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

Launched by ELI LILLY AND COMPANY · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called mazdutide for people who have Alcohol Use Disorder (AUD), which means they have a strong dependence on alcohol. The goal of the study is to see if mazdutide can help reduce the symptoms of AUD compared to a placebo, which is a substance that looks like the treatment but has no active ingredients. Participants in the study will be involved for about 36 weeks, which includes time for screening and follow-up after treatment.

To be eligible for the trial, participants must be diagnosed with AUD according to specific guidelines. However, individuals who have had serious mental health issues, like major depression or suicidal thoughts, within the past year, or those who have recently started or changed their therapy, will not be able to join. Also, anyone who has taken medications for AUD in the last 30 days will not qualify. This study is not yet recruiting participants, but once it begins, the researchers hope to find out more about how effective mazdutide can be in helping individuals manage their alcohol use.

Gender

ALL

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.