Cannabis gummy could help shed pounds, early trial hopes
NCT ID NCT06137365
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This Phase 2 study will test whether a once-daily cannabis gummy can help people with obesity lose weight. Forty adults aged 18–65 with a BMI of 30 or higher will receive either the cannabis gummy or a placebo for a set period. The main goal is to measure changes in body weight.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cannabis gummy (cannabis flower extract)
- What this could lead to
- If it works, this could point toward a new weight-loss option for people with obesity.
- What could go wrong
- This is a small, early-stage trial with only 40 participants. It may not show significant weight loss, and long-term safety is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Kentucky
RECRUITINGLexington, Kentucky, 40517, United States
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