2025-522313-38-00
Not yet recruiting
Phase 3
J2S-MC-GZME: 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)
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Eli Lilly & Co.
- Enrollment
- 47
- Locations
- 5
- Primary Endpoint
- Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Overview
Brief Summary
Period 1 Primary Objective To demonstrate that at least 1 dose level of brenipatide is superior to placebo for at least 1 of the dual primary endpoints
Period 2 Primary Objective For brenipatide responders from Period 1: To evaluate the ability of brenipatide (pooled across doses) to maintain a general reduction in alcohol consumption endpoint
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Motivated to stop or cut down on drinking.
- •Willing to take part in the whole study and go to all the needed visits
- •Willing to do what the study asks, like giving yourself the medicine, keeping and using the medicine as told, writing in study diaries, and answering questions.
Exclusion Criteria
- •Used or currently use illegal drugs or medicines that were not prescribed to you in the past 180 days. This does not include alcohol, nicotine, or caffeine.
- •Had serious liver problems in the past, like bad liver scarring (fibrosis or cirrhosis) or liver disease caused by alcohol, based on past liver tests or scans (like ultrasound, CT, MRI, or special blood tests).
Outcomes
Primary Outcomes
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)
Secondary Outcomes
No secondary outcomes reported
Investigators
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
Study Sites (5)
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