This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
Phase
PHASE2
Enrollment
40 (ESTIMATED)
Start date
2026-08-05
Sponsor
Joshua A. Lile, Ph.D.
Design
RANDOMIZED · PARALLEL · TREATMENT
Locations
1
Results record
Not present in registry snapshot
Obesity
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUG
Cannabis
Cannabis gummy product will be prepared using cannabis flower extract.
DRUG
Placebo
Placebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.
Eligibility
Population and criteria
Sex
ALL
Minimum age
18 Years
Maximum age
65 Years
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)
primary outcomes
primary measures
Weight change
Time frame: weekly for duration of 6-month trial
measured in kg using digital scale
Publications
Locally readable linked articles
0
No exact PMID-linked public article is currently readable locally.
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.