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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
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

Study 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.Check my eligibility
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.See study design
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.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
1,177 Total Patients Enrolled
Deven V Parmar, MD, FCPStudy DirectorZydus Therapeutics Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are receiving treatment through this research?

"Yes, according to clinicaltrials.gov the trial posted on October 21st 2021 is still actively seeking participants. The recruitment goal for this single-site study is 24 individuals."

Answered by AI

Does this clinical research accept participants aged 18 and older?

"According to the qualifications for this medical trial, eligible participants must be at least 18 years old and no older than 80."

Answered by AI

Are there still available positions for volunteers in this clinical investigation?

"As per the information hosted on clinicaltrials.gov, enrollment is still open for this trial which was unveiled on October 21st 2021 and revised as recently as April 23rd 2022."

Answered by AI

Who meets the criteria for participation in this research endeavor?

"This clinical trial is seeking 24 people aged 18-80 who suffer from cholestatic liver disease. To be considered, patients must have a healthy BMI between 18 and 48 kg/m2 at screening, cannot be pregnant or lactating females of childbearing potential (unless using highly efficient contraception), demonstrate the ability to swallow and retain oral medication, display evidence of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 based on CPT score (investigators may choose to alter this classification if it changes before Day -1)."

Answered by AI

Has Saroglitazar Magnesium 2 mg been given the go-ahead by the FDA?

"Considering the limited clinical evidence for both safety and efficacy, our team at Power assigned Saroglitazar Magnesium 2 mg a score of 1."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
2021. "Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045482.
All > Liver Disease > Cirrhosis
~7 spots leftby Apr 2025
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