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
- Conditions
- Type2diabetes
- Interventions
- Drug: Arm 1 - DehydraTECH-CBD aloneDrug: Arm 2 - DehydraTECH-semaglutide aloneDrug: Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutideDrug: Arm 4 - Rybelsus medication (semaglutide) aloneDrug: Arm 5- Tirzepatide
- Registration Number
- NCT06648031
- Lead Sponsor
- Lexaria Bioscience Corp.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 - DehydraTECH-CBD alone Arm 1 - DehydraTECH-CBD alone - Arm 2 - DehydraTECH-semaglutide alone Arm 2 - DehydraTECH-semaglutide alone - Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide - Arm 4 - Rybelsus medication (semaglutide) alone as a positive control. Arm 4 - Rybelsus medication (semaglutide) alone - Arm 5- DehydraTECH Tirzepatide Arm 5- Tirzepatide -
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events Baseline to Day 113 post first dose administration
- Secondary Outcome Measures
Name Time Method Number of participants with abnormal laboratory parameters from baseline to end of study (EOS) Baseline to Day 113 post first dose administration Number of participants who have a magnitude of decrease in HbA1c (1% or greater) and/or bodyweight (5% or greater) from baseline. Baseline to Day 113 post first dose administration Number of participants with change in fasting glucose from baseline Baseline to Day 113 post first dose administration Number of participants with change in insulin cholesterol levels from baseline Baseline to Day 113 post first dose administration Number of participants with change in inflammation (hsCRP)from baseline Baseline to Day 113 post first dose administration Number of participants with change in estimated glomerular filtration rate from baseline Baseline to Day 113 post first dose administration Number of participants with change in liver enzymes from baseline Baseline to Day 113 post first dose administration
Trial Locations
- Locations (7)
Paratus Clinical Pty Ltd, Blacktown Trial Clinic
🇦🇺Blacktown, New South Wales, Australia
Emeritus - Sydney
🇦🇺Botany, New South Wales, Australia
Sutherland Shire Clinical Research (SSCR)
🇦🇺Miranda, New South Wales, Australia
Paratus Clinical Brisbane Pty Ltd
🇦🇺Herston, Queensland, Australia
Wollongong Clinical Research (WOCR)
🇦🇺Wollongong, New South Wales, Australia
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia
Emeritus - Melbourne
🇦🇺Camberwell, Victoria, Australia