Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754373
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2021-02-10
Brief Title:
A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Sponsor:
BIO-CAT Microbials LLC
Organization:
BIO-CAT Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study a lipase -sourced from a nonpyrogenic yeast Candida rugosa will be investigated to establish optimal TG levels in adults in a 12-week supplementation period The investigational product provides a lipase formulation that is stable and active in acidic and neutral pH environments while also fully digesting TGs into free fatty acids and glycerol which is beyond the scope of pancreatic lipase Schuler et al 2012 This will be a novel study investigating the effects of C rugosa lipase on adults with slightly elevated TG levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None