Semaglutide Therapy for Alcohol Reduction (STAR)

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

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

Weekly subcutaneous (s.c.) injections of placebo.

The registry classes the interventions as behavioral and drug.

More on the Plan

This will be a Phase 2a, pilot, proof-of-concept, outpatient study combined with experimental medicine human laboratory procedures.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 18 years up to 110 years.

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

Examples of who could join: At least 18 years old. Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing.

The full record lists 7 inclusion and 21 exclusion criteria; among the exclusions: BMI \< 23 kg/m\^2 or BMI \>= 50 kg/m\^2; evidence of malnutrition as determined by the nutrition risk screening 2002 (nrs-2002); current or prior use of semaglutide or tirzepatide.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-10-17 with completion listed for 2027-03-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Determine the safety and tolerability of semaglutide in individuals with AUD.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 63 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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