Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT07145151
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Sponsor:
The United Bio-Technology (Hengqin) Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of UBT251 Injection in Adult Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Status:
RECRUITING
Status Verified Date:
2025-08
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:
MASH
Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of UBT251 in MASH subjects. Subjects will be randomly assigned to UBT251 2mg-dose, 4mg-doseļ¼6mg-dose and placebo groups. The entire trial cycle includes a 6-week screening period, a 48-week double-blind treatment period, and a 4-week follow-up period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Approved No.:2023LP01795 | OTHER | National Medical Products Administration | View |