Saroglitazar for Liver Disease

Recruiting in Palo Alto (17 mi)

+1 other location

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.

I have a history of specific liver diseases or certain abnormal liver test results.

Exclusion Criteria

Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.

Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.

I have not donated blood or blood products in the last 3 months.

Treatment Details

Interventions

• Saroglitazar Magnesium (PPAR Agonist)

Trial Overview 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.

Participant Groups

Group I: Group 7- normal hepatic function Experimental Treatment 2 Interventions

Subjects with normal hepatic function

Group II: Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH Experimental Treatment 2 Interventions

Subjects with Non-cirrhotic Advanced Fibrosis secondary to NASH

Group III: Group 5-cholestatic liver disease Experimental Treatment 2 Interventions

Subjects with cholestatic liver disease

Group IV: Group 4- severe hepatic impairment Experimental Treatment 1 Intervention

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

Group V: Group 3-moderate hepatic impairment Experimental Treatment 1 Intervention

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

Group VI: Group 2- mild hepatic impairment with evidence of PHT Experimental Treatment 1 Intervention

Subjects with mild hepatic impairment with evidence of portal hypertension based on Class A CPT score 5-6 points

Group VII: Group 1- mild hepatic impairment without evidence of PHT Experimental Treatment 1 Intervention

Subject with mild hepatic impairment without evidence of portal hypertension (PHT) based on Class A CPT score 5-6 points

Saroglitazar Magnesium is already approved in India for the following indications:

🇮🇳 Approved in India as Lipaglyn for:

• Type 2 diabetes mellitus
• Dyslipidemia
• Non-alcoholic fatty liver disease (NAFLD)
• Non-alcoholic steatohepatitis (NASH)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Indiana University School of Medicine Indianapolis, IN

American Research Corporation at Texas Liver Institute San Antonio, TX

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc. Lead Sponsor

References