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Tirzepatide

Mounjaro, Zepbound, LY3298176

Quick Stats
Studies 183
Trials 100
Active Not Recruiting PHASE1 INTERVENTIONAL 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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

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

Primary Outcomes

Measure: Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
TimeFrame: Baseline to Day 113 post first dose administration
Description:

Trial Information

NCT ID

NCT06648031

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Lexaria Bioscience Corp.

Last Updated

December 15, 2025