study Status, Contacts/Locations v6
2026-01-14
Amendment Study Status, Eligibility, Contacts/Locations v5
2026-01-09
Amendment Study Identification, Study Status, Contacts/Locations v4
2025-12-23
Amendment Study Status, Contacts/Locations v3
2025-12-03
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2025-11-10
Amendment Study Status, References v1
2025-10-21
Original filing
Trial Details
NCT Number NCT07219966
Lead Sponsor Eli Lilly and Company
Conditions Alcohol Use Disorder
Enrollment 1,100 participants
Start Date 2025-10-15
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-04