Your session is about to expire
← Back to Search
Saroglitazar Magnesium for Nonalcoholic Fatty Liver Disease with Fibrosis (NASH Trial)
NASH Trial Summary
This trial is testing a new drug, saroglitazar magnesium, to see if it can treat nonalcoholic steatohepatitis (NASH).
NASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNASH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NASH Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- Your weight should not have changed more than 5% between the time of your biopsy and when you start the study.My liver biopsy confirms NASH with significant fibrosis and a NAS score of 5 or more.I have been taking the same dose of vitamin E (>400 IU/day) for at least 24 weeks.I have been diagnosed with cirrhosis within the last 24 weeks.I have been on stable diabetes medication for at least 90 days.I haven't had stomach or intestinal surgery in the last 6 months.I do not have recent serious heart problems or uncontrolled high blood pressure.I have a history of muscle diseases or my current muscle enzyme levels are very high.I have not been in another treatment study in the last 90 days.I have had bladder tumors or blood in my urine not caused by an infection.My weight has been stable, not changing more than 5% since my biopsy.I have had cancer in the last 5 years, except for non-dangerous skin cancer which is cured.You have to read and sign a document to confirm you understand the trial and agree to follow the rules.You are allergic or intolerant to the study drug or its ingredients.My liver fibrosis is at stage 2 or 3.I am between 18 and 75 years old.I show signs of high blood pressure in the liver.I haven't had weight loss surgery in the last 2 years and don't plan to during the study.I am not pregnant or breastfeeding, and if I can have children, I am using effective birth control.My type 2 diabetes is under control with an HbA1c ≤ 9% and stable medication for 90 days.I do not have ongoing liver diseases like hepatitis, PBC, PSC, autoimmune liver disease, alcoholic liver disease, hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency.I have had a liver transplant.I have type 1 diabetes.You have a body mass index (BMI) of 45 or less.I am between 18 and 75 years old.My liver fibrosis is at stage 2 or 3.My type 2 diabetes is under control with an HbA1c ≤ 9% and I've been on stable diabetes medication for at least 90 days.I have been taking the same dose of vitamin E (over 400 IU/day) for at least 24 weeks.I have chronic pancreatitis or my pancreas does not work properly.My liver biopsy confirms NASH with significant fibrosis and meets specific scoring criteria.I have not consumed more than the specified alcohol limit in the past 5 years.You are currently receiving liquid nutrition through an IV or feeding tube.
- Group 1: Saroglitazar Magnesium 2 mg
- Group 2: Placebo
- Group 3: Saroglitazar Magnesium 4 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people fit the requirements to participate in this clinical trial?
"To meet the quota of 240 patients, this study is recruiting participants from multiple states including California and Tennessee. The inclusion criteria must be met in order to qualify for the trial."
Does the age limit for this research project stop at 80 years old?
"The age range for patients that are being recruited for this clinical trial is 18-75 years old."
Are there any unfilled positions in this medical research project?
"The information available on clinicaltrials.gov suggests that this trial is open and actively recruiting patients. The posting date was August 18th, 2021 with the most recent update occurring on August 31st, 2022. They are looking for a total of 240 individuals who will be split between 5 different locations."
At how many hospitals is this experiment being conducted?
"5 centres are currently running this clinical trial; Zydus US012 in Panorama City, Zydus US003 in Lakeland, and Zydus US014 in Los Angeles to name a few."
What was the outcome of the FDA's review of Saroglitazar Magnesium 2 mg?
"While there is some evidence that Saroglitazar Magnesium 2 mg is safe, as this drug is still in Phase 2 of clinical trials, there is no data yet supporting its efficacy."
For which types of patients is this trial designed?
"This study is recruiting 240 participants with fibrosis aged 18 and 75. Most importantly, candidates are required to meet the following criteria: 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]"
Who else is applying?
What portion of applicants met pre-screening criteria?
Share this study with friends
Copy Link
Messenger