Active not recruitingPhase 2

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

Lead sponsor

Eli Lilly and Company

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Estimated enrollment

308

Study population

Alcohol / substance use

Eligibility highlights

Primary endpoint

•Alcohol consumption, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06817356

Org study ID27290

Secondary IDI8P-MC-OXAHEli Lilly and Company

Timeline

Milestones

Study start2025-02-06actual

Study first posted2025-02-10actual

Last update posted2026-03-27actual

Primary completion2026-08estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Investigational agents

Mazdutide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot 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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method

Time frame:Baseline, Week 28

Alcohol consumption, change

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.