Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555640
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous Injection of DR10624 in Subjects With Severe Hypertriglyceridemia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor GLP-1Rglucagon receptor GCGR fibroblast growth factor 21 receptor FGF21R agonizing activities The objectives of the planned clinical investigation will be to evaluate the efficacy of DR10624 on fasting serum triglyceride TG levels after 12 weeks of treatment in subjects with severe hypertriglyceridemia SHTG
Detailed Description:
The subjects will be randomly assigned to experimental groups and placebo-controlled groups Each participant will be enrolled in only one cohort
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