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Active Not Recruiting
NCT06817356
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
Conditions: Alcohol Use Disorder
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 308
Sponsor: Eli Lilly and Company
Location: Headlands Research - Scottsdale Scottsdale Arizona
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.
Source: ClinicalTrials.gov (NCT06817356). StuddyBuddy aggregates publicly available trial information.