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

NCT07223983 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2000039710
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Percent weight change

  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

  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

  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

  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

  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

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

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 DRUG

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).

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 9 months: 3-month treatment plus 6-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 three 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• Hendershot CS, Bremmer MP, Paladino MB, Kostantinis G, Gilmore TA, Sullivan NR, Tow AC, Dermody SS, Prince MA, Jordan R, McKee SA, Fletcher PJ, Claus ED, Klein KR. Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):395-405. doi: 10.1001/jamapsychiatry.2024.4789.

  PMID: 39937469 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentina Ivezaj, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Ivezaj, PhD

CONTACT

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

Caitlin Smith, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Post-treatment and six-month follow-up assessments will be completed by a study clinician that is blind to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to a medication (Semaglutide) or a wait-list control for three months with a subsequent six-month follow-up (total 9 months).

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 3, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)