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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Eli Lilly and Company
Where
Baltimore, Birmingham, Boston, Chicago, Clinton, Dallas, Denver, DeSoto, Fairfax, Foxborough, Lakeland, Little Rock, Los Angeles, Maitland, Miami, Miami Gardens, Middleburg Heights, Orlando, Philadelphia, Richardson, Rockville, San Diego, San Francisco, Scottsdale, Seattle, Sioux Falls, Tampa, and The Bronx, United StatesSee the 30 sitesAlso in 7 other countries, 87 sites
Status
Recruiting
Phase
Phase 3
People taking part
1,100 people, planned
Started
15 Oct 2025
Expected to end
Apr 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LY3537031
  • Placebo
Record updated
7 October 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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)
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

Also in 7 other countries, 87 sites

  • Maryland Treatment Centers - Mountain Manor Treatment CenterBaltimore, United StatesNo longer taking part
  • Parkway Medical CenterBirmingham, United StatesNo longer taking part
  • Adams Clinical BostonBoston, United StatesNo longer taking part
  • Re:Cognition Health - ChicagoChicago, United StatesNo longer taking part
  • Alpine Research OrganizationClinton, United StatesNo longer taking part
  • UT Southwestern Medical CenterDallas, United StatesContact: Sherwood Brown (principal investigator)Taking people
  • Mountain Mind - DenverDenver, United StatesNo longer taking part
  • Adams Clinical DallasDeSoto, United StatesNo longer taking part
  • Re:Cognition HealthFairfax, United StatesNo longer taking part
  • K2 Medical Research - FoxboroughFoxborough, United StatesNo longer taking part
  • Accel Research Sites - Lakeland Clinical Research UnitLakeland, United StatesNo longer taking part
  • Woodland International Research GroupLittle Rock, United StatesNo longer taking part
  • UCLA Clinical & Translational Research Center (CTRC)Los Angeles, United StatesNo longer taking part
  • K2 Medical Research - MaitlandMaitland, United StatesNo longer taking part
  • K2 Medical Research ORLANDOMaitland, United StatesNo longer taking part
  • Life Arc Research Centers - MiamiMiami, United StatesNo longer taking part
  • Wellness Research CenterMiami, United StatesNo longer taking part
  • Life Medical Research Group CorpMiami Gardens, United StatesNo longer taking part
  • North Star Medical ResearchMiddleburg Heights, United StatesNo longer taking part
  • Charter Research - OrlandoOrlando, United StatesNo longer taking part
  • Penn Medicine: University of Pennsylvania Health SystemPhiladelphia, United StatesNo longer taking part
  • Pillar Clinical Research - RichardsonRichardson, United StatesNo longer taking part
  • Maryland Treatment Centers - Avery Road Treatment CenterRockville, United StatesContact: Marc Fishman (principal investigator)Taking people
  • Artemis Institute for Clinical ResearchSan Diego, United StatesNo longer taking part
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BaySan Francisco, United StatesNo longer taking part
  • Headlands Research - ScottsdaleScottsdale, United StatesNo longer taking part
  • University of Washington Medical Center - MontlakeSeattle, United StatesNo longer taking part
  • Avera Research Institute - Sioux FallsSioux Falls, United StatesNo longer taking part
  • K2 Medical Research - TampaTampa, United StatesNo longer taking part
  • Adams Clinical BronxThe Bronx, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • LY3537031 Period 1Treatment being tested

    Escalating doses administered subcutaneously (SC)

    Treatment: LY3537031 and Placebo

  • LY3537031 Period 2Treatment being tested

    Administered SC

    Treatment: LY3537031 and Placebo

  • PlaceboPlacebo, for comparison

    Administered SC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Fit questions
Built from NCT07219966, who can take part
Record updated
7 October 2026