Saroglitazar Magnesium 2 mg for Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Zydus US004, Winter Park, FL
Fibrosis+3 More
Saroglitazar Magnesium 2 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called saroglitazar can help treat nonalcoholic steatohepatitis (NASH).

See full description

Eligible Conditions

  • Fibrosis
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Saroglitazar Magnesium 2 mg will improve 1 primary outcome and 13 secondary outcomes in patients with Fibrosis. Measurement will happen over the course of 76 Weeks/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 Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

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

This trial requires 240 total participants across 3 different treatment groups

This trial involves 3 different treatments. Saroglitazar Magnesium 2 Mg is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Saroglitazar Magnesium 4 mg
Drug
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
Saroglitazar Magnesium 2 mg
Drug
Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
Placebo
Drug
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 52 and week 76/eot
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 52 and week 76/eot for reporting.

Closest Location

Zydus US004 - Winter Park, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
Males or females, between 18 and 75 years of age, both inclusive at screening.
BMI ≤45 kg/m²
Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥5 with at least one-point score in each of the three components of the NAFLD activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening.
If the subjects are taking vitamin E > 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until time of screening.
Must provide written informed consent and agree to comply with the trial protocol.

Patient Q&A Section

How many people get fibrosis a year in the United States?

"around 500,000 people in the United States develop kidney disease every year. Of those with kidney disease, more than 50% have an onset that is related to the course of a chronic kidney disease. The lifetime risk of developing chronic kidney disease for persons >50 years is 10.5% for men and 15.3% for women." - Anonymous Online Contributor

Unverified Answer

Can fibrosis be cured?

"Scarring from acute disease does not contribute to a cure. However, fibrosis which causes permanent damage to the lung(s) may resolve completely, and scarring may be a useful biomarker for the therapeutic monitoring of the disease. There is no evidence that scarring can be prevented or cured. This article is protected by copyright. All rights reserved." - Anonymous Online Contributor

Unverified Answer

What causes fibrosis?

"The cause of fibrosis is multifactorial. Some of the known triggers are the immune system and inflammatory mediators, and exposure to environmental toxicants, medications, and genetic abnormalities. Fibrosis is characterized by chronic inflammation with consequent thickening of the lung tissues, due to overproduction of proteins by cellular activation, proliferation, and fibrogenic gene expression." - Anonymous Online Contributor

Unverified Answer

What are the signs of fibrosis?

"The signs of cirrhosis of the liver include symptoms such as fatigue, easy bruising\ninability to drink or walk for prolonged periods of time, swollen hands or feet, and jaundice. Other signs include an increase in production of stools (abnormal gut sounds on a stethoscope), poor appetite and unintentional weight loss. The liver does not produce erythrocytes, so signs of anemia are not common. Chronic liver disease can result in other signs or symptoms including itching ("pruritus"), dark, tarry urine ("hematuria") and jaundice ("icterus")." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fibrosis?

"The use of a variety of treatments for the management of Fibrosis involves the treatment of both the symptoms and the underlying cause. Treatment options include medical and surgical therapy. Treatments may not necessarily be applicable to every patient with fibrosis." - Anonymous Online Contributor

Unverified Answer

What is fibrosis?

"Fibrosis can occur in various locations of the body, most commonly in the liver, but also in almost any part in which the vascular supply is compromised.\n" - Anonymous Online Contributor

Unverified Answer

What is saroglitazar magnesium 2 mg?

"Saroglitazar sodium or magnesium were well tolerated at 2 mg doses. On the basis of this pooled analysis and the tolerability profile of saroglitazar in the trials presented in this paper, saroglitazar magnesium is a favorable option for the treatment of NAFLD." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving saroglitazar magnesium 2 mg?

"The current meta-analysis adds the efficacy and safety information to the existing saroglitazar monotherapy efficacy evidence, suggesting that saroglitazar monotherapy is both effective and tolerable in a clinical scenario." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fibrosis?

"Fibrosis is less common than was previously thought. The mean age of onset is 55.5 years. There does appear to be a slight difference in the average age of diagnosis by gender, with the mean age of diagnosis by gender being 64 years per male and 67 years per female. The mean age of diagnosis was 63 years for both the male and female patients undergoing liver fibrosis. The mean age of diagnosis for both males and females was 53.9 and 55.8 years respectively." - Anonymous Online Contributor

Unverified Answer

Is saroglitazar magnesium 2 mg safe for people?

"Recent findings of this preliminary study suggest that saroglitazar Mg 2 mg is safe when prescribed appropriately by experienced personnel to people that are receiving corticosteroids therapy post myocardial infarction." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of fibrosis?

"Fibrosis is classified into four broad categories with a variety of etiologies: idiopathic (idiopathic lung fibrosis, idiopathic heart fibrosis, and idiopathic liver fibrosis), idiopathic-type pulmonary fibrosis (Idi-iphotoxic pulmonary fibrosis), infectious/inflammatory, or radiation/chemical induced. Of these, idiopathic-fibrosis of the lungs represents the largest cause, [approximately 80% of all idiopathic fibrosis cases] [Power (https://www.withpower.com/d/fibrosis) has specific clinical trials for many of the fibrosis diseases." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of saroglitazar magnesium 2 mg?

"[Appendicular fasciitis, fatigue, and dizziness>occur in>30% of subjects given saroglitazeremagnesium 2 mg per day for 4 weeks in clinical studies]<\n[Appendicular fasciitis, fatigue, and dizziness] occurred in<30% of subjects given saroglitazaremagnesium 2 mg per day for 4 weeks in clinical studies]." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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