RightFit
Not yet recruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 68 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

CT