Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347016
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-29
Brief Title:
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Sponsor:
Arrowhead Pharmaceuticals
Organization:
Arrowhead Pharmaceuticals
Study Overview
Official Title:
Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Plozsiran in Adults With Severe Hypertriglyceridemia
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SHASTA-4
Brief Summary:
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection ARO-APOC3 in adult participants with severe hypertriglyceridemia SHTG After providing informed consent eligible participants will be randomized to receive 4 doses once every 3 months of plozasiran or placebo and be evaluated for efficacy and safety After Month 12 eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509301-80 | EUDRACT_NUMBER | None | None |