A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
2 other identifiers
interventional
300
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
March 27, 2026
March 1, 2026
1.5 years
February 5, 2025
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
Baseline, Week 28
Study Arms (2)
Mazdutide
EXPERIMENTALMazdutide administered subcutaneously (SC).
Placebo
PLACEBO COMPARATORPlacebo administered SC.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
Woodland Resarch Northwest/ERG
Rogers, Arkansas, 72758, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Headlands Research-Artemis San Diego
San Diego, California, 92123, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024, United States
K2 Medical Research - Maitland
Maitland, Florida, 32751, United States
K2 Medical Research
Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
K2 Medical Research - Tampa
Tampa, Florida, 33634, United States
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, 30030, United States
DelRicht Research
Mandeville, Louisiana, 70471, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
Vitalix Clinical
Worcester, Massachusetts, 01608, United States
Redbird Research LLC
Las Vegas, Nevada, 89119, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
Ichor Research
Syracuse, New York, 13210, United States
Davis Clinical
The Bronx, New York, 10461, United States
Summit Headlands
Portland, Oregon, 97210, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
Dallas Clinical Research Center/Pillar Research
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 10, 2025
Study Start
February 6, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.