Trial results for semaglutide in alcohol use disorder were posted on ClinicalTrials.gov on 2025-03-24. The Phase 2 study (NCT05520775) showed that participants receiving semaglutide experienced a mean reduction of -32.72 grams in alcohol consumed, compared to -6.95 grams in the sham/placebo group.
Background
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. This trial investigated its effects on alcohol-related outcomes in adults diagnosed with alcohol use disorder (AUD).
Trial design
The study (NCT05520775) was an early Phase 2 human laboratory trial using a randomized, placebo-controlled, dose-ranging design. It enrolled 48 participants diagnosed with alcohol use disorder and cigarette smoking. Participants received either semaglutide or a sham/placebo.
Key results
The trial investigated several alcohol-related outcomes. For the outcome 'Change in Alcohol Consumed':
- Participants in the semaglutide group showed a mean change of -32.72 grams (Standard Deviation: 27.98).
- Participants in the sham/placebo group showed a mean change of -6.95 grams (Standard Deviation: 24.49).
For 'Change in Breath Alcohol Concentration':
- The semaglutide group had a mean change of -0.034 g/dl (Standard Deviation: 0.045).
- The sham/placebo group had a mean change of -0.016 g/dl (Standard Deviation: 0.047).
For 'Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)':
- The semaglutide group showed a mean change of .45 Score on a scale (Standard Deviation: 12.82).
- The sham/placebo group showed a mean change of -1.28 Score on a scale (Standard Deviation: 13.49).
For 'Change in Subjective Sedation (Biphasic Alcohol Effects Scale)':
- The semaglutide group showed a mean change of 0.14 Score on a scale (Standard Deviation: 10.69).
- The sham/placebo group showed a mean change of -3.22 Score on a scale (Standard Deviation: 7.89).
For 'Change in Alcohol Demand (Alcohol Purchase Task)':
- The semaglutide group showed a mean change of -2.91 number of drinks (Standard Deviation: 3.73).
- The sham/placebo group showed a mean change of -2.90 number of drinks (Standard Deviation: 7.82).
For 'Change in Cigarette Demand (Cigarette Purchase Task)':
- The semaglutide group showed a mean change of -2.4 number of cigarettes (Standard Deviation: 2.61).
- The sham/placebo group showed a mean change of -1.20 number of cigarettes (Standard Deviation: 2.17).
What this means
The results suggest that semaglutide may reduce alcohol consumption and breath alcohol concentration in adults with alcohol use disorder compared to placebo. While subjective measures of stimulation, sedation, and alcohol demand showed less distinct differences between groups, a greater reduction in cigarette demand was also observed in the semaglutide group. These early Phase 2 findings warrant further investigation into the potential of semaglutide for treating alcohol use disorder and potentially co-occurring conditions like cigarette smoking.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05520775, titled 'Semaglutide for Alcohol Use Disorder,' were posted on 2025-03-24 on clinicaltrials.gov.