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

What Was Tested

The trial (phase 2) is built around Mazdutide.

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.

It had two arms (groups): Mazdutide (experimental) and Placebo (placebo comparator).

Mazdutide administered subcutaneously (SC).

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 308 actual participants took part.

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: Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Mazdutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant and investigator.

It started in 2025-02-06 with completion listed for 2026-03-19.

It ran at 25 sites in United States (25).

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 308 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.