Recruiting
Phase 1

Semaglutide

Sponsor:

Yale University

Code:

NCT07223983

Conditions

Alcohol Use Disorder

Weight Loss

Bariatric Surgery Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide 1.0 mg

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Weight Loss

Bariatric Surgery Patients

Study ID

NCT07223983

Start date

Mar 6, 2026

Status verified date

May, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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).

Primary outcome measure

  • Percent weight change [ Time Frame: 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 drinking day to assess Alcohol use [ Time Frame: 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 drinking vs abstinent days to assess Alcohol use [ Time Frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up ]

Central Contacts and Locations

Central contacts

Valentina Ivezaj, PhD

203-785-7807valentina.ivezaj@yale.edu

Caitlin Smith, PhD

203-785-7210caitlin.smith@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-12.