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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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 facts

Study ID

NCT06817356

Run by

Eli Lilly and Company

People needed

308

Starts

2025-02-06

Expected to finish

2026-05-19

Last updated by the study team

2026-07-16

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• 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
• 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 — Orlando, Florida, 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
• 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
• Richmond Behavioral Associates — Staten Island, New York, United States
• Ichor Research — Syracuse, New York, United States
• Davis Clinical — The Bronx, 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
• Clinical Neuroscience Solutions Inc — Memphis, Tennessee, United States
• FutureSearch Trials of Dallas — Dallas, Texas, United States
• Dallas Clinical Research Center/Pillar Research — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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