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

NCT06648031 | Completed Phase 1 DMC

• 1 other identifier: GLP-1-H24-4
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 7

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.

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Day 113 post first dose administration

Secondary Outcomes (7)

• 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

Study Arms (5)

Arm 1 - DehydraTECH-CBD alone

EXPERIMENTAL

Drug: Arm 1 - DehydraTECH-CBD alone

Arm 2 - DehydraTECH-semaglutide alone

EXPERIMENTAL

Drug: Arm 2 - DehydraTECH-semaglutide alone

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

Drug: Arm 4 - Rybelsus medication (semaglutide) alone

Arm 5- DehydraTECH Tirzepatide

EXPERIMENTAL

Drug: Arm 5- Tirzepatide

Interventions

Arm 2 - DehydraTECH-semaglutide alone DRUG

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

Arm 2 - DehydraTECH-semaglutide alone

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

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

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

Arm 4 - Rybelsus medication (semaglutide) alone DRUG

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

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

Arm 5- Tirzepatide DRUG

Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks

Arm 5- DehydraTECH Tirzepatide

Arm 1 - DehydraTECH-CBD alone DRUG

Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule

Arm 1 - DehydraTECH-CBD alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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 7.3.2. 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.
• 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.
• Able and willing to attend the necessary visits to the study site and undertake all assessments.
• 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.

You may not qualify if:

• 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.
• Vaccination with a live vaccine within 2 weeks prior to the first administration of IP.
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to Screening or 5-half lives, whichever is longer.
• Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
• Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within 30 days prior to study entry and unwilling to abstain for the duration for the study.
• Current smoker, including cannabis user, and must not have used any tobacco or cannabis products within 30 days prior to Screening and unwilling to abstain for the duration for the study.
• Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol \[THC\], amphetamines, benzodiazepines, opiates, and cocaine), or alcohol breath test, except where a participant has a prescription and diagnosis (eg. ADHD on dexamphetamine, or opioids following an operation, etc.).

Sponsors & Collaborators

• Lexaria Bioscience Corp.: lead

Study Sites (7)

Paratus Clinical Pty Ltd, Blacktown Trial Clinic

Blacktown, New South Wales, 2148, Australia

Location

Emeritus - Sydney

Botany, New South Wales, 2019, Australia

Location

Canopy Clinical Sutherland

Miranda, New South Wales, 2228, Australia

Location

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Paratus Clinical Brisbane Pty Ltd

Herston, Queensland, 4006, Australia

Location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Emeritus - Melbourne

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Interventions

semaglutide; Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 4, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)