A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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NAFLD, Obesity, Type 2 Diabetes, Dyslipidemias, Metabolic Syndrome

Intervention / Treatment
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* Drug: Saroglitazar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged ≥18 years Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time) Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol . Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening: Liver stiffness through transient elastography, an LSM ≥8 kPa OR Serum ALT ≥45 U/L Exclusion Criteria: Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar. History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study. Pregnant or breast feeding females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saroglitazar 4 mg tablets<br>Oral (once daily ) during 364 days/52 weeks of treatment period. | Drug: Saroglitazar<br>* 4 Mg Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver stiffness | liver stiffness measurement performed by transient elastography | Baseline to Week 52 | 
| Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) |  | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TG, HDL-C, LDL-C and non HDL-C levels |  | Baseline to Week 24 and Week 52 | 
| Change in serum ALT value |  | Baseline to Week 24 and Week 52 | 
| Change in serum AST value |  | Baseline to Week 24 and Week 52 | 
| Change in serum ALP value |  | Baseline to Week 24 and Week 52 | 
| Change in body weight |  | Baseline to Week 24 and Week 52 | 
| Change in BMI |  | Baseline to Week 24 and Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real World Evidence Study