Brenipatide for moderate-to-severe alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3, placebo-controlled trial participants will be randomly assigned to receive either brenipatide (LY3537031) or a matching placebo and followed for about 56 weeks. Participants will self-administer the blinded injections, complete electronic and paper diaries, and attend regular clinic visits to record drinking, symptoms, and side effects. Safety monitoring and standardized questionnaires will be used to track outcomes over the treatment period. The trial is sponsored by Eli Lilly and conducted at multiple clinical research sites.

Why it matters

Who can join: the full rules

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).

Where it's running

• Maryland Treatment Centers - Avery Road Treatment Center
  Rockville, Maryland, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Seoul National University Bundang Hospital
  Seongnam, South Korea Recruiting
• The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  Uijeongbu-si, South Korea Recruiting
• Parkway Medical Center
  Birmingham, Alabama, United States Completed
• Headlands Research - Scottsdale
  Scottsdale, Arizona, United States Active not recruiting

+67 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.