Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07219966

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY3537031

Placebo

Study Details

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.

Conditions

Alcohol Use Disorder

Study ID

NCT07219966

Start date

Oct 15, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participant must be a minimum of 20 years of age for the investigative sites in Japan.
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
store and use the provided blinded study intervention, as directed
maintain electronic and paper study diaries, as applicable, and
complete the required questionnaires.

Exclusion Criteria:

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 either of the following:

history of advanced liver disease, including advanced liver fibrosis \[Stage 3\] or cirrhosis \[Stage 4\], based on prior biomarkers, imaging or liver biopsy, OR
history of acute alcohol-associated hepatitis based on prior liver biopsy.
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 Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY3537031 Period 1

Escalating doses administered subcutaneously (SC)

experimental: LY3537031 Period 2

Administered SC

placebo comparator: Placebo

Administered SC

Interventions

LY3537031

Administered SC

Placebo

Administered SC

Primary outcome measure

Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB) [ Time Frame: Up to 56 weeks ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Headlands Research - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85260

Principal Investigator:

Rosika McKinney

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

501-221-8681

Principal Investigator:

George Konis

UCLA Clinical & Translational Research Center (CTRC)

Recruiting

Los Angeles, California, United States, 90095

Contacts

310-794-5383

Principal Investigator:

Lara Ray

Artemis Institute for Clinical Research

Recruiting

San Diego, California, United States, 92123

Contacts

858-278-3647

Principal Investigator:

Eric Chavez

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

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Khaled Moussawi

Mountain Mind - Denver

Recruiting

Denver, Colorado, United States, 80202

Principal Investigator:

Larry Sanders

Accel Research Sites - Lakeland Clinical Research Unit

Recruiting

Lakeland, Florida, United States, 33803

Contacts

863-940-2087

Principal Investigator:

James Andersen

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Sejal Patel

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brandon Lenox

Life Arc Research Centers - Miami

Recruiting

Miami, Florida, United States, 33126

Principal Investigator:

Noel Garcia Acosta

Wellness Research Center

Recruiting

Miami, Florida, United States, 33135

Contacts

305-300-2623

Principal Investigator:

Emilio Mantero-Atienza

Life Medical Research Group Corp

Recruiting

Miami Gardens, Florida, United States, 33014

Contacts

305-705-4111

Principal Investigator:

Rafael Conte

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Jorel Martinez

K2 Medical Research - Tampa

Recruiting

Tampa, Florida, United States, 33634

Contacts

813-800-5252

Principal Investigator:

Kelley Wilson

Re:Cognition Health - Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Abid Nazeer

Maryland Treatment Centers - Mountain Manor Treatment Center

Recruiting

Baltimore, Maryland, United States, 21229

Principal Investigator:

Marc Fishman

Maryland Treatment Centers - Avery Road Treatment Center

Recruiting

Rockville, Maryland, United States, 20853

Principal Investigator:

Marc Fishman

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Principal Investigator:

Darin Dougherty

K2 Medical Research - Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

401-435-8950

Principal Investigator:

john stoukides

Adams Clinical Bronx

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Shama Farooq

North Star Medical Research

Recruiting

Middleburg Heights, Ohio, United States, 44130

Principal Investigator:

Mark Woyshville

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

215-746-1943

Principal Investigator:

Henry Kranzler

Avera Research Institute - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

605-504-3154

Principal Investigator:

Vivek Anand

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

214-645-6950

Principal Investigator:

Sherwood Brown

Adams Clinical Dallas

Recruiting

DeSoto, Texas, United States, 75115

Principal Investigator:

Benji Kurian

Pillar Clinical Research - Richardson

Recruiting

Richardson, Texas, United States, 75080

Contacts

214-396-4844

Principal Investigator:

Scott Bartley

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

Contacts

801-928-3292

Principal Investigator:

Michael Roundy

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Scott Williams

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Mark Duncan

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.