Clinical trial NCT06817356: A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Official title: A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
timeFrame: Baseline, Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Resarch Northwest/ERG
state: Arkansas
city: Fountain Valley
country: United States
facility: Ark Clinical Research - Fountain Valley
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: San Diego
country: United States
facility: Headlands Research-Artemis San Diego
state: California
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research - Maitland
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research - Tampa
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch, LLC (CenExel iRA)
state: Georgia
city: Mandeville
country: United States
facility: DelRicht Research
state: Louisiana
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Worcester
country: United States
facility: Vitalix Clinical
state: Massachusetts
city: Las Vegas
country: United States
facility: Redbird Research LLC
state: Nevada
city: Albuquerque
country: United States
facility: IMA Clinical Research Albuquerque
state: New Mexico
city: Bronx
country: United States
facility: Davis Clinical
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Syracuse
country: United States
facility: Ichor Research
state: New York
city: Portland
country: United States
facility: Summit Headlands
state: Oregon
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Richardson
country: United States
facility: Dallas Clinical Research Center/Pillar Research
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: