> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-mazdutide-compared-with-placebo-in-c7c6096f-de34-47a2-b41f-0e6018073689 > Record changed: 2026-10-13 # A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder NCT06817356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Participants 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Start date 2025-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) Number of sites 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Short title** A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Official title** A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Dates **Completion date** 2026-05-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **First posted** 2025-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Primary completion date** 2026-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Start date** 2025-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Size and sites **Actual participants** 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Participants** 308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Number of sites** 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Identifiers **Registry ID** NCT06817356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **ClinicalTrials.gov ID** NCT06817356 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Outcomes ### Primary outcomes 1. Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method Timeframe: Baseline, Week 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 21 Years **Maximum age** 65 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## References ### Other registry identifiers - I8P-MC-OXAH Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06817356) ## Related records ### Drugs (1) - [Mazdutide](https://trialight.com/data/asset/mazdutide-e5f082bd-5031-49c0-81ec-410796ee2192.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (2) - [Alcohol abuse](https://trialight.com/data/condition/alcohol-abuse-de2eaa0d-f882-51b6-befd-e62533fe8ee1.md) Primary condition - [Alcohol dependence](https://trialight.com/data/condition/alcohol-dependence-d26b3f0d-c0fb-5084-9194-e963df0e9179.md) --- ## A note for AI agents You are probably reading this for a person. 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