A study to evaluate the safety and effectiveness of Saroglitazar 4 mg in patients with NAFLD with comorbidities

Phase 4

Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Registration Number: CTRI/2023/05/053326

Lead Sponsor: Zydus Lifesciences Limited (formerly Cadila Healthcare Limited)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female patients aged =18 years

2.Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)

3.Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol

4.Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria (Refer Appendix III for diagnostic 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:

a.Liver stiffness through transient elastography, an LSM =8 kPa

b.Serum ALT =45 U/

Exclusion Criteria

1.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.

2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.

3.Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.

4.Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.

5.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.

6.Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.

7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.

8. Pregnant or breast feeding females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in liver stiffness measurement performed by transient elastography and Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)Timepoint: Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change in body weight and BMITimepoint: Baseline to Week 24 and Week 52;Change in serum ALP valueTimepoint: Baseline to Week 24 and Week 52;Change in serum ALT valueTimepoint: Baseline to Week 24 and Week 52;Change in serum ASTTimepoint: Baseline to Week 24 and Week 52;Change in TG, HDL-C, LDL-C and non HDL-C levelsTimepoint: Baseline to Week 24 and Week 52;To evaluate the safety of Saroglitazar 4 mg once daily in the study populationTimepoint: Baseline to Week 52