NCT06648031

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants

A Phase 1B, Randomized, Open-label, Active-controlled, Parallel, Multiple-dose Study Comparing the Safety, Pharmacokinetics and Efficacy of Dehydratech Cannabidiol and Glucagon-like Peptide 1 Agonists Alone and in Combination, in Overweight or Obese, pre-and Type 2 Diabetic Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Lexaria Bioscience Corp. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, randomized, open-label, active-controlled, parallel, multiple-dose study comparing the safety, pharmacokinetics and efficacy of DehydraTECH Cannabidiol and Glucagon-like Peptide 1 (GLP-1) agonists alone and in combination, in overweight or obese, pre- and type 2 diabetic participants.

Detailed description

The study duration is for a maximum study duration of 20 weeks and 6 days. All participants will be randomized to receive one of the 4 interventions- Arm 1- DehydraTECH-CBD alone; Arm2- DehydraTECH-semaglutide alone; Arm-3 DehydraTECH-CBD in combination with DehydraTECH-semaglutide or Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. Arm 5- DehydraTECH Tirzepatide Treatment period visits include safety assessments, including vital signs and physical examinations (symptom directed), as well as Patient reported outcome (PRO) questionnaires, body mass measures and a 15 to 20 mL blood sample.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
DRUG	Arm 1 - DehydraTECH-CBD alone	Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule
DRUG	Arm 2 - DehydraTECH-semaglutide alone	Dose: 3.5 mg once daily for 4 weeks, ascending to 7 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
DRUG	Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide	DehydraTECH-CBD dosing = 250 mg twice daily for 12 weeks. \- DehydraTECH-semaglutide = 3.5 mg once daily for 12 weeks Route of administration: Oral Dosage form: Capsule
DRUG	Arm 4 - Rybelsus medication (semaglutide) alone	Normal clinical dose of 3.0 mg once daily for 4 weeks, ascending to 7.0 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
DRUG	Arm 5- Tirzepatide	Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-10-18
• Last updated: 2026-01-12

Locations

7 sites across 1 country: Australia