Recruiting
Phase 1

Semaglutide

Sponsor:

Yale University

Code:

NCT07772960

Conditions

Alcohol Use Disorder (AUD)

Obesity (BMI Equal to or >30)

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Not accepted

Interventions

Placebo

Semaglutide 1.0 mg

Semaglutide 2.0 mg

Study Details

Brief summary:

This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.

Conditions

Alcohol Use Disorder (AUD)

Obesity (BMI Equal to or >30)

Study ID

NCT07772960

Start date

Oct 1, 2026

Status verified date

Nov, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Oct 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
  • regular weekly alcohol use (at least 3X/week) prior to admission;
  • must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
  • Good health as verified by screening and physical examination;
  • Able to read English and complete study evaluation;
  • Able to provide informed written and verbal consent.

Exclusion Criteria:

  • Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
  • Current use of opiates;
  • Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c >6.5% and on current medications for T2D treatment;
  • Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;
  • Current use of any anti-obesity medications;
  • Prior history of bariatric surgery or current intragastric balloon;
  • Current participation in structured meal replacement or weight loss program;
  • Weight loss of >=10% over the preceding 6 months;
  • Women who are pregnant, nursing or refuse use of reliable form of birth control.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo saline pen administered weekly for 20 weeks

active comparator: Semaglutide 1.0 mg

Semaglutide low dose of 1.0 mg administered weekly over the 20-weeks trial

active comparator: Semaglutide 2.0 mg

Semaglutide high dose 2.0 mg administered weekly over the 20-weeks trial

Interventions

Placebo

Placebo - administered one weekly for 20 weeks

Semaglutide 1.0 mg

Semaglutide 1.0 mg low dose

Semaglutide 2.0 mg

Semaglutide 2.0 mg high dose

Primary outcome measure

  • Alcohol use days [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

RAJITA SINHA, PHD

2037375805rajita.sinha@yale.edu

Locations

Yale Stress Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Karen Hunkele, BA

888-978-7377karen.hunkele@yale.edu

Yale Stress Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Karen Hunkele, BA

888-978-7377rajita.sinha@yale.edu

More Information

Sponsor

Yale University

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Alcohol Use Disorder
  • alcohol craving
  • Semaglutide
  • food craving
  • alcohol intake

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Yale University on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.