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A Study of Brenipatide in Participants With Alcohol Use Disorder

NCT07219953

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Alcohol Use Disorder

Interventions: LY3537031, Placebo

Countries: United States, Belgium, China, Germany, Japan, South Korea, Taiwan, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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).

Locations (116)

Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Riverside, California, United States
San Diego, California, United States
San Francisco, California, United States
Lakeland, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Gardens, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Foxborough, Massachusetts, United States
The Bronx, New York, United States
Middleburg Heights, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Diepenbeek, Belgium
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