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

NCT06817356
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
308
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Lead sponsor
Eli Lilly and Company
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Start date
2025-02-06
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Number of sites
25
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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.
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Short title
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
clinicaltrials.gov
Official title
A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-05-19
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First posted
2025-02-10
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Registry last updated
2026-07-16
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Primary completion date
2026-03-19
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Start date
2025-02-06
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Actual participants
308
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Participants
308
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
25
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06817356
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ClinicalTrials.gov ID
NCT06817356
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline, Week 28

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
21 Years
Maximum age
65 Years
Healthy volunteers
No

  • Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 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.
Sources for eligibility
clinicaltrials.gov

  • Headlands Research - ScottsdaleScottsdale, United States
  • Woodland Resarch Northwest/ERGRogers, United States
  • Ark Clinical Research - Fountain ValleyFountain Valley, United States
  • Synergy San DiegoLemon Grove, United States
  • Headlands Research-Artemis San DiegoSan Diego, United States
  • Research Centers of America ( Hollywood )Hollywood, United States
  • K2 Medical Research - MaitlandMaitland, United States
  • K2 Medical ResearchMaitland, United States
  • Clinical Neuroscience Solutions IncOrlando, United States
  • Clinical Neuroscience Solutions, Inc.Orlando, United States
  • K2 Medical Research - TampaTampa, United States
  • CenExel iResearch, LLC (CenExel iRA)Decatur, United States
  • DelRicht ResearchMandeville, United States
  • Adams ClinicalWatertown, United States
  • Vitalix ClinicalWorcester, United States
  • Redbird Research LLCLas Vegas, United States
  • Richmond Behavioral AssociatesStaten Island, United States
  • Ichor ResearchSyracuse, United States
  • Davis ClinicalThe Bronx, United States
  • Summit HeadlandsPortland, United States
  • Rhode Island Mood & Memory Research InstituteEast Providence, United States
  • Medical University of South CarolinaCharleston, United States
  • Clinical Neuroscience Solutions IncMemphis, United States
  • FutureSearch Trials of DallasDallas, United States
  • Dallas Clinical Research Center/Pillar ResearchRichardson, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • I8P-MC-OXAH
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)