Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05872269
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
Sponsor:
Zydus Lifesciences Limited
Organization:
Study Overview
Official Title:
A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)
Status:
RECRUITING
Status Verified Date:
2024-02
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:
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Detailed Description:
The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).
Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Study Oversight
Has Oversight DMC:
True
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?: