ObesityPhase 2NCT06137365
Cannabis for Obesity Trial
A Phase 2 study testing Cannabis in people with Obesity, run by Joshua A. Lile, Ph.D. at 1 site in United States.
Trial summary
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40517
Joshua Lile, PhD, 859-323-6034, jalile2@uky.edu
About this study
Official title: A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.
- Conditions
- Obesity
- Being tested
- Cannabis, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Cannabis gummy product will be prepared using cannabis flower extract.
PlaceboDrug
Placebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 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. Receives: Drug: Cannabis |
| Placebo | Placebo comparator | Placebo cannabis "gummy", containing no active THC, administered once daily for duration of 6-month trial participation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
measured in kg using digital scale
Measured: weekly for duration of 6-month trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Aug 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo and active cannabis groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua A. Lile, Ph.D., University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137365
- Sponsor's protocol ID
- 86131
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals
- ClinicalTrials.gov ID
- NCT06137365
- Acronym / sponsor ID
- 86131
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo and active cannabis groups
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: CannabisCannabis "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 | Placebo comparator | Drug: PlaceboPlacebo cannabis "gummy", containing no active THC, administered once daily for duration of 6-month trial participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisCannabis gummy product will be prepared using cannabis flower extract. | Drug | Active |
| PlaceboPlacebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids. | Drug | Placebo |
Primary outcome
Weight change
Time frame: weekly for duration of 6-month trial
measured in kg using digital scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis in people with Obesity, run by Joshua A. Lile, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Lile (8593236034, jalile2@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: weekly for duration of 6-month trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.