Effect of Saroglitazar in Non alcoholic fatty liver disease

Phase 3

• Conditions: Health Condition 1: K77- Liver disorders in diseases classified elsewhere

• Registration Number: CTRI/2024/03/063735
• Lead Sponsor: o sponsor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i) Age -18-60 years

ii) Either of the gender (Male and female)

iii)Evidence of fatty liver on USG

iv) Patient’s willingness to comply with the study protocol and prior written informed consent

Exclusion Criteria

1)Alcoholics for past 6 months

2)Patients with type i or type 2 diabetes mellitus

3) Patients with alternate causes of fatty liver including:

-Patients on TPN and those who underwent surgical procedures within 90 days

from randomization

-presence of other chronic liver disease such as hepatitis B or C, liver

cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver

4) Use of drugs with potential effect on NASH such as: Ursodeoxycholic acid, SAdenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1

5) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism

6) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease

7) Participation in other NAFLD/NASH related study within last 3 months

8) Pregnant or lactating females or couples planning pregnancy within 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in CAP values on FibroscanTimepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in BMI, body weight, Waist-Hip ratioTimepoint: 24 weeks;Mean change from baseline in FBS, HbA1c, HOMA-IRTimepoint: 24 weeks;Mean change from baseline in lipid profileTimepoint: 24 weeks;Mean change from baseline in serum alanine amino transferase valuesTimepoint: 24 weeks;Mean change in FIB-4 scoreTimepoint: 24 weeks;Mean change in Hepatic steatosis indexTimepoint: 24 weeks;Mean change in LSM values from baselineTimepoint: 24 weeks