Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648031
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief 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
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DehydraTECH
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None