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

March 26, 2026 updated by: Eli Lilly and Company

A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Headlands Research - Scottsdale
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Woodland Resarch Northwest/ERG
    • California
      • Fountain Valley, California, United States, 92708
        • ARK Clinical Research - Fountain Valley
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • San Diego, California, United States, 92123
        • Headlands Research-Artemis San Diego
    • Florida
      • Hollywood, Florida, United States, 33024
        • Research Centers of America ( Hollywood )
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Maitland, Florida, United States, 32751
        • K2 Medical Research - Maitland
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32801
        • Clinical NeuroScience Solutions Inc
      • Tampa, Florida, United States, 33634
        • K2 Medical Research - Tampa
    • Georgia
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC (CenExel iRA)
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • DelRicht Research
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical
      • Worcester, Massachusetts, United States, 01608
        • Vitalix Clinical
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Redbird Research LLC
    • New York
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates
      • Syracuse, New York, United States, 13210
        • Ichor Research
      • The Bronx, New York, United States, 10461
        • Davis Clinical
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Mood & Memory Research Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical NeuroScience Solutions Inc
    • Texas
      • Dallas, Texas, United States, 75251
        • FutureSearch Trials of Dallas
      • Richardson, Texas, United States, 75080
        • Dallas Clinical Research Center/Pillar Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.
  • 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.
  • Other protocol-specific inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC
Experimental: Mazdutide
Mazdutide administered subcutaneously (SC).
Drug: Mazdutide
Administered SC
Other Names:
  • LY3305677

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27290
  • I8P-MC-OXAH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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