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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06648031




Registration number
NCT06648031
Ethics application status
Date submitted
16/10/2024
Date registered
18/10/2024

Titles & IDs
Public title
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
Scientific title
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.
Secondary ID [1] 0 0
GLP-1-H24-4
Universal Trial Number (UTN)
Trial acronym
DehydraTECH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type2diabetes 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Arm 1 - DehydraTECH-CBD alone
Treatment: Drugs - Arm 2 - DehydraTECH-semaglutide alone
Treatment: Drugs - Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide
Treatment: Drugs - Arm 4 - Rybelsus medication (semaglutide) alone

Experimental: Arm 1 - DehydraTECH-CBD alone -

Experimental: Arm 2 - DehydraTECH-semaglutide alone -

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

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


Treatment: Drugs: Arm 1 - DehydraTECH-CBD alone
Dose: 250 mg CBD twice daily (500 mg/day) for 12 weeks. Route of administration: Oral Dosage form: Capsule

Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) and Serious adverse events
Timepoint [1] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [1] 0 0
Number of participants with abnormal laboratory parameters from baseline to end of study (EOS)
Timepoint [1] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [2] 0 0
Number of participants who have a magnitude of decrease in HbA1c (1% or greater) and/or bodyweight (5% or greater) from baseline.
Timepoint [2] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [3] 0 0
Number of participants with change in fasting glucose from baseline
Timepoint [3] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [4] 0 0
Number of participants with change in insulin cholesterol levels from baseline
Timepoint [4] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [5] 0 0
Number of participants with change in inflammation (hsCRP)from baseline
Timepoint [5] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [6] 0 0
Number of participants with change in estimated glomerular filtration rate from baseline
Timepoint [6] 0 0
Baseline to Day 113 post first dose administration
Secondary outcome [7] 0 0
Number of participants with change in liver enzymes from baseline
Timepoint [7] 0 0
Baseline to Day 113 post first dose administration

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Clinically diagnosed as overweight or obese, or with 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 > 5.7 but = 10%.
4. Have a Body Mass Index = 30.0 kg/m2 at Screening, or = 27.0 kg/m2 if in the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnoea or cardiovascular disease.
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 Principal Investigator [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 study completion, including the Follow-up period. 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 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

A participant who meets any of the following exclusion criteria must be excluded from the study:

1. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
2. 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).
3. Participant is taking insulin (ie, they are insulin-dependent).
4. Taking the following categories of medicines: fibrates, Thiazolidinediones, therapeutic Omega-3 fatty acids, alpha-glucosidase inhibitors and unwilling to abstain 2 weeks prior to dosing and for the duration of the study.
5. Currently taking a lipid lowering agent and a stable dose has not been maintained for at least 4 weeks prior to randomisation.
6. Use of anti-obesity medication within 90 days before enrollment.
7. Currently receiving a prohibited medication (Section 7.3.1) and unwilling to stop at the Screening visit and for the duration of the study.
8. Currently using an anti-hypertensive, with the exception of anti-hypertensives that are not relevant CYP450 inhibitors/inducers (listed in Table 2Table 2).
9. Intake of prescription drugs (except for stable doses of certain medications for diabetes, cholesterol, cardiovascular disease, or hormonal contraception) or any over-the-counter medications, herbal remedies, supplements, or vitamins 2 weeks before dosing and during the study without the approval of the study's Principal Investigator (PI) or designee and Medical Monitor (MM). Simple pain relief like paracetamol or NSAIDs may be allowed at the Investigator's discretion.
10. Vaccination with a live vaccine within 2 weeks prior to the first administration of IP.
11. 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.
12. 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.
13. 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.
14. Current smoker, including cannabis user, and must not have used any tobacco or cannabis products within 30 days prior to Screening.
15. 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. attention deficit hyperactivity disorder (ADHD) on dexamphetamine, or opioids following an operation, etc.).
16. Known or suspected history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration).
17. Regular alcohol consumption defined as > 10 standard drinks per week (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or > 4 standard drinks on any single day. Participant is unwilling to abstain from alcohol beginning 48 hours prior to Screening, the first administration of IP, and each subsequent visit.
18. A history of chronic pancreatitis, and/or acute pancreatitis within 180 days before randomisation.
19. Previous surgical obesity treatment.
20. Any known or suspected history of epilepsy or recurrent seizures.
21. Use of antidepressants within 3 months prior to randomisation, or depression that is likely to necessitate treatment with antidepressants during the study period and for 60 days after last IP administration, in the opinion of the PI or designee.
22. Participant who has significant history of anxiety, suicidal ideation or self-harm, in the opinion of the PI or designee.
23. Clinically significant cardiac, renal or hepatic impairment in the opinion of PI or designee. For hepatic impairment, specifically excluding participants who have moderate (Child-Pugh B) or severe (Child-Pugh C) liver disease.
24. Genetic dyslipidemic condition in the opinion of PI or designee.
25. Participants who would otherwise be eligible by BMI, but by subjective visual assessment are considered likely to have high muscle and low-fat body composition (eg, body builders or strength sport athletes) in the opinion of the PI or designee.
26. Body weight > 150kg, and/or BMI = 40 kg/m2.
27. Any abnormalities identified during the physical exam that in the opinion of PI or designee, would prevent the participant from safe participation in the study.
28. Blood donation or significant blood loss within 60 days prior to the first administration of IP, or plasma donation within 7 days prior to the first administration of IP, and/or unwilling to abstain from donation of blood during the study.
29. History of severe allergic or anaphylactic reactions that in the opinion of the PI or designee might prevent the participant from safely participating in the study, or sensitivity to the IP or its constituents.
30. History of malignancy, except for non-melanoma skin cancer, excised less than 2 years prior to Screening and cervical intraepithelial neoplasia that has been successfully cured less than 5 years prior to Screening.
31. History or presence of a condition associated with significant immunosuppression.
32. History of life-threatening infection (eg, meningitis) within the past 5 years which may indicate risk to the participant at the discretion of the Investigator.
33. Infections requiring parenteral antibiotics within 6 months prior to Screening.
34. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
35. Systolic blood pressure of <100 mmHg or =180 mmHg and/or diastolic blood pressure of <80 80 mmHg or =120 mmHg, which in the opinion of the PI or designee may pose undue risk to the subject, or symptomatic uncontrolled hypotension or hypertension in the opinion of the PI or designee.
36. Moderate to severe daytime somnolence or daytime sleep disorders (e.g., narcolepsy).
37. Abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant.
38. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Screening. One repeat test at Screening is acceptable for out-of-range values following approval by the PI or designee.
39. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
40. Poor pill swallowing ability.
41. Unwilling to refrain from strenuous exercise (including weightlifting) from 24 hours prior to each visit to the study site.
42. Travel outside the country of residence planned during the study.
43. Any other significant disease or disorder, physical or psychological, or surgery (within the past 3 months prior to Screening) which, in the opinion of PI or designee, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to comply with the protocol or complete the study per protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Pty Ltd, Blacktown Trial Clinic - Blacktown
Recruitment hospital [2] 0 0
Emeritus - Sydney - Botany
Recruitment hospital [3] 0 0
Sutherland Shire Clinical Research (SSCR) - Miranda
Recruitment hospital [4] 0 0
Wollongong Clinical Research (WOCR) - Wollongong
Recruitment hospital [5] 0 0
Paratus Clinical Brisbane Pty Ltd - Herston
Recruitment hospital [6] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [7] 0 0
Emeritus - Melbourne - Camberwell
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lexaria Bioscience Corp.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Janice Henrichs
Address 0 0
Country 0 0
Phone 0 0
+61 03 9824 5254
Fax 0 0
Email 0 0
jhenrichs@acclime.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06648031