A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT06817356
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD). For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.

Key Dates

Start date
Feb 6, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mazdutide
    Mazdutide administered subcutaneously (SC).
  • Placebo Comparator: Placebo
    Placebo administered SC.

Primary Outcome Measure

Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method [ Time Frame: Baseline, Week 28 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Headlands Research - ScottsdaleScottsdaleArizona85260-
Woodland Resarch Northwest/ERGRogersArkansas72758-
Ark Clinical Research - Fountain ValleyFountain ValleyCalifornia92708-
Synergy San DiegoLemon GroveCalifornia91945-
Headlands Research-Artemis San DiegoSan DiegoCalifornia92123-
Research Centers of America ( Hollywood )HollywoodFlorida33024-
K2 Medical ResearchMaitlandFlorida32751-
K2 Medical Research - MaitlandMaitlandFlorida32751-
Clinical Neuroscience Solutions IncOrlandoFlorida32801-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
K2 Medical Research - TampaTampaFlorida33634-
CenExel iResearch, LLC (CenExel iRA)DecaturGeorgia30030-
DelRicht ResearchMandevilleLouisiana70471-
Adams ClinicalWatertownMassachusetts02472-
Vitalix ClinicalWorcesterMassachusetts01608-
Redbird Research LLCLas VegasNevada89119-
Richmond Behavioral AssociatesStaten IslandNew York10314-
Ichor ResearchSyracuseNew York13210-
Davis ClinicalThe BronxNew York10461-
Summit HeadlandsPortlandOregon97210-
Rhode Island Mood & Memory Research InstituteEast ProvidenceRhode Island02914-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Clinical Neuroscience Solutions IncMemphisTennessee38119-
FutureSearch Trials of DallasDallasTexas75251-
Dallas Clinical Research Center/Pillar ResearchRichardsonTexas75080-

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