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PPAR Agonist

Saroglitazar for Liver Cirrhosis

Phase 1

Recruiting

Research Sponsored by Zydus Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to swallow and retain oral medication

Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study

Must not have

Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 by modification of diet in renal disease (MDRD) formula at screening

Current functioning organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trough plasma sample will be collected at pre-dose on visit 3 (on day 8), visit-4 (on day 15) and at visit 5 (on day 22). additional pk sample will be collected at 168.0 hours post dose of day 28 (i.e. on day 35 ±3d)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of an experimental drug in people with cholestatic liver disease and cirrhosis.

Who is the study for?

Adults aged 18-80 with cirrhosis due to cholestatic liver disease can join this trial. They must understand and sign consent, have a BMI of 18-48 kg/m2, and not be pregnant or breastfeeding. Participants need stable health, acceptable blood tests results (specific limits for liver enzymes, blood cells count), agree to use contraception, and cannot have other significant medical conditions or recent surgeries that could affect the study.

What is being tested?

The trial is testing two doses of Saroglitazar Magnesium (1 mg and 2 mg) in people with hepatic impairment caused by cholestatic liver diseases. It's an open-label extension study where everyone knows which treatment they're getting.

What are the potential side effects?

While specific side effects are not listed here, common ones may include digestive issues, potential changes in liver function tests, fatigue, allergic reactions or skin rashes. The exact side effects will depend on how the drug interacts with the impaired liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow and keep down pills.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a working organ transplant.

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I am not currently on antibiotics, antifungals, or antivirals for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trough plasma sample will be collected at pre-dose on visit 3 (on day 8), visit-4 (on day 15) and at visit 5 (on day 22). additional pk sample will be collected at 168.0 hours post dose of day 28 (i.e. on day 35 ±3d)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trough plasma sample will be collected at pre-dose on visit 3 (on day 8), visit-4 (on day 15) and at visit 5 (on day 22). additional pk sample will be collected at 168.0 hours post dose of day 28 (i.e. on day 35 ±3d)

This trial's timeline: 3 weeks for screening, Varies for treatment, and trough plasma sample will be collected at pre-dose on visit 3 (on day 8), visit-4 (on day 15) and at visit 5 (on day 22). additional pk sample will be collected at 168.0 hours post dose of day 28 (i.e. on day 35 ±3d) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the safety and tolerability of Saroglitazar

To determine the plasma PK of Saroglitazar (parent compound)

To determine the plasma PK of Saroglitazar metabolite (Saroglitazar sulfoxide)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Saroglitazar Magnesium 2 mgExperimental Treatment1 Intervention

The study drug will be administered from Day 1 to Day 28 once daily in the morning before breakfast without food. Study drug -Saroglitazar Magnesium tablets: Dosage form- Tablets (immediate release); Dose- 2 mg/day; Frequency- One tablet per day (in the morning before breakfast without food); Duration- 28 consecutive days

Group II: Saroglitazar Magnesium 1 mgExperimental Treatment1 Intervention

The study drug will be administered from Day 1 to Day 28 once daily in the morning before breakfast without food. Study drug -Saroglitazar Magnesium tablets; Dosage form- Tablets (immediate release); Dose- 1 mg/day; Frequency- One tablet per day (in the morning before breakfast without food); Duration of treatment- 28 consecutive days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saroglitazar Magnesium 2 mg

2020

Completed Phase 1

~100

0 / 5Eligibility criteria met