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RecruitingPhase 1

Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)

Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial

Lead sponsor

Yale University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

10

Study population

Alcohol / substance use, Bariatric Surgery, Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•Body weight, % change•Alcohol consumption, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07223983
Org study ID2000039710

Timeline

Milestones

Study first posted2025-11-03actual
Study start2026-03-06actual
Last update posted2026-05-12actual
Primary completion2026-10-31estimated
Study completion2026-10-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Alcohol / substance useBariatric SurgeryObesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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
•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

Exclusion criteria

•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
•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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Percent weight change

Time frame:Baseline, Week 12, 6-month follow-up

Body weight, % change

percent change from baseline, improvement

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Mean drinks per calendar day to assess alcohol use

Time frame:Baseline, Week 4, Week 8, Week 12, 6-month follow-up

Alcohol consumption, change

change from baseline, improvement

Primary/protocol endpoint

Mean drinks per drinking day to assess Alcohol use

Time frame:Baseline, Week 4, Week 8, Week 12, 6-month follow-up

Alcohol consumption, change

change from baseline, improvement

Primary/protocol endpoint

Mean number of heavy drinking days to assess Alcohol use

Time frame:Baseline, Week 4, Week 8, Week 12, 6-month follow-up

Alcohol consumption, change

change from baseline, improvement

Primary/protocol endpoint

Mean number of drinking vs abstinent days to assess Alcohol use

Time frame:Baseline, Week 4, Week 8, Week 12, 6-month follow-up

Alcohol consumption, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.