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)

Zydus Lifesciences Limited19 sites in 1 country1,500 target enrollmentJuly 20, 2023

ConditionsNAFLD Obesity Type 2 Diabetes Dyslipidemias Metabolic Syndrome

InterventionsSaroglitazar

DrugsSaroglitazar

Overview

Phase: Phase 4
Intervention: Saroglitazar
Conditions: NAFLD
Sponsor: Zydus Lifesciences Limited
Enrollment: 1500
Locations: 19
Primary Endpoint: Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 20, 2023

End Date

June 10, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zydus Lifesciences Limited

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Saroglitazar 4 mg tablets

Oral (once daily ) during 364 days/52 weeks of treatment period.

Intervention: Saroglitazar

Outcomes

Primary Outcomes

Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

Time Frame: Baseline to Week 52

Change in liver stiffness

Time Frame: Baseline to Week 52

liver stiffness measurement performed by transient elastography

Secondary Outcomes

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)