Recruiting

RENEW-ALC-2Brenipatide for Alcohol Use Disorder Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LY3537031

+ Placebo

Drug
Who is being recruted

Alcoholism+2

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 19, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: October 16, 2025

Actual 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) 
NCT07219953
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 19, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

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 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).
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.

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 125 locations

Recruiting

Parkway Medical Center

Birmingham, United StatesSee the location
Recruiting

Headlands Research - Scottsdale

Scottsdale, United States
Recruiting

Artemis Institute for Clinical Research

San Diego, United States
Recruiting

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay

San Francisco, United States
Recruiting
125 Study Centers