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

Launched by ZYDUS LIFESCIENCES LIMITED · May 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Saroglitazar, specifically in patients who have non-alcoholic fatty liver disease (NAFLD) along with other health issues like obesity, type 2 diabetes, or high cholesterol. The goal is to see how well Saroglitazar works in helping these patients manage their condition. This is a Phase 4 study, which means it is being conducted after the medication has already been approved for use, to gather more information about its effects in a real-world setting.

To participate in the trial, you must be at least 18 years old and have a confirmed diagnosis of NAFLD. This diagnosis can be based on previous medical tests that show you have fat in your liver without drinking alcohol excessively. You also need to be willing to provide written consent to join the study. Throughout the trial, participants will take Saroglitazar and will be monitored for its effects and safety. Importantly, this study excludes individuals with certain liver diseases, severe health issues, or those who consume alcohol regularly. If you meet the criteria and are interested, this trial could offer an opportunity to contribute to important research while receiving the medication under careful observation.

Gender

ALL

Eligibility criteria

• 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. 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:
• • 1. Liver stiffness through transient elastography, an LSM ≥8 kPa OR
• • 2. Serum ALT ≥45 U/L
• 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. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
• • 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