Cannabis for Obesity Trial

NCT06137365 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 86131
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Weight change

  measured in kg using digital scale

  weekly for duration of 6-month trial

Study Arms (2)

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.

Drug: Cannabis

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cannabis DRUG

Cannabis gummy product will be prepared using cannabis flower extract.

Active

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Joshua A. Lile, Ph.D.: lead

MeSH Terms

Conditions

Obesity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joshua Lile

CONTACT

8594200503; joshua.a.lile@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only investigator-level study personnel will have access to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Placebo and active cannabis groups

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start (Estimated): June 21, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share