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

• LY3537031 (Drug), also known as Brenipatide: Administered SC
• Placebo (Drug): Administered SC

Primary outcomes

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

Secondary outcomes

• Change in Daily Alcohol Consumption as Assessed by the TLFB [Up to 56 weeks]
• Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS) [Baseline up to Week 56]
• Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score [Baseline up to Week 56]
• Mean Change in Body Weight [Baseline up to Week 56]
• Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores [Baseline up to Week 56]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Baseline up to Week 56]
• Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA) [Baseline up to Week 56]

Sex: All, ages: 18 Years to 75 Years

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).

17 more sites not listed.

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company

NIH grants: 2025