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SEMA AUD

RecruitingPhase 1

Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes

Lead sponsor

Yale University

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

2

Estimated enrollment

90

Study population

Alcohol / substance use, Obesity / overweight

Eligibility highlights

•BMI 30-49.9

Primary endpoint

•Alcohol use days

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07772960
Org study ID2000042236
Secondary IDR01AA032779

Timeline

Milestones

Study first posted2026-08-19actual
Study start2026-10-01actual
Last update posted2026-11-04actual
Primary completion2031-10-31estimated
Study completion2031-10-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Alcohol / substance useObesity / overweight

Who can enroll

Minimum age18 Years
Maximum age68 Years
SexAll
Healthy volunteersNot 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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Weight & body composition
1

Weight & body composition

1 endpoint
Other/protocol endpoint

Mean change Body weight

Time frame:20 weeks

change from baseline, improvement

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Alcohol use days

Time frame:20 weeks

descriptive

Secondary/protocol endpoint/low confidence

Heavy drinking days

Time frame:20 weeks

descriptive

Secondary/protocol endpoint/low confidence

Average drinks per drinking day

Time frame:20 weeks

descriptive

Secondary/protocol endpoint/low confidence

Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving

Time frame:20 weeks

descriptive

Other/protocol endpoint/low confidence

Food Craving Inventory (FCI) to assess Food craving

Time frame:20 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.