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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07219966
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3537031 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3537031 Period 1
    Escalating doses administered subcutaneously (SC)
  • Experimental: LY3537031 Period 2
    Administered SC
  • Placebo Comparator: Placebo
    Administered SC

Primary Outcome Measure

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

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (30)

FacilityCityStateZIPSite coordinators
Parkway Medical CenterBirminghamAlabama35215
205-876-2601
James Sullivan (PRINCIPAL_INVESTIGATOR)
Headlands Research - ScottsdaleScottsdaleArizona85260
Rosika McKinney (PRINCIPAL_INVESTIGATOR)
Woodland International Research GroupLittle RockArkansas72211
501-221-8681
George Konis (PRINCIPAL_INVESTIGATOR)
UCLA Clinical & Translational Research Center (CTRC)Los AngelesCalifornia90095
310-794-5383
Lara Ray (PRINCIPAL_INVESTIGATOR)
Artemis Institute for Clinical ResearchSan DiegoCalifornia92123
858-278-3647
Eric Chavez (PRINCIPAL_INVESTIGATOR)
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BaySan FranciscoCalifornia94158
Khaled Moussawi (PRINCIPAL_INVESTIGATOR)
Mountain Mind - DenverDenverColorado80202
Larry Sanders (PRINCIPAL_INVESTIGATOR)
Accel Research Sites - Lakeland Clinical Research UnitLakelandFlorida33803
863-940-2087
James Andersen (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - MaitlandMaitlandFlorida32751
Sejal Patel (PRINCIPAL_INVESTIGATOR)
K2 Medical Research ORLANDOMaitlandFlorida32751
407-500-5252
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Life Arc Research Centers - MiamiMiamiFlorida33126
305-874-7401
Damian Casadesus (PRINCIPAL_INVESTIGATOR)
Wellness Research CenterMiamiFlorida33135
305-300-2623
Emilio Mantero-Atienza (PRINCIPAL_INVESTIGATOR)
Life Medical Research Group CorpMiami GardensFlorida33014
305-705-4111
Rafael Conte (PRINCIPAL_INVESTIGATOR)
Charter Research - OrlandoOrlandoFlorida32803
Jorel Martinez (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - TampaTampaFlorida33634
813-800-5252
Kelley Wilson (PRINCIPAL_INVESTIGATOR)
Re:Cognition Health - ChicagoChicagoIllinois60611
Abid Nazeer (PRINCIPAL_INVESTIGATOR)
Maryland Treatment Centers - Mountain Manor Treatment CenterBaltimoreMaryland21229
Marc Fishman (PRINCIPAL_INVESTIGATOR)
Maryland Treatment Centers - Avery Road Treatment CenterRockvilleMaryland20853
Marc Fishman (PRINCIPAL_INVESTIGATOR)
Adams Clinical BostonBostonMassachusetts02116
Darin Dougherty (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - FoxboroughFoxboroughMassachusetts02035
401-435-8950
john stoukides (PRINCIPAL_INVESTIGATOR)
Adams Clinical BronxThe BronxNew York10461
Shama Farooq (PRINCIPAL_INVESTIGATOR)
North Star Medical ResearchMiddleburg HeightsOhio44130
Mark Woyshville (PRINCIPAL_INVESTIGATOR)
Penn Medicine: University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104
215-746-1943
Henry Kranzler (PRINCIPAL_INVESTIGATOR)
Avera Research Institute - Sioux FallsSioux FallsSouth Dakota57108
605-504-3154
Vivek Anand (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
214-645-6950
Sherwood Brown (PRINCIPAL_INVESTIGATOR)
Adams Clinical DallasDeSotoTexas75115
Benji Kurian (PRINCIPAL_INVESTIGATOR)
Pillar Clinical Research - RichardsonRichardsonTexas75080
214-396-4844
Scott Bartley (PRINCIPAL_INVESTIGATOR)
Alpine Research OrganizationClintonUtah84015
801-928-3292
Michael Roundy (PRINCIPAL_INVESTIGATOR)
Re:Cognition HealthFairfaxVirginia22031
Scott Williams (PRINCIPAL_INVESTIGATOR)
University of Washington Medical Center - MontlakeSeattleWashington98195
Mark Duncan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Parkway Medical Center· Birmingham, ALHeadlands Research - Scottsdale· Scottsdale, AZWoodland International Research Group· Little Rock, ARUCLA Clinical & Translational Research Center (CTRC)· Los Angeles, CAArtemis Institute for Clinical Research· San Diego, CAUCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay· San Francisco, CA

Related Studies