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PPAR Agonist

Saroglitazar for Non-alcoholic Fatty Liver Disease

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trialwill test a new drug to see if it's safe and effective in people who've had a liver transplant and have NASH (a type of fatty liver disease).

Eligible Conditions
  • Liver Transplant Complications
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events assessed by CTCAE
Secondary outcome measures
Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose)
Apparent clearance [CL/F]
Apparent volume of distribution [Vd/F]
+21 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saroglitazar
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
1,181 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
612 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Deven 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.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD
2019. "Safety, Tolerability and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With NAFLD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03639623.
~3 spots leftby Apr 2025
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