NCT07772960 Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
| NCT ID | NCT07772960 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2031-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2026-10-01 with a primary completion date of 2031-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rajita Sinha
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07772960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 68 Years, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07772960 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07772960 currently recruiting?
Yes, NCT07772960 is actively recruiting participants. Contact the research team at rajita.sinha@yale.edu for enrollment information.
Where is the NCT07772960 trial being conducted?
This trial is being conducted at New Haven, United States, New Haven, United States.
Who is sponsoring the NCT07772960 clinical trial?
NCT07772960 is sponsored by Yale University. The principal investigator is Rajita Sinha at Yale University. The trial plans to enroll 90 participants.