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

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: LY3537031; Drug: Placebo

• Registration Number: NCT07219966
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-21
• Last Update Submitted: 2025-10-21
• Study First Posted: 2025-10-22
• Last Update Posted: 2025-10-22
• Study Start: 2025-12-01
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• 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 a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537031 Period 1	LY3537031	Escalating doses administered subcutaneously (SC)
LY3537031 Period 1	Placebo	Escalating doses administered subcutaneously (SC)
LY3537031 Period 2	LY3537031	Administered SC
LY3537031 Period 2	Placebo	Administered SC
Placebo	Placebo	Administered SC

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (126)

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

UCLA Clinical & Translational Research Center (CTRC); 🇺🇸 Los Angeles, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay; 🇺🇸 San Francisco, California, United States

Mountain Mind - Denver; 🇺🇸 Denver, Colorado, United States

K2 Medical Research - Maitland; 🇺🇸 Maitland, Florida, United States

K2 Medical Research ORLANDO; 🇺🇸 Maitland, Florida, United States

Life Arc Research Centers - Miami; 🇺🇸 Miami, Florida, United States

Wellness Research Center; 🇺🇸 Miami, Florida, United States

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