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Tirzepatide for Alcohol Use Disorder
Plain-language guide to NCT06994338: phase 2 randomized trial of Tirzepatide, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06994338
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2025-10-06
- Completion (planned or actual)
- 2026-08-31
- Participants
- 42 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Alcohol Use Disorder; Obesity and Overweight; Alcohol
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Tirzepatide.
It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
42 planned participants were the target.
It was open to people of any sex aged from 21 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms). Body mass index ≥ 27kg/m2. Willingness to attend weekly medication visits and complete all study procedures. Ability to read and communicate in English. Stable housing status.
The full record lists 8 inclusion and 26 exclusion criteria; among the exclusions: meeting past-year dsm-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder); history of chronic or acute pancreatitis; history of suicide attempt or report of current (past 2 weeks) active suicidal ideation.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2025-10-06 with completion listed for 2026-08-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of heavy drinking days (time frame: Last 4 weeks of treatment (Weeks 5-8)).
It also tracked 5 secondary outcomes, for example Drinks per drinking day, WHO drinking risk level, Abstinent days and Absence of heavy drinking.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide in 42 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.