Recruiting
Phase 2

Cannabis

Sponsor:

Joshua A. Lile, Ph.D.

Code:

NCT06137365

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Cannabis

Placebo

Study Details

Brief summary:

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

Conditions

Obesity

Study ID

NCT06137365

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Lab-Screening Exclusion:

  • Thyroid-stimulating hormone (TSH) level outside of the normal range, confirmed on repeat testing
  • AST, ALT, or alkaline phosphatase >2x ULN
  • EGFR <60 ml/min as calculated using the Cockroft-Gault equation.
  • History of significant hypersensitivity, intolerance, or allergy to a cannabinoid or "gummy" product.
  • Current use of any medications or supplement which would either compromise the validity of the study or the safety of the participant.
  • History of seizure or predisposing factors for seizure (head trauma resulting in unconsciousness in past six months or CNS tumors).
  • Meeting the following criteria from the Columbia Suicide Severity Rating Scale (C-SSRS):

  • "yes" to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or
  • "yes" to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) or
  • "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) and
  • the ideation or behavior occurred within the past month.
  • Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in an investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

Cannabis "gummy", starting at 5 mg THC and increased every three weeks by 5 mg increments up to a maximum target dose of 15 mg THC, administered once daily for duration of 6-month trial participation.

placebo comparator: Placebo

Placebo cannabis "gummy", containing no active THC, administered once daily for duration of 6-month trial participation.

Interventions

Cannabis

Cannabis gummy product will be prepared using cannabis flower extract.

Placebo

Placebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.

Primary outcome measure

  • Weight change [ Time Frame: weekly for duration of 6-month trial ]

Central Contacts and Locations

Central contacts

Joshua Lile

8593236034jalile2@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40517

Contacts

Joshua Lile, PhD

859-323-6034jalile2@uky.edu

More Information

Sponsor

Joshua A. Lile, Ph.D.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joshua A. Lile, Ph.D. on 2026-08-07.