Alcohol Use DisorderPhase 1NCT07223983
Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
A Phase 1 study testing Semaglutide 1.0 mg in people with Alcohol Use Disorder and Weight Loss, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Weight Loss, Bariatric Surgery Patients
- What is being tested?
- Semaglutide 1.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study (up to 6 months: 3-month treatment plus 3-month follow up)
- Age 18 and older
- Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past seven years
- Meet current DSM-5 criteria for Alcohol Use Disorder
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- Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators
- Read, comprehend, and write English at a sufficient level to complete study-related materials
- For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation
Who cannot join
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening
- History or presence of chronic or recurrent pancreatitis
- History of malignant neoplasms within the past 5 years prior to screening
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- Is currently using other medications for weight loss or other GLP-1 receptor agonists
- Has a history of allergy or sensitivity to Semaglutide
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- Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute
- Has current uncontrolled hypertension
- Has current uncontrolled Type I or Type II diabetes mellitus
- Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit
- Has active gallbladder disease
- Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder
- Has a recent history of substance use disorder (with the exception of cannabis or tobacco use disorder) within the past 12 months
- Is currently engaging in other treatment for Alcohol Use Disorder or making intentional efforts to quit alcohol use
- Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device
- Is breast-feeding, pregnant, or not using a reliable form of birth control
- Reports active suicidal or homicidal ideation
- Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria which, in the investigator's opinion, might have jeopardized the participant's safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
Read the detailed description
This study aims to evaluate the feasibility and acceptability of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight/obesity. This study will also examine changes in alcohol use disorder and weight. It is hypothesized that the treatment will be feasible and acceptable to participants, and result in reductions in alcohol use and weight.
A recently published randomized controlled trial provided preliminary evidence that Semaglutide can reduce some alcohol craving and drinking outcomes; however, this has not been examined in individuals with a history of bariatric surgery who are at increased risk of alcohol misuse and Alcohol Use Disorder.
- Being tested
- Semaglutide 1.0 mg
- Medical subject headings
- Alcoholism, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 1.0 mgDrug
Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month (three months total).
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month. Participants will be on Semaglutide for three months total. Receives: Drug: Semaglutide 1.0 mg |
| Wait-list control | No intervention | Participants randomized to wait-list control will be followed for three months but no treatment will be administered. At the conclusion of the study, participants in the wait list control group will be offered a three-month behavioral intervention to treat Alcohol Use Disorder, although this is not required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Measured: Baseline, Week 12, 6-month follow-up
Mean drinks per calendar day to assess alcohol use
Mean drinks per calendar day will be assessed through timeline follow back interviews
Measured: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day to assess Alcohol use
Mean drinks per drinking day will be assessed through timeline follow back interviews
Measured: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days to assess Alcohol use
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Measured: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days to assess Alcohol use
Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews
Measured: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start26 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to a medication (Semaglutide) or a wait-list control for three months with a subsequent three-month follow-up (total 6 months).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina Ivezaj, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223983
- Sponsor's protocol ID
- 2000039710
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hendershot CS, Bremmer MP, Paladino MB, Kostantinis G, Gilmore TA, Sullivan NR, Tow AC, Dermody SS, Prince MA, Jordan R, McKee SA, Fletcher PJ, Claus ED, Klein KR. Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):395-405. doi: 10.1001/jamapsychiatry.2024.4789.
PubMed 39937469