Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419374
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-14
Brief Title:
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants with Compensated Cirrhosis Due to MASH
Sponsor:
89bio Inc
Organization:
89bio Inc
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis MASH ENLIGHTEN-Cirrhosis
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:
None
Brief Summary:
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH biopsy-confirmed fibrosis stage F4 MASH previously known as nonalcoholic steatohepatitis NASH
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