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Evaluating Mazdutide for Alcohol Use Disorder

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

Phase 2 Interventional Eli Lilly and Company · NCT06817356

This study is testing if a new medication called mazdutide can help people with alcohol use disorder reduce their symptoms better than a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages21 Years to 65 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations27 sites (Scottsdale, Arizona and 26 other locations)
Trial IDNCT06817356 on ClinicalTrials.gov

What this trial studies

This proof-of-concept study aims to evaluate the efficacy of mazdutide compared to a placebo in participants diagnosed with alcohol use disorder (AUD). Participants will undergo a maximum of 36 weeks of study participation, which includes screening and post-treatment follow-up. The study will assess the impact of mazdutide on reducing symptoms of AUD, with careful monitoring of participants' mental health and adherence to eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with alcohol use disorder as per DSM-5 criteria.

Not a fit: Patients with significant psychiatric disorders or those who have recently changed their treatment for AUD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with alcohol use disorder.

How similar studies have performed: While this approach is relatively novel, similar studies targeting alcohol use disorder have shown promise in exploring new treatment options.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alcohol Use Disorder
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.