Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594523
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2F3 Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis MASH and F2F3 Fibrosis FASCINATE-3
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:
FASCINATE-3
Brief Summary:
A randomized double-blind placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective as compared to placebo in resolving MASH without the worsening of fibrosis andor in fibrosis regression without the worsening of steatohepatitis
Detailed Description:
Approximately 1260 patients including at least 60 of F3 patients will be enrolled to receive either denifanstat 50 mg 580 patients placebo 580 patients or denifanstat 25 mg 100 patients
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