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

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

  • Alcohol Use Disorder

Eligibility

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

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

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 4049979, Alabama 4829764 35215
Contact:
205-876-2601

Headlands Research - Scottsdale
Scottsdale 5313457, Arizona 5551752 85260

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92103
Contact:
619-915-0496

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco 5391959, California 5332921 94158

Mountain Mind - Denver
Denver 5419384, Colorado 5417618 80202

K2 Medical Research - Maitland
Maitland 4163220, Florida 4155751 32751

K2 Medical Research ORLANDO
Maitland 4163220, Florida 4155751 32751
Contact:
407-500-5252

Life Arc Research Centers - Miami
Miami 4164138, Florida 4155751 33126
Contact:
305-874-7401

Wellness Research Center
Miami 4164138, Florida 4155751 33135
Contact:
305-300-2623

Charter Research - Orlando
Orlando 4167147, Florida 4155751 32803

K2 Medical Research - Tampa
Tampa 4174757, Florida 4155751 33607
Contact:
813-800-5252

Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore 4347778, Maryland 4361885 21229

Adams Clinical Bronx
The Bronx 5110266, New York 5128638 10461

North Star Medical Research
Middleburg Heights 5162851, Ohio 5165418 44130

Penn Medicine: University of Pennsylvania Health System
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
215-746-1943

Adams Clinical Dallas
DeSoto 4685524, Texas 4736286 75115

Pillar Clinical Research - Richardson
Richardson 4722625, Texas 4736286 75080
Contact:
214-396-4844

Alpine Research Organization
Clinton 5773001, Utah 5549030 84015
Contact:
801-928-3292

Re:Cognition Health
Fairfax 4758023, Virginia 6254928 22031

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