Saroglitazar Magnesium 2 mg for Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fibrosis+3 More
Saroglitazar Magnesium 2 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, saroglitazar magnesium, to see if it can treat nonalcoholic steatohepatitis (NASH).

Eligible Conditions
  • Fibrosis
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fibrosis

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Week 52 and Week 76/EOT

76 Weeks/EOT
Resolution of steatohepatitis with no worsening of fibrosis
Week 76
Change from baseline in non-invasive markers of fibrosis
Change in body weight (any change from baseline)
Change in glucose homeostasis markers including (HbA1c, FPG)
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
Change in insulin resistance marker, HOMA-IR
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
Change in non-invasive markers of steatosis
Week 76/EOT
2 points improvement in NAS
Decrease in SAF score on liver biopsy
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Fibrosis

Trial Design

3 Treatment Groups

Saroglitazar Magnesium 2 mg
1 of 3
Saroglitazar Magnesium 4 mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

240 Total Participants · 3 Treatment Groups

Primary Treatment: Saroglitazar Magnesium 2 mg · Has Placebo Group · Phase 2

Saroglitazar Magnesium 2 mg
Drug
Experimental Group · 1 Intervention: Saroglitazar Magnesium 2 mg · Intervention Types: Drug
Saroglitazar Magnesium 4 mg
Drug
Experimental Group · 1 Intervention: Saroglitazar Magnesium 4 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52 and week 76/eot

Who is running the clinical trial?

Zydus Therapeutics Inc.Lead Sponsor
13 Previous Clinical Trials
956 Total Patients Enrolled
1 Trials studying Fibrosis
24 Patients Enrolled for Fibrosis
Deven V. Parmar, MD, FCPStudy DirectorZydus Therapeutics Inc.

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
You must provide written informed consent and agree to comply with the trial protocol.
Subjects with type 2 diabetes mellitus must have HbA1c ≤ 9% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.