Type2diabetes
Conditions
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
DRUGArm 1 - DehydraTECH-CBD alone
Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule
DRUGArm 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
DRUGArm 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
DRUGArm 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
DRUGArm 5- Tirzepatide
Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks
Sponsors
Lexaria Bioscience Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically diagnosed as overweight or obese, with or without pre- or Type 2 diabetes with residual islet cell function. 2. 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. 3. Glycosylated haemoglobin levels of \> 4.5 but ≤ 10%. 4. Have a BMI at Screening of ≥ 27.00 kg/m2 and ≤ 40 kg/m2 . 5. 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. 6. 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). 7. 18 to 65 years of age (inclusive at the time of informed consent). 8. 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. 9. Estimated glomerular filtration rate (eGFR) within the normal range, using the 2021 CKD-EPI equation (\> 60 mL / min / 1.73 m2). 10. 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 7.3.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for ≥12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants). Females must not donate ova from the first dose of IP until at least 125 days after the last dose of IP. 11. Males must be surgically sterile (\> 30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal ligation, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method (see Section 7.3.2) must be used from Screening until study completion, including the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 125 days after the last dose of IP. 12. Able and willing to attend the necessary visits to the study site and undertake all assessments. 13. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Exclusion criteria
A participant who meets any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events | Baseline to Day 113 post first dose administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 abnormal laboratory parameters from baseline to end of study (EOS) | 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 |
| Number of participants with change in inflammation (hsCRP)from baseline | Baseline to Day 113 post first dose administration |
Countries
Australia
Outcome results
None listed