First randomized trial of tirzepatide for alcohol use disorder begins enrolling

A phase 2 clinical trial testing tirzepatide as a treatment for alcohol use disorder has begun enrolling participants at the University of Southern California, according to its listing on ClinicalTrials.gov ^[1]. The study, funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is registered under identifier NCT06994338 ^[1].

The trial plans to enroll 42 adults who have both alcohol use disorder and overweight or obesity ^[1]. Researchers will track heavy drinking days as the primary outcome, a standard measure in alcohol treatment research that counts days when a person consumes an amount of alcohol above a defined threshold ^[1]. The estimated completion date for the study is August 2026 ^[1].

Tirzepatide is the active ingredient in Mounjaro, approved for type 2 diabetes, and Zepbound, approved for chronic weight management. It is not approved by the Food and Drug Administration for alcohol use disorder, and this trial is testing an unapproved, off-label use of the drug ^[1].

The registration record does not specify whether the trial is placebo-controlled, what dose or doses of tirzepatide will be used, or how long participants will be treated. Those design details are not available in the source reviewed for this story.

Why it matters for patients

Interest in GLP-1 and dual GLP-1/GIP drugs for uses beyond diabetes and weight loss has grown quickly, and alcohol use disorder is one area researchers are actively studying. This trial is a randomized study, which is considered a more rigorous way to test whether a drug actually works compared with observational reports or anecdotes.

For patients who already take tirzepatide for diabetes or weight loss and also drink alcohol heavily, this trial does not change anything about the drug's approved uses or its safety profile. Nothing in the source reviewed states that tirzepatide is safe or effective for alcohol use disorder. The drug remains approved only for type 2 diabetes and chronic weight management under the brand names Mounjaro and Zepbound.

People considering off-label use of tirzepatide or any GLP-1 medication for a condition it is not approved to treat should understand that the evidence is still being generated. With only 42 participants planned, this trial is small and is designed to gather early evidence rather than to prove a treatment effect definitively. Larger studies would likely be needed before any conclusions could support wider use.

What happens next

The trial's estimated completion date is August 2026 ^[1]. Results are not expected before then, and it is not yet known when data might be published or presented after the trial concludes. Because this is an early-phase study, any positive results would likely need to be confirmed in larger, later-phase trials before tirzepatide could be considered for FDA review as a treatment for alcohol use disorder. No such larger trial has been announced in the source reviewed for this story.