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Clinical Trials/NCT06817356
NCT06817356CompletedPhase 2

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

Eli Lilly and Company46 sites in 1 country308 target enrollmentStarted: February 6, 2025Last updated:
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Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
308
Locations
46
Primary Endpoint
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Placebo

Placebo Comparator

Placebo administered SC.

Intervention: Placebo (Drug)

Mazdutide

Experimental

Mazdutide administered subcutaneously (SC).

Intervention: Mazdutide (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Week 28

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (46)

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