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PPAR Agonist

Saroglitazar for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Zydus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.
- historical or current presence of splenomegaly by imaging or physical exam,
Must not have
Subjects having -
Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before dosing on day 1 through day 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug for people with liver problems. It is open to people with different types of liver disease and those with normal liver function.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed here but may include typical drug reactions based on the medication profile such as digestive issues, changes in blood sugar levels, fatigue, allergic reactions, and possibly impacts on cholesterol or triglyceride levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, breastfeeding, and either cannot become pregnant or am using effective birth control.
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My spleen is enlarged, confirmed by tests or a doctor's exam.
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My blood pressure is high or I am on medication for it.
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My HDL cholesterol is low, or I am taking medication for low HDL cholesterol.
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My fasting triglycerides are above 150 mg/dL or I am on medication for high triglycerides.
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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.
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I have been diagnosed with NASH.
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I am in good health with no significant medical issues found during recent check-ups.
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My fasting blood sugar is over 100 mg/dL or I am on medication for high blood sugar.
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I can swallow and keep down pills.
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I am between 18 and 80 years old.
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I have symptoms or treatment for hepatic encephalopathy or ascites.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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This criterion is incomplete.
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I do not have an active infection requiring treatment.
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I have a liver condition not caused by cancer.
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I have a working organ transplant.
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I have had serious liver problems like fluid buildup, confusion, or bleeding veins in my stomach.
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My kidney function is reduced, with an eGFR below 60.
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I have not received any blood products in the last month.
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I have had liver-related health issues like swelling, low platelets, or specific liver tests.
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I haven't had major stomach or intestinal surgery in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before dosing on day 1 through day 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and before dosing on day 1 through day 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC from time zero to infinity (AUC0-∞)
AUC from time zero to the last quantifiable concentration (AUC0-t)
CL/F
+4 more
Secondary study objectives
Incidence of AEs
Unbound Fraction
Unbound concentration
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Group VI: Group 2- mild hepatic impairment with evidence of PHTExperimental Treatment1 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 PHTExperimental Treatment1 Intervention
Subject with mild hepatic impairment without evidence of portal hypertension (PHT) based on Class A CPT score 5-6 points
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saroglitazar Magnesium 2 mg
2020
Completed Phase 1
~100
Saroglitazar Magnesium 4 mg
2020
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
14 Previous Clinical Trials
1,095 Total Patients Enrolled
Deven Parmar, MDStudy DirectorZydus Therapeutics Inc.
2 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

Saroglitazar Magnesium (PPAR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04469920 — Phase 1
Liver disease Research Study Groups: Group 5-cholestatic liver disease, Group 6-Non-cirrhotic Advanced Fibrosis secondary to NASH, Group 7- normal hepatic function, Group 1- mild hepatic impairment without evidence of PHT, Group 2- mild hepatic impairment with evidence of PHT, Group 3-moderate hepatic impairment, Group 4- severe hepatic impairment
Liver disease Clinical Trial 2023: Saroglitazar Magnesium Highlights & Side Effects. Trial Name: NCT04469920 — Phase 1
Saroglitazar Magnesium (PPAR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469920 — Phase 1
~19 spots leftby Nov 2025
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