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

Sponsor
Lexaria Bioscience Corp.
Study ID
NCT06648031
Phase
PHASE1
Status
Completed

Conditions

  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Arm 1 - DehydraTECH-CBD alone — DRUG
    Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule
  • Arm 2 - DehydraTECH-semaglutide alone — DRUG
    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
  • Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide — DRUG
    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
  • Arm 4 - Rybelsus medication (semaglutide) alone — DRUG
    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
  • Arm 5- Tirzepatide — DRUG
    Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
148 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - DehydraTECH-CBD alone
  • Experimental: Arm 2 - DehydraTECH-semaglutide alone
  • Experimental: Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide
  • Active Comparator: Arm 4 - Rybelsus medication (semaglutide) alone as a positive control.
  • Experimental: Arm 5- DehydraTECH Tirzepatide

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events [ Time Frame: Baseline to Day 113 post first dose administration ]

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