A Phase 1 interventional study of Placebo and Semaglutide 1.0 mg in Alcohol Use Disorder (AUD) and Obesity (BMI Equal to or >30), sponsored by Yale University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Yale University · Phase 1, Interventional, and Other
This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
A randomized, double blind placebo controlled 20 week study of two doses of Semaglutide (SEMA) versus placebo in men and women with AUD and obesity (OB:BMI 30-49.9 kg/m2) will be studied to assess alcohol and food craving and stress in a validated laboratory model as well as examine changes in alcohol intake and related alcohol use outcomes during a 20 week clinical treatment and 8 week post-treatment follow-up phase of the study, in order to test mechanisms by which SEMA may exerts significant effects on alcohol use disorder outcomes.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 90 is close to the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo saline pen administered weekly for 20 weeks
Other: Placebo
Semaglutide low dose of 1.0 mg administered weekly over the 20-weeks trial
Drug: Semaglutide 1.0 mg
Semaglutide high dose 2.0 mg administered weekly over the 20-weeks trial
Drug: Semaglutide 2.0 mg
Placebo - administered one weekly for 20 weeks
Semaglutide 1.0 mg low dose
Semaglutide 2.0 mg high dose
Alcohol use days
Days of alcohol use over 20 weeks of treatment
Time frame: 20 weeks
Heavy drinking days
Days of heavy drinkings (Mne: greater than 5 or more drinks; Women: greater than 4 or more drinks)
Time frame: 20 weeks
Average drinks per drinking day
Average number of alcoholic drinks consumed on a drinking day
Time frame: 20 weeks
Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving
The OCDS is a 14-item self-report tool that measures alcohol craving, obsessive thoughts about drinking, and compulsive drinking behaviors. Total scores and subscale scores range from 0 to 40, with higher scores reflecting more overall craving in each category and total craving.
Time frame: 20 weeks
Food Craving Inventory (FCI) to assess Food craving
The FCI is a 28-item self-report questionnaire assessing the frequency of cravings for specific foods over the past month using a 5-point Likert scale (1 = never to 5 = always/almost every day). Total scores range from 28 to 140, with higher scores reflecting more frequent overall cravings.
Time frame: 20 weeks
Mean change Body weight
Mean changes in body weight (pounds)
Time frame: 20 weeks
Plan to share: Yes — Investigators will follow NIH-NIAAA data sharing plan and upload de-identified individual data including demographics, treatment and outcomes data to the NIMHDataArchives (NDa) as required by NIAAA.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Baseline data will be uploaded twice yearly. Clinical trial outcome data will be shared after study completion and breaking the blind and completion of final analysis of the main study outcomes.
Access criteria: Access will be provided following the NIH-NIAAA guidelines available at https://grants.nih.gov/grants/guide/notice-files/NOT-AA-19-020.html at the URL below.
Data sharing details ↗ · nda.nih.gov
Started Oct 2026 (actual). Primary completion is estimated for Oct 2031, 60 months after the start.
Of 63 non-industry phase 1 interventional studies under Alcoholism, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 60 months is above that.
Counting every sponsor, half of 75 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Semaglutide