Cannabis for Obesity Trial

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.

Key facts

Study ID

NCT06137365

Run by

Joshua A. Lile, Ph.D.

People needed

40

Starts

2026-08-05

Expected to finish

2028-03-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female.
• Age 18-65 years.
• BMI >=30 kg/m2 (i.e., obese).
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by one of the MD study personnel.
• Able to speak and read English.
• Apple or Android phone, or Android tablet with wi-fi or cellular service.
• Vital signs at Screening and Check-in as per the following ranges and stable (measured in a supine position after a minimum of 5 minutes of rest):
• Systolic blood pressure ≥ 90 and ≤ 140 mmHg
• Diastolic blood pressure ≥ 50 and ≤ 90 mmHg
• Pulse rate ≥ 50 and ≤ 100 bpm

You may not qualify if…

• UK Students cannot participant
• Current cannabis use (e.g., past month; negative test for cannabinoids during screening) and no more than 15 self-reported lifetime uses.
• Self-reported current use of CBD.
• Severe past negative experience with cannabis or cannabinoid use (e.g., panic attack, anxiety).
• Use of any anti-obesity medication in the past 90 days. Specifically GLP-1 agonists (e.g., liraglutide, semaglutide, tirzepatide), SGLT-2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin, ertugliflozin), sulfonylureas (e.g., glimepiride, glipizide), medlitinides (e.g., repaglinide, nateglinide), Contrave, phentermine (alone or combination product such as Qsymia) or Orlistat. Stable use of metformin is permitted.
• Current treatment with insulin.
• History of type 1 diabetes.
• Stable body weight over the past 3 months. No changes greater than 5 kg.
• History of stomach or intestinal surgery or resection for obesity or otherwise (such as gastric bypass, sleeve-gastrectomy, bowel or small bowel resection) that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair > 6 months prior to Screening will be allowed).
• Obesity secondary to a known genetic, endocrine, or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing's syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome)
• Moderate or Severe Substance Use Disorder according to DSM-5 criteria; urine test positive for recent use of an abused drug.
• History of significant psychiatric disorder (e.g., bipolar, schizophrenia, depression, history of panic attacks).
• Current use of psychiatric medications (e.g., antipsychotics, antidepressants, anxiolytics).
• Current use of medications associated with hemodynamic instability (e.g., amphetamines, other sympathomimetic agents, atropine, scopolamine, other anticholinergic agents).
• Current use of medications that are inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) or CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).
• A score of 15 or more on the Patient Health Questionnaire (PHQ-9).
• Current or past year history of one or more of the following disorders associated with overeating: rumination disorder, bulimia nervosa, severe/extreme binge eating disorder (>7 episodes per week) or other specified/unspecified feeding/eating disorder that would increase risk to the participant or complicate interpretation of the data. Individuals who report mild to moderate (<7 episodes per week) binge eating disorder are eligible.
• Female participant who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
• Male participant who is not using a highly effective contraceptive method or who has a female partner who is not using a highly effective contraceptive method.
• Any clinically important uncontrolled illness, medical/surgical procedure, or major trauma within 8 weeks prior to dose administration on Day 1.
• History of congestive heart failure or arrhythmias.
• Any of the following cardiovascular events in the past 3 months
• acute myocardial infarction
• cerebrovascular accident (stroke)
• unstable angina

Where it is running

• University of Kentucky — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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