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

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Placebo; Drug: Mazdutide

• Registration Number: NCT06817356
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study Start: 2025-02-06
• Study First Posted: 2025-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered SC.
Mazdutide	Mazdutide	Mazdutide administered subcutaneously (SC).

Primary Outcome Measures

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

Trial Locations

Locations (26)

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Woodland Resarch Northwest/ERG; 🇺🇸 Rogers, Arkansas, United States

Ark Clinical Research - Fountain Valley; 🇺🇸 Fountain Valley, California, United States

Synergy San Diego; 🇺🇸 Lemon Grove, California, United States

DelRicht Research; 🇺🇸 Mandeville, Louisiana, United States

Adams Clinical; 🇺🇸 Watertown, Massachusetts, United States

Vitalix Clinical; 🇺🇸 Worcester, Massachusetts, United States

Redbird Research LLC; 🇺🇸 Las Vegas, Nevada, United States

FutureSearch Trials of Dallas; 🇺🇸 Dallas, Texas, United States

Headlands Research-Artemis San Diego; 🇺🇸 San Diego, California, United States

Research Centers of America ( Hollywood ); 🇺🇸 Hollywood, Florida, United States

K2 Medical Research - Maitland; 🇺🇸 Maitland, Florida, United States

K2 Medical Research; 🇺🇸 Maitland, Florida, United States

Clinical Neuroscience Solutions Inc; 🇺🇸 Memphis, Tennessee, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Orlando, Florida, United States

K2 Medical Research - Tampa; 🇺🇸 Tampa, Florida, United States

CenExel iResearch, LLC (CenExel iRA); 🇺🇸 Decatur, Georgia, United States

IMA Clinical Research Albuquerque; 🇺🇸 Albuquerque, New Mexico, United States

Davis Clinical; 🇺🇸 Bronx, New York, United States

Richmond Behavioral Associates; 🇺🇸 Staten Island, New York, United States

Ichor Research; 🇺🇸 Syracuse, New York, United States

Summit Headlands; 🇺🇸 Portland, Oregon, United States

Rhode Island Mood & Memory Research Institute; 🇺🇸 East Providence, Rhode Island, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Dallas Clinical Research Center/Pillar Research; 🇺🇸 Richardson, Texas, United States