Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 … (NCT06648031) | Clinical Trial Compass
CompletedPhase 1
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
Australia148 participantsStarted 2024-12-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
Exclusion criteria
✕. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
What they're measuring
1
Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Timeframe: Baseline to Day 113 post first dose administration
✕. 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).