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.

Lexaria Bioscience Corp.7 sites in 1 country148 target enrollmentDecember 4, 2024

InterventionsArm 1 - DehydraTECH-CBD alone Arm 2 - DehydraTECH-semaglutide alone Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide Arm 4 - Rybelsus medication (semaglutide) alone Arm 5- Tirzepatide

DrugsArm 1 - DehydraTECH-CBD alone Arm 2 - DehydraTECH-semaglutide alone Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide Arm 4 - Rybelsus medication (semaglutide) alone Arm 5- Tirzepatide

Overview

Phase: Phase 1
Intervention: Arm 1 - DehydraTECH-CBD alone
Conditions: Type2diabetes
Sponsor: Lexaria Bioscience Corp.
Enrollment: 148
Locations: 7
Primary Endpoint: Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 4, 2024

End Date

July 31, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lexaria Bioscience Corp.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function.
•For participants with pre- or Type 2 diabetes: diet controlled or receiving oral anti-diabetic treatment (metformin or other biguanides and/or sulphonylureas) who have received a stable dose for at least 3 months prior to enrollment.
•Glycosylated haemoglobin levels of \> 4.5 but ≤ 10%.
•Have a BMI at Screening of ≥ 27.00 kg/m2 and ≤ 40 kg/m2 .
•Willing to maintain a stable dose of oral anti-diabetic and/or lipid-lowering agents/medications that may have an effect on plasma glucose, insulin or lipid parameters for the duration of the study, where applicable.
•No changes in diet for 4 weeks prior to randomisation (in the opinion of PI or designee), and willing to fast overnight prior to morning dosing during the course of the study. Willing to follow the recommendations for meals and water consumption around the time of each dose administration for the duration of the study (as defined in Section 7.3.3).
•18 to 65 years of age (inclusive at the time of informed consent).
•Clinical laboratory values within normal range or as expected for the patient population or deemed not clinically significant (CS) by the PI or designee. One repeat test at Screening is acceptable for out-of-range CS values following approval by the PI or designee.
•Estimated glomerular filtration rate (eGFR) within the normal range, using the 2021 CKD-EPI equation (\> 60 mL / min / 1.73 m2).
•Females must not be pregnant, planning pregnancy, or lactating, and must use acceptable, highly effective double contraception from Screening until 125 days after the last dose of IP administration. Effective forms of contraception are defined in Section 7.3.

Exclusion Criteria

•A participant who meets any of the following exclusion criteria must be excluded from the study:
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
•Participants with a history of, or currently undergoing treatment for, a thyroid disorder. Participants may still be eligible if they have an additional test confirming that TSH levels are within the normal range (at the discretion of the PI).
•Participant is taking insulin (ie, they are insulin-dependent).
•Taking the following categories of medicines: fibrates, Thiazolidinediones, therapeutic Omega-3 fatty acids (more than 4000 mg/day), alpha-glucosidase inhibitors and unwilling to abstain 2 weeks prior to dosing and for the duration of the study.
•Currently taking a lipid lowering agent and a stable dose has not been maintained for at least 4 weeks prior to randomisation.
•Use of anti-obesity medication within 90 days before enrollment.
•Currently receiving a prohibited medication (Section 7.3.1) and unwilling to stop at the Screening visit and for the duration of the study.
•Currently using an anti-hypertensive, with the exception of anti-hypertensives that are not relevant CYP450 inhibitors/inducers (listed in Table 2).
•Medications that are not on a stable dose, directly prohibited per the protocol and mentioned in IBs as posing a risk for causing Drug-Drug-Interactions (DDIs) taken without the Investigator's review and approval. However, in case of concerns, the Investigator should consult with the Medical Monitor.

Arms & Interventions

Arm 1 - DehydraTECH-CBD alone

Intervention: Arm 1 - DehydraTECH-CBD alone

Arm 2 - DehydraTECH-semaglutide alone

Intervention: Arm 2 - DehydraTECH-semaglutide alone

Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide

Intervention: Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide

Arm 4 - Rybelsus medication (semaglutide) alone as a positive control.

Intervention: Arm 4 - Rybelsus medication (semaglutide) alone

Arm 5- DehydraTECH Tirzepatide

Intervention: Arm 5- Tirzepatide

Outcomes

Primary Outcomes

Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events

Time Frame: Baseline to Day 113 post first dose administration

Secondary Outcomes

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)