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

NCT ID: NCT06817356

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mazdutide

Mazdutide administered subcutaneously (SC).

Group Type EXPERIMENTAL

Mazdutide

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mazdutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3305677

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

Woodland International Research Group

Little Rock, Arkansas, United States

Site Status NOT_YET_RECRUITING

Woodland Resarch Northwest/ERG

Rogers, Arkansas, United States

Site Status RECRUITING

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States

Site Status RECRUITING

Synergy San Diego

Lemon Grove, California, United States

Site Status RECRUITING

Headlands Research-Artemis San Diego

San Diego, California, United States

Site Status RECRUITING

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Site Status RECRUITING

K2 Medical Research - Maitland

Maitland, Florida, United States

Site Status RECRUITING

K2 Medical Research

Maitland, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions Inc

Orlando, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status RECRUITING

K2 Medical Research - Tampa

Tampa, Florida, United States

Site Status RECRUITING

CenExel iResearch, LLC (CenExel iRA)

Decatur, Georgia, United States

Site Status RECRUITING

DelRicht Research

Mandeville, Louisiana, United States

Site Status RECRUITING

Adams Clinical

Watertown, Massachusetts, United States

Site Status RECRUITING

Vitalix Clinical

Worcester, Massachusetts, United States

Site Status RECRUITING

Redbird Research LLC

Las Vegas, Nevada, United States

Site Status RECRUITING

IMA Clinical Research Albuquerque

Albuquerque, New Mexico, United States

Site Status NOT_YET_RECRUITING

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status RECRUITING

Ichor Research

Syracuse, New York, United States

Site Status RECRUITING

Davis Clinical

The Bronx, New York, United States

Site Status RECRUITING

Summit Headlands

Portland, Oregon, United States

Site Status RECRUITING

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Clinical Neuroscience Solutions Inc

Memphis, Tennessee, United States

Site Status RECRUITING

FutureSearch Trials of Dallas

Dallas, Texas, United States

Site Status RECRUITING

Dallas Clinical Research Center/Pillar Research

Richardson, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

I8P-MC-OXAH

Identifier Type: OTHER

Identifier Source: secondary_id

27290

Identifier Type: -

Identifier Source: org_study_id