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Not recruiting
Phase 2

Mazdutide

Sponsor:

Eli Lilly and Company

Code:

NCT06817356

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Mazdutide

Placebo

Study Details

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.

Conditions

Alcohol Use Disorder

Study ID

NCT06817356

Start date

Feb 6, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not 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.
  • Other protocol-specific inclusion and exclusion criteria may apply.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Mazdutide

Mazdutide administered subcutaneously (SC).

placebo comparator: Placebo

Placebo administered SC.

Interventions

Mazdutide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method [ Time Frame: Baseline, Week 28 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Headlands Research - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

480-330-7485

Principal Investigator:

Brandon Lawrence

Woodland Resarch Northwest/ERG

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

479-927-3000

Principal Investigator:

Robert Billingsley

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

714-988-2021

Principal Investigator:

Justin Yanuck

Synergy San Diego

Recruiting

Lemon Grove, California, United States, 91945

Contacts

619-303-6130

Principal Investigator:

Charmaine Semeniuk

Headlands Research-Artemis San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

858-278-3647

Principal Investigator:

Eric Chavez

Research Centers of America ( Hollywood )

Recruiting

Hollywood, Florida, United States, 33024

Contacts

954-990-7649

Principal Investigator:

Edwin Gomez

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-676-5252

Principal Investigator:

Sejal Patel

K2 Medical Research

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brady Bradshaw

Clinical Neuroscience Solutions Inc

Recruiting

Orlando, Florida, United States, 32801

Contacts

904-281-5757

Principal Investigator:

Mark Joyce

Clinical Neuroscience Solutions, Inc.

Recruiting

Orlando, Florida, United States, 32801

Contacts

407-425-5100

Principal Investigator:

Robert Molpus

K2 Medical Research - Tampa

Recruiting

Tampa, Florida, United States, 33607

Contacts

813-500-5252

Principal Investigator:

Kelley Yokum

CenExel iResearch, LLC (CenExel iRA)

Recruiting

Decatur, Georgia, United States, 30030

Contacts

404-537-1281

Principal Investigator:

Kimball Johnson

DelRicht Research

Recruiting

Mandeville, Louisiana, United States, 70471

Contacts

504-336-2667

Principal Investigator:

Rachel Murphy

Adams Clinical

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

617-744-8542

Principal Investigator:

Daniel Rutrick

Vitalix Clinical

Recruiting

Worcester, Massachusetts, United States, 01608

Contacts

413-363-5206

Principal Investigator:

James Carroll

Redbird Research LLC

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

702-577-2000

Principal Investigator:

Jelena Kunovac

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

Contacts

718-751-6750

Principal Investigator:

Adam Smith

Ichor Research

Recruiting

Syracuse, New York, United States, 13210

Contacts

315-904-5004

Principal Investigator:

Karl Hafner

Davis Clinical

Recruiting

The Bronx, New York, United States, 10461

Contacts

646-568-5162

Principal Investigator:

Shama Farooq

Summit Headlands

Recruiting

Portland, Oregon, United States, 97210

Contacts

503-314-3900

Principal Investigator:

Beal Essink

Rhode Island Mood & Memory Research Institute

Recruiting

East Providence, Rhode Island, United States, 02914

Contacts

401-435-8950

Principal Investigator:

john stoukides

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Sarah Book

Clinical Neuroscience Solutions Inc

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

901-843-1045

Principal Investigator:

Lora McGill

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

Contacts

214-369-2600

Principal Investigator:

Michael Downing

Dallas Clinical Research Center/Pillar Research

Recruiting

Richardson, Texas, United States, 75080

Contacts

214-396-4844

Principal Investigator:

Scott Bartley

More Information

Sponsor

Eli Lilly and Company

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2025-12-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.