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

May 7, 2026 updated by: Yale University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide
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.
Drug: Semaglutide 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).
No Intervention: Wait-list control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent weight change
Time Frame: Baseline, Week 12, 6-month follow-up
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Baseline, Week 12, 6-month follow-up
Mean drinks per calendar day to assess alcohol use
Time Frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per calendar day will be assessed through timeline follow back interviews
Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day to assess Alcohol use
Time Frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day will be assessed through timeline follow back interviews
Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days to assess Alcohol use
Time Frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days to assess Alcohol use
Time Frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews
Baseline, Week 4, Week 8, Week 12, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Valentina Ivezaj, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

October 30, 2025

First Submitted That Met QC Criteria

October 30, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000039710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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