Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
SEMA AUD
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2026
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2031
August 19, 2026
August 1, 2026
5.1 years
August 13, 2026
August 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alcohol use days
Days of alcohol use over 20 weeks of treatment
20 weeks
Secondary Outcomes (3)
Heavy drinking days
20 weeks
Average drinks per drinking day
20 weeks
Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving
20 weeks
Other Outcomes (2)
Food Craving Inventory (FCI) to assess Food craving
20 weeks
Mean change Body weight
20 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo saline pen administered weekly for 20 weeks
Semaglutide 1.0 mg
ACTIVE COMPARATORSemaglutide low dose of 1.0 mg administered weekly over the 20-weeks trial
Semaglutide 2.0 mg
ACTIVE COMPARATORSemaglutide high dose 2.0 mg administered weekly over the 20-weeks trial
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale Stress Center
New Haven, Connecticut, 06519, United States
Related Publications (1)
Harvanek ZM, Milivojevic V, Hart R, Sinha R. Alterations in glucose and insulin resistance following stress and alcohol cues predict alcohol craving in those with AUD and obesity: A preliminary study. Alcohol Clin Exp Res (Hoboken). 2026 May;50(5):e70283. doi: 10.1111/acer.70283.
PMID: 42101823BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajita Sinha
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 19, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 31, 2031
Study Completion (Estimated)
October 31, 2031
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- Baseline data will be uploaded twice yearly. Clinical trial outcome data will be shared after study completion and breaking the blind and completion of final analysis of the main study outcomes.
- Access Criteria
- Access will be provided following the NIH-NIAAA guidelines available at https://grants.nih.gov/grants/guide/notice-files/NOT-AA-19-020.html at the URL below.
Investigators will follow NIH-NIAAA data sharing plan and upload de-identified individual data including demographics, treatment and outcomes data to the NIMHDataArchives (NDa) as required by NIAAA.