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Clinical Trials in the USA / NCT07219953
Recruiting Phase 3

A Study of Brenipatide in Participants With Alcohol Use Disorder

NCT07219953 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-10-16
Last updated
2026-08-21

Condition(s) studied

Alcohol Use Disorder

Investigational drug(s) / intervention(s)

LY3537031Placebo

LY3537031: Administered SC

Placebo: Administered SC

Study summary

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 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. 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 or 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).

Primary outcome measure(s)

Trial sites (116)

FacilityCityRegionStatus
Headlands Research - Scottsdale Scottsdale Arizona Recruiting
Woodland International Research Group Little Rock Arkansas Recruiting
UCLA Clinical & Translational Research Center (CTRC) Los Angeles California Recruiting
Artemis Institute for Clinical Research Riverside California Recruiting
Artemis Institute for Clinical Research San Diego California Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay San Francisco California Recruiting
Accel Research Sites - Lakeland Clinical Research Unit Lakeland Florida Recruiting
Innovative Clinical Research Lauderhill Florida Recruiting
K2 Medical Research - Maitland Maitland Florida Recruiting
K2 Medical Research ORLANDO Maitland Florida Recruiting
Life Arc Research Centers - Miami Miami Florida Recruiting
Wellness Research Center Miami Florida Recruiting
Life Medical Research Group Corp Miami Gardens Florida Recruiting
Charter Research - Orlando Orlando Florida Recruiting
K2 Medical Research - Tampa Tampa Florida Recruiting
Re:Cognition Health - Chicago Chicago Illinois Recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center Baltimore Maryland Recruiting
Maryland Treatment Centers - Avery Road Treatment Center Rockville Maryland Recruiting
Adams Clinical Boston Boston Massachusetts Recruiting
K2 Medical Research - Foxborough Foxborough Massachusetts Recruiting
Adams Clinical Bronx The Bronx New York Recruiting
North Star Medical Research Middleburg Heights Ohio Recruiting
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Recruiting
Brown University School of Public Health Providence Rhode Island Recruiting
Avera Research Institute - Sioux Falls Sioux Falls South Dakota Recruiting
Modern Research Associates, PLLC Dallas Texas Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
Biopharma Informatic, LLC Houston Texas Recruiting
Re:Cognition Health Fairfax Virginia Recruiting
ANIMA Research Diepenbeek Belgium Recruiting
Kormont Kluisbergen Belgium Recruiting
Gezondheidshuis De Gloed Machelen Belgium Recruiting
Meclinas Mechelen Belgium Recruiting
Medisch Centrum Saffrou Oudenaarde Belgium Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science Beijing China Recruiting
Beijing HuiLongGuan Hospital Beijing China Recruiting
The Second People's Hospital of Hunan Province Changsha China Recruiting
The Second Xiangya Hospital of Central South University Changsha China Recruiting
West China Hospital, Sichuan University Cheng Du Shi China Recruiting
The Fourth People's Hospital of Chengdu Chengdu China Recruiting

+ 76 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219953 on ClinicalTrials.gov ↗ ← All trials in the USA