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Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

Plain-language guide to NCT05895643: phase 2 randomized trial of Semaglutide, 108 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05895643
Phase
phase 2
Status
completed
Start
2023-06-13
Completion (planned or actual)
2025-07-31
Participants
108 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Alcohol Abuse; Alcohol Addiction; Alcohol Dependence; Alcohol Use Disorder
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Semaglutide.

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI\>30 kg/m2).

Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo.

The medication will be provided as a supplement to standardised cognitive behavioural therapy.

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

Saline s.c. once-weekly.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 108 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Informed oral and written consent. Alcohol use disorder identification test (AUDIT) score \>15. Body mass index (BMI) above or equal to 30 kg/m2. Age 18 - 70 years (both included).

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: A history of delirium tremens or alcohol withdrawal seizures; no serious withdrawal symptoms at inclusion (a score higher than 9 on the clinical institute withdrawal assessment of alcohol scale, revised (ciwa-ar)) at baseline examinations; present or former neurological disease, including traumatic brain injury.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

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, investigator and outcomes assessor.

It started in 2023-06-13 with completion listed for 2025-07-31.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in heavy drinking days (time frame: From baseline to 26 weeks of treatment).

It also tracked 25 secondary outcomes, for example Change in heavy drinking days adjusted for weightloss, Total alcohol consumption, Drinks per day, Days without alcohol consumption, Time to relapse and Time to relapse (heavy drinking day).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 108 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.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

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.