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

Official title

A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Overview

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.

Interventions

• Drug LY3537031
  Administered SC
• Drug Placebo
  Administered SC

Primary outcome measures

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

Secondary outcome measures (7)

• Change in Daily Alcohol Consumption as Assessed by the TLFB [Time frame: Up to 56 weeks]
• Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS) [Time frame: Baseline up to Week 56]
• Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score [Time frame: Baseline up to Week 56]
• Mean Change in Body Weight [Time frame: 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 [Time frame: Baseline up to Week 56]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Baseline up to Week 56]
• Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA) [Time frame: Baseline up to Week 56]

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
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 30 centers

• Parkway Medical Center — Birmingham
• Headlands Research - Scottsdale — Scottsdale
• Woodland International Research Group — Little Rock
• UCLA Clinical & Translational Research Center (CTRC) — Los Angeles
• Artemis Institute for Clinical Research — San Diego
• UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay — San Francisco
• Mountain Mind - Denver — Denver
• Accel Research Sites - Lakeland Clinical Research Unit — Lakeland
• … and 22 more centers

China · 27 centers

• Beijing Anding Hospital - Affiliated Capital University of Medical Science — Beijing
• Beijing HuiLongGuan Hospital — Beijing
• The Second People's Hospital of Hunan Province — Changsha
• The Second Xiangya Hospital of Central South University — Changsha
• West China Hospital, Sichuan University — Cheng Du Shi
• The Fourth People's Hospital of Chengdu — Chengdu
• Guangzhou Brain Hospital — Guangzhou
• The Seventh People's Hospital of Hangzhou — Hangzhou
• … and 19 more centers

Japan · 20 centers

• Tokyo-Eki Center-building Clinic — Chūōku
• Ai Sakura Clinic — Fukuoka
• Hiro Mental Clinic — Fukuoka
• Kuramitsu Hospital — Fukuoka
• Rainbow and Sea Hospital — Karatsu
• Kariya Hospital — Kariya
• Tatsuta Clinic — Kobe
• Arata Clinic — Nagasaki
• … and 12 more centers

South Korea · 14 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 10 centers

Center list to be confirmed — check the primary protocol.

Germany · 7 centers

• FutureMeds GmbH — Berlin
• Velocity Clinical Research, Berlin — Berlin
• Klinische Forschung Dresden — Dresden
• Klinische Forschung Hamburg — Hamburg
• Zentralinstitut für Seelische Gesundheit — Mannheim
• Dedicated Research Site FutureMeds — Offenbach
• Klinische forschung Schwerin GmbH — Schwerin

Taiwan · 6 centers

Center list to be confirmed — check the primary protocol.

Belgium · 5 centers

• ANIMA Research — Diepenbeek
• Kormont — Kluisbergen
• Gezondheidshuis De Gloed — Machelen
• Meclinas — Mechelen
• Medisch Centrum Saffrou — Oudenaarde

Identifiers

NCT: NCT07219966 · 27346 · 2025-522313-38-00 · J2S-MC-GZME

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗