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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3537031 Period 1 		Escalating doses administered subcutaneously (SC)
  • Drug: LY3537031
    Administered SC
    Other names:
    • Brenipatide
  • Drug: Placebo
    Administered SC
Experimental
LY3537031 Period 2 		Administered SC
  • Drug: LY3537031
    Administered SC
    Other names:
    • Brenipatide
  • Drug: Placebo
    Administered SC
Placebo Comparator
Placebo 		Administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Parkway Medical Center
Birmingham, Alabama 35215
Contact:
205-876-2601

Headlands Research - Scottsdale
Scottsdale, Arizona 85260

UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California 90095
Contact:
310-794-5383

Artemis Institute for Clinical Research
San Diego, California 92123
Contact:
858-278-3647

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California 94158

Mountain Mind - Denver
Denver, Colorado 80202

Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33803
Contact:
863-940-2087

K2 Medical Research - Maitland
Maitland, Florida 32751

K2 Medical Research ORLANDO
Maitland, Florida 32751
Contact:
407-500-5252

Life Arc Research Centers - Miami
Miami, Florida 33126
Contact:
305-874-7401

Wellness Research Center
Miami, Florida 33135
Contact:
305-300-2623

Life Medical Research Group Corp
Miami Gardens, Florida 33014
Contact:
305-705-4111

Charter Research - Orlando
Orlando, Florida 32803

K2 Medical Research - Tampa
Tampa, Florida 33634
Contact:
813-800-5252

Re:Cognition Health - Chicago
Chicago, Illinois 60611

Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland 21229

Adams Clinical Boston
Boston, Massachusetts 02116

Adams Clinical Bronx
The Bronx, New York 10461

North Star Medical Research
Middleburg Heights, Ohio 44130

Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
Contact:
215-746-1943

K2 Medical Research - East Providence
East Providence, Rhode Island 02914
Contact:
401-435-8950

Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota 57108
Contact:
605-504-3154

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
214-645-6950

Adams Clinical Dallas
DeSoto, Texas 75115

Pillar Clinical Research - Richardson
Richardson, Texas 75080
Contact:
214-396-4844

Alpine Research Organization
Clinton, Utah 84015
Contact:
801-928-3292

Re:Cognition Health
Fairfax, Virginia 22031

University of Washington Medical Center - Montlake
Seattle, Washington 98195

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.