Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

What Was Tested

The trial (phase 2) is built around Semaglutide.

This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD.

Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

Participants in this Arm will study medication for a total of 8 weeks - on semaglutide a set amount for 4 weeks, then a set amount for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

The registry classes the interventions as drug.

More on the Plan

A screening visit will be conducted at which written informed consent will be obtained and inclusion/exclusion criteria will be assessed.

Participants will complete 7 additional clinic visits (weekly during the first 4 weeks of the treatment period and biweekly during the second 4 weeks).

At each visit, participants will also engage in a computerized behavioral intervention.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 21 or older. Has a body mass index (BMI) of at least 25 kg/m2. Able to read and understand questionnaires and informed consent. Lives within 50 miles of the study site.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: current dsm-5 diagnosis of any other substance use disorder of moderate or greater severity, except for nicotine use disorder, as assessed by mini; urine drug screen at screening positive for any substance except cannabis; current dsm-5 bipolar disorder, major depressive episode, or panic disorder, as assessed by mini.

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-01-11 with completion listed for 2025-11-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Cue Craving Visual Analog Score (time frame: 7 weeks - change between screening and Week 6 visit).

It also tracked 3 secondary outcomes, for example Number of drinks per day and Percentage of heavy drinking days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 50 people.

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

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