RecruitingPhase 1NCT07223983

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

Sponsor

Yale University

Enrollment

10 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Weight Loss Alcohol Use Disorder Bariatric Surgery Patients

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria18

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

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Interventions

DRUGSemaglutide 1.0 mg

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).