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Semaglutide for Alcohol Use Disorder After Bariatric Surgery

This study is looking at whether Semaglutide (an injectable medication) can help adults who have had weight-loss surgery (metabolic and bariatric surgery) and are also struggling with Alcohol Use Disorder. Researchers want to see if Semaglutide is a practical and acceptable treatment for these individuals. You might be able to join if you are 18 or older, have had certain types of weight-loss surgery, and meet specific BMI (Body Mass Index) requirements. The study will measure changes in your alcohol use and weight over time to see if Semaglutide is effective. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive weekly injections of Semaglutide for three months, with doses increasing over time. You would also have follow-up visits for up to six months total.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after the three-month treatment period, for a total of six months.

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NCT07223983

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Yale University
~10 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Semaglutide 1.0 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent weight change
Measured over Baseline, Week 12, 6-month follow-up
+4 more outcomes measured

Conditions

Alcohol Use Disorder
Weight Loss
Bariatric Surgery Patients

Explore related trials

Alcohol use disorderBariatric Surgery PatientsObesity

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Valentina Ivezaj, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Valentina Ivezaj, PhD
[email protected]
203-785-7807
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent weight changeBaseline, 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.

  • Mean drinks per calendar day to assess alcohol useBaseline, Week 4, Week 8, Week 12, 6-month follow-up

    Mean drinks per calendar day will be assessed through timeline follow back interviews

  • Mean drinks per drinking day to assess Alcohol useBaseline, Week 4, Week 8, Week 12, 6-month follow-up

    Mean drinks per drinking day will be assessed through timeline follow back interviews

  • Mean number of heavy drinking days to assess Alcohol useBaseline, Week 4, Week 8, Week 12, 6-month follow-up

    Mean number of heavy drinking days will be assessed through timeline follow back interviews

  • Mean number of drinking vs abstinent days to assess Alcohol useBaseline, 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