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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT07219966

Run by

Eli Lilly and Company

People needed

1100

Starts

2025-10-15

Expected to finish

2028-04-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Headlands Research - Scottsdale — Scottsdale, Arizona, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• UCLA Clinical & Translational Research Center (CTRC) — Los Angeles, California, United States (enrolling)
• Artemis Institute for Clinical Research — San Diego, California, United States (enrolling)
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay — San Francisco, California, United States (enrolling)
• Mountain Mind - Denver — Denver, Colorado, United States (enrolling)
• Accel Research Sites - Lakeland Clinical Research Unit — Lakeland, Florida, United States (enrolling)
• K2 Medical Research - Maitland — Maitland, Florida, United States (enrolling)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (enrolling)
• Life Arc Research Centers - Miami — Miami, Florida, United States (enrolling)
• Wellness Research Center — Miami, Florida, United States (enrolling)
• Life Medical Research Group Corp — Miami Gardens, Florida, United States (enrolling)
• Charter Research - Orlando — Orlando, Florida, United States (enrolling)
• K2 Medical Research - Tampa — Tampa, Florida, United States (enrolling)
• Re:Cognition Health - Chicago — Chicago, Illinois, United States (enrolling)
• Maryland Treatment Centers - Mountain Manor Treatment Center — Baltimore, Maryland, United States (enrolling)
• Maryland Treatment Centers - Avery Road Treatment Center — Rockville, Maryland, United States (enrolling)
• Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
• K2 Medical Research - Foxborough — Foxborough, Massachusetts, United States (enrolling)
• Adams Clinical Bronx — The Bronx, New York, United States (enrolling)
• North Star Medical Research — Middleburg Heights, Ohio, United States (enrolling)
• Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States (enrolling)
• Avera Research Institute - Sioux Falls — Sioux Falls, South Dakota, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Adams Clinical Dallas — DeSoto, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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