Change in Alcohol Consumed
| Group | Value (grams) | Spread |
|---|---|---|
| Semaglutide | -32.72 | 27.98 |
| Sham/Placebo | -6.95 | 24.49 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).
Experimental
Semaglutide
Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.
Sham comparator
Sham/Placebo
Participants will receive sham subcutaneous injections over 9 weeks.
Outcomes the sponsor listed as primary.
Change in Alcohol Consumed
Time frame · Baseline (Week 0) to post-medication (Week 8)
Estimated grams of ethanol consumed.
Change in Breath Alcohol Concentration
Time frame · Baseline (Week 0) to post-medication (Week 8)
Peak breath alcohol concentration following an alcohol self-administration procedure.
Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)
Time frame · Baseline (Week 0) to post-treatment (Week 8)
Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being "not at all" and 10 being "extremely". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.
Change in Subjective Sedation (Biphasic Alcohol Effects Scale)
Time frame · baseline (Week 0) to post-medication (Week 8)
Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 "not at all" through 10 "extremely". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.
Change in Alcohol Demand (Alcohol Purchase Task)
Time frame · Baseline (Week 0) to post-treatment (Week 8)
The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.
Change in Cigarette Demand (Cigarette Purchase Task)
Time frame · Baseline (Week 0) to Post-medication (Week 8)
Self-report cigarette demand as measured by the Cigarette Purchase Task. Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.
Change in Daily Alcohol Use
Time frame · baseline (Week 0) to study endpoint (Week 10)
Self-reported drinks per day averaged across study week.
Change in Daily Cigarette Use
Time frame · baseline (Week 0) to study endpoint (Week 10)
Self-reported cigarettes per day
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (grams) | Spread |
|---|---|---|
| Semaglutide | -32.72 | 27.98 |
| Sham/Placebo | -6.95 | 24.49 |
| Group | Value (g/dl) | Spread |
|---|---|---|
| Semaglutide | -0.034 | 0.045 |
| Sham/Placebo | -0.016 | 0.047 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Semaglutide | .45 | 12.82 |
| Sham/Placebo | -1.28 | 13.49 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Semaglutide | 0.14 | 10.69 |
| Sham/Placebo | -3.22 | 7.89 |
| Group | Value (number of drinks) | Spread |
|---|---|---|
| Semaglutide | -2.91 | 3.73 |
| Sham/Placebo | -2.90 | 7.82 |
| Group | Value (number of cigarettes) | Spread |
|---|---|---|
| Semaglutide | -2.4 | 2.61 |
| Sham/Placebo | -1.20 | 2.17 |
| Group | Value (daily drinks) | Spread |
|---|---|---|
| Semaglutide | -1.43 | 1.51 |
| Sham/Placebo | -0.81 | 2.45 |
| Group | Value (daily cigarettes) | Spread |
|---|---|---|
| Semaglutide | -2.48 | 4.22 |
| Sham/Placebo | -1.30 | 2.10 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SemaglutideParticipants will receive semaglutide via subcutaneous injections at escalating doses (0.25 mg to 1.0 mg) over 9 weeks. Semaglutide: Semaglutide (subcutaneous) | 0 / 24 | 0 / 24 | 22 / 24 |
| Sham/PlaceboParticipants will receive sham subcutaneous injections over 9 weeks. Sham/placebo: Sham subcutaneous injection | 0 / 24 | 0 / 24 | 18 / 24 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2025
Hendershot et al. 2025JAMA psychiatrycited by 213
PMID 39937469PMC11822619DOI 10.1001/jamapsychiatry.2024.4789PUB-39937469
Who could join, as posted.
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