A Study of Brenipatide in Participants With 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 Alcohol Use Disorder (AUD) and hazardous alcohol use. 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
- 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 Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LY3537031 Period 1 |
Escalating doses administered subcutaneously (SC) |
|
|
Experimental LY3537031 Period 2 |
Administered SC |
|
|
Placebo Comparator Placebo |
Administered SC |
|
Recruiting Locations
Headlands Research - Scottsdale
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
310-794-5383
310-794-5383
Artemis Institute for Clinical Research
Riverside, California 92503
Riverside, California 92503
Contact:
951-374-1190
951-374-1190
Artemis Institute for Clinical Research
San Diego, California 92123
San Diego, California 92123
Contact:
858-278-3647
858-278-3647
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California 94158
San Francisco, California 94158
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33803
Lakeland, Florida 33803
Contact:
863-940-2087
863-940-2087
K2 Medical Research - Maitland
Maitland, Florida 32751
Maitland, Florida 32751
K2 Medical Research ORLANDO
Maitland, Florida 32751
Maitland, Florida 32751
Contact:
407-500-5252
407-500-5252
Life Arc Research Centers - Miami
Miami, Florida 33126
Miami, Florida 33126
Contact:
305-874-7401
305-874-7401
Wellness Research Center
Miami, Florida 33135
Miami, Florida 33135
Contact:
305-300-2623
305-300-2623
Life Medical Research Group Corp
Miami Gardens, Florida 33014
Miami Gardens, Florida 33014
Contact:
305-705-4111
305-705-4111
Charter Research - Orlando
Orlando, Florida 32803
Orlando, Florida 32803
K2 Medical Research - Tampa
Tampa, Florida 33634
Tampa, Florida 33634
Contact:
813-800-5252
813-800-5252
Re:Cognition Health - Chicago
Chicago, Illinois 60611
Chicago, Illinois 60611
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland 21229
Baltimore, Maryland 21229
Adams Clinical Boston
Boston, Massachusetts 02116
Boston, Massachusetts 02116
Adams Clinical Bronx
The Bronx, New York 10461
The Bronx, New York 10461
North Star Medical Research
Middleburg Heights, Ohio 44130
Middleburg Heights, Ohio 44130
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Contact:
215-746-1943
215-746-1943
K2 Medical Research - East Providence
East Providence, Rhode Island 02914
East Providence, Rhode Island 02914
Contact:
401-435-8950
401-435-8950
Brown University School of Public Health
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
Contact:
605-504-3154
605-504-3154
Modern Research Associates, PLLC
Dallas, Texas 75231
Dallas, Texas 75231
Adams Clinical Dallas
DeSoto, Texas 75115
DeSoto, Texas 75115
Biopharma Informatic, LLC
Houston, Texas 77043
Houston, Texas 77043
Contact:
281-944-3610
281-944-3610
Re:Cognition Health
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com