A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Alcohol Use Disorder

Treatments: Drug: LY3537031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219966

2025-522313-38-00 (EU Trial (CTIS) Number)

27346

J2S-MC-GZME (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,100 participants in 3 patient groups, including a placebo group

LY3537031 Period 1

Experimental group

Description:

Escalating doses administered subcutaneously (SC)

Treatment:

Drug: Placebo

Drug: LY3537031

LY3537031 Period 2

Experimental group

Description:

Administered SC

Treatment:

Drug: Placebo

Drug: LY3537031

Placebo

Placebo Comparator group

Description:

Administered SC

Treatment:

Drug: Placebo