Saroglitazar for Liver Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zydus Therapeutics Inc.

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function

Eligibility Criteria

Adults aged 18-80 with liver disease such as hepatic impairment, cholestatic liver disease, or NASH with advanced fibrosis can join. They must have certain blood test levels within specific ranges and no severe complications like ascites or hepatic encephalopathy. Good overall health is required, and they should not be on conflicting medications or have had recent major surgery.

Inclusion Criteria

I am not pregnant, breastfeeding, and either cannot become pregnant or am using effective birth control.

My spleen is enlarged, confirmed by tests or a doctor's exam.

My blood pressure is high or I am on medication for it.

My HDL cholesterol is low, or I am taking medication for low HDL cholesterol.

My fasting triglycerides are above 150 mg/dL or I am on medication for high triglycerides.

My liver biopsy 6 months ago showed NASH with stage 3 fibrosis, and I haven't lost more than 10% of my weight since then.

I have been diagnosed with NASH.

I am in good health with no significant medical issues found during recent check-ups.

My fasting blood sugar is over 100 mg/dL or I am on medication for high blood sugar.

I can swallow and keep down pills.

I am between 18 and 80 years old.

I have symptoms or treatment for hepatic encephalopathy or ascites.

Exclusion Criteria

This criterion is incomplete.

I do not have an active infection requiring treatment.

I have a liver condition not caused by cancer.

I have a working organ transplant.

I have had serious liver problems like fluid buildup, confusion, or bleeding veins in my stomach.

My kidney function is reduced, with an eGFR below 60.

I have not received any blood products in the last month.

I have had liver-related health issues like swelling, low platelets, or specific liver tests.

I haven't had major stomach or intestinal surgery in the last 6 months.

Treatment Details

The trial tests Saroglitazar Magnesium at two different doses (2 mg and 4 mg) in patients with varying degrees of liver function including those with normal function for comparison. It's an open-label study where everyone knows what treatment they're getting.

7Treatment groups

Experimental Treatment

Group I: Group 7- normal hepatic functionExperimental Treatment2 Interventions

Subjects with normal hepatic function

Group II: Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASHExperimental Treatment2 Interventions

Subjects with Non-cirrhotic Advanced Fibrosis secondary to NASH

Group III: Group 5-cholestatic liver diseaseExperimental Treatment2 Interventions

Subjects with cholestatic liver disease

Group IV: Group 4- severe hepatic impairmentExperimental Treatment1 Intervention

Subjects with severe hepatic impairment based on Class C CPT score 10-14 points)

Group V: Group 3-moderate hepatic impairmentExperimental Treatment1 Intervention

Subjects with moderate hepatic impairment based on Class B CPT score 7-9 points