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Saroglitazar 4 mg in NAFLD with Comorbidities
NCT05872269Phase 4
Key facts
- Status
- Recruiting
- Start
- Jul 2023
- Primary completion
- Jan 2025
- Countries
- 1
- Sponsor
- Zydus Lifesciences Limited
- Modality
- Small Molecules
- Drugs
- saroglitazar
- Conditions
- non-alcoholic fatty liver disease (NAFLD)
01
Overview
Phase 4, open-label, single-arm trial of saroglitazar in non-alcoholic fatty liver disease (NAFLD), sponsored by Zydus Lifesciences Limited. Primary endpoints: Change in liver stiffness at 52 weeks and Frequency and severity of treatment-emergent adverse events and serious adverse events at 52 weeks. Started Jul 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Saroglitazar 4 mg
Saroglitazar 4 mg oral tablet once daily
03
Who it enrols
Adult patients with a documented diagnosis of NAFLD and at least one comorbidity (obesity, type 2 diabetes, dyslipidemia, or metabolic syndrome) who have been prescribed Saroglitazar. Patients must have elevated liver stiffness (>= 8 kPa) or ALT (>= 45 U/L). Patients with cirrhosis or heavy alcohol consumption are excluded.
04
Endpoints
Primary
Change in liver stiffness
Frequency and severity of treatment-emergent adverse events and serious adverse events
Secondary
Change in TG, HDL-C, LDL-C and non HDL-C levels
Change in serum ALT value
Change in serum AST value
Change in serum ALP value
Change in body weight
Change in BMI
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