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

Description

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.

Conditions

Alcohol Use Disorder

Study Overview

Study Details

Study overview

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.

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

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

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Headlands Research - Scottsdale, Scottsdale, Arizona, United States, 85260

Little Rock

Woodland International Research Group, Little Rock, Arkansas, United States, 72211

Rogers

Woodland Resarch Northwest/ERG, Rogers, Arkansas, United States, 72758

Fountain Valley

Ark Clinical Research - Fountain Valley, Fountain Valley, California, United States, 92708

Lemon Grove

Synergy San Diego, Lemon Grove, California, United States, 91945

San Diego

Headlands Research-Artemis San Diego, San Diego, California, United States, 92103

Hollywood

Research Centers of America ( Hollywood ), Hollywood, Florida, United States, 33024

Maitland

K2 Medical Research - Maitland, Maitland, Florida, United States, 32751

Maitland

K2 Medical Research, Maitland, Florida, United States, 32751

Orlando

Clinical Neuroscience Solutions Inc, Orlando, Florida, United States, 32801

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-08