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

Last updated: July 18, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Alcohol Use Disorder

Alcohol Dependence

Addictions

Treatment

Mazdutide

Placebo

Clinical Study ID

NCT06817356
27290
I8P-MC-OXAH
  • Ages 21-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Have a history of significant active or unstable major depressive disorder, suicidalideation, or other severe psychiatric disorder within the last 12 months.

  • Have initiated psychotherapy, changed the intensity of psychotherapy, or othernondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior toenrollment.

  • Have received any medication for AUD in the last 30 days including but not limitedto, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.

  • Other protocol-specific inclusion and exclusion criteria may apply.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Mazdutide
Phase: 2
Study Start date:
February 06, 2025
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Headlands Research - Scottsdale

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Woodland International Research Group

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Woodland Resarch Northwest/ERG

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Ark Clinical Research - Fountain Valley

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Synergy San Diego

    Lemon Grove, California 91945
    United States

    Active - Recruiting

  • Headlands Research-Artemis San Diego

    San Diego, California 92103
    United States

    Active - Recruiting

  • Research Centers of America ( Hollywood )

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • K2 Medical Research - Maitland

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • K2 Medical Research - Tampa

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • CenExel iResearch, LLC (CenExel iRA)

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • DelRicht Research

    Mandeville, Louisiana 70471
    United States

    Active - Recruiting

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Vitalix Clinical

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Redbird Research LLC

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • IMA Clinical Research Albuquerque

    Albuquerque, New Mexico 87019
    United States

    Active - Recruiting

  • Davis Clinical

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Richmond Behavioral Associates

    Staten Island, New York 10314
    United States

    Active - Recruiting

  • Ichor Research

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Summit Headlands

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • FutureSearch Trials of Dallas

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Dallas Clinical Research Center/Pillar Research

    Richardson, Texas 75080
    United States

    Active - Recruiting

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