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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Mazdutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06817356

I8P-MC-OXAH (Other Identifier)

27290

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Mazdutide

Experimental group

Description:

Mazdutide administered subcutaneously (SC).

Treatment:

Drug: Mazdutide

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo