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CompletedPhase 2

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

Key facts

Who runs it
Eli Lilly and Company
Where
Charleston, Dallas, Decatur, East Providence, Fountain Valley, Hollywood, Las Vegas, Lemon Grove, Maitland, Mandeville, Memphis, Orlando, Portland, Richardson, Rogers, San Diego, Scottsdale, Staten Island, Syracuse, Tampa, The Bronx, Watertown, and Worcester, United StatesSee the 24 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
308 people enrolled
Started
6 Feb 2025
Ended
19 May 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Mazdutide
  • Placebo
Record updated
16 July 2026

Who can take part

Age
21 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria

Who cannot take part

  • Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment
  • Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate
  • Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months
  • Other protocol-specific inclusion and exclusion criteria may apply

Where in United States

  • Medical University of South CarolinaCharleston, United States
  • FutureSearch Trials of DallasDallas, United States
  • CenExel iResearch, LLC (CenExel iRA)Decatur, United States
  • Rhode Island Mood & Memory Research InstituteEast Providence, United States
  • Ark Clinical Research, Fountain ValleyFountain Valley, United States
  • Research Centers of America (Hollywood)Hollywood, United States
  • Redbird Research, LLCLas Vegas, United States
  • Synergy San DiegoLemon Grove, United States
  • K2 Medical ResearchMaitland, United States
  • K2 Medical Research - MaitlandMaitland, United States
  • DelRicht ResearchMandeville, United States
  • Clinical Neuroscience Solutions, Inc.Memphis, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • Summit HeadlandsPortland, United States
  • Dallas Clinical Research Center/Pillar ResearchRichardson, United States
  • Woodland Resarch Northwest/ERGRogers, United States
  • Headlands Research-Artemis San DiegoSan Diego, United States
  • Headlands Research - ScottsdaleScottsdale, United States
  • Richmond Behavioral AssociatesStaten Island, United States
  • Ichor ResearchSyracuse, United States
  • K2 Medical Research - TampaTampa, United States
  • Davis ClinicalThe Bronx, United States
  • Adams ClinicalWatertown, United States
  • Vitalix ClinicalWorcester, United States

About the trial

What the trial wants to find out

The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).

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For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.

The 2 groups in the trial

  • MazdutideTreatment being tested

    Mazdutide administered subcutaneously (SC).

  • PlaceboPlacebo, for comparison

    Placebo administered SC.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Record updated
16 July 2026