RECRUITING

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

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Conditions

Alcohol Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-06
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06817356

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.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
  1. * Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.
  2. * Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment.
  3. * Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.
  4. * Other protocol-specific inclusion and exclusion criteria may apply.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
3176154559
clinical_inquiry_hub@lilly.com

Principal Investigator

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

Study Locations (Sites)

Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
United States
Woodland International Research Group
Little Rock, Arkansas, 72211
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, 92103
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, 33607
United States
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, 30030
United States
DelRicht Research
Mandeville, Louisiana, 70741
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
IMA Clinical Research Albuquerque
Albuquerque, New Mexico, 87019
United States
Davis Clinical
Bronx, New York, 10461
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Ichor Research
Syracuse, New York, 13210
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

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder