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 | Biotech Hunter

Enrollment

148

Participants

Timeline

Start Date

December 4, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

September 10, 2025

Conditions

Type2diabetes

Interventions

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

Trial Locations (7)

2019

Emeritus - Sydney, Botany

2148

Paratus Clinical Pty Ltd, Blacktown Trial Clinic, Blacktown

2228

Canopy Clinical Sutherland, Miranda

2500

Canopy Clinical Wollongong, Wollongong

3124

Emeritus - Melbourne, Camberwell

4006

Paratus Clinical Brisbane Pty Ltd, Herston

5000

CMAX Clinical Research, Adelaide