Recruiting soon
RENEW-ALC-2

Brenipatide for Alcohol Use Disorder Treatment

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What is being tested

LY3537031

+ Placebo
Drug
Who is being recruted

Alcohol Use Disorder

From 18 to 75 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual date on which the first participant was enrolled.

The study is focused on understanding if a medication called brenipatide is effective and safe for adults dealing with Alcohol Use Disorder (AUD) and engaging in hazardous drinking behaviors. This condition can significantly affect individuals' health and daily life, and finding a reliable treatment could greatly improve their quality of life and reduce the risks associated with excessive alcohol use. The study aims to compare brenipatide to a placebo, which is a substance with no active drug, to determine whether it successfully helps reduce harmful drinking habits. Participants in this study will be involved for about 56 weeks. During this time, they will receive either the brenipatide medication or a placebo, although neither the participants nor the researchers will know who is receiving which treatment, ensuring unbiased results. The study will closely monitor the participants to evaluate the effectiveness of brenipatide in reducing alcohol consumption and to assess any potential side effects. The goal is to gather clear evidence on whether brenipatide can be a safe and effective option for treating AUD.

Official TitleA 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 Alcohol Use Disorder (RENEW-ALC-2) 
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: November 4, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alcohol Use Disorder
Criteria
2 inclusion criteria required to participate
Are seeking treatment and are motivated to stop or cut down on drinking.
Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention. * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires.
4 exclusion criteria prevent from participating
Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.
Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.
Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Escalating doses administered subcutaneously (SC)
Group II
Experimental
Administered SC
Group III
Placebo
Administered SC
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 124 locations
Suspended
Parkway Medical CenterBirmingham, United StatesSee the location
Suspended
Headlands Research - ScottsdaleScottsdale, United States
Suspended
UCLA Clinical & Translational Research Center (CTRC)Los Angeles, United States
Suspended
Artemis Institute for Clinical ResearchSan Diego, United States
Recruiting soon124 Study Centers