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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
4 Mg Oral Tablet
Gastroplus Digestive Disease Centre
Ahmedabad, India
RECRUITINGMission GastroHospital
Ahmedabad, India
RECRUITINGArtemis Hospital
Gūrgaon, India
RECRUITINGMedanta- TheMedicity
Gūrgaon, India
RECRUITINGMalla ReddyNarayanaMultispecialtyHospital
Hyderabad, India
RECRUITINGOsmania GeneralHospital
Hyderabad, India
RECRUITINGYashoda Hospitals
Hyderabad, India
RECRUITINGCARE CHL -Hospitals (Unit ofConvenient HospitalLtd.
Indore, India
RECRUITINGS R Kalla MemorialGastro and GenralHospital
Jaipur, India
RECRUITINGAIIMS
Khorda, India
RECRUITING...and 9 more locations
Change in liver stiffness
liver stiffness measurement performed by transient elastography
Time frame: Baseline to Week 52
Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: Baseline to Week 52
Change in TG, HDL-C, LDL-C and non HDL-C levels
Time frame: Baseline to Week 24 and Week 52
Change in serum ALT value
Time frame: Baseline to Week 24 and Week 52
Change in serum AST value
Time frame: Baseline to Week 24 and Week 52
Change in serum ALP value
Time frame: Baseline to Week 24 and Week 52
Change in body weight
Time frame: Baseline to Week 24 and Week 52
Change in BMI
Time frame: Baseline to Week 24 and Week 52
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