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PPAR Agonist
Saroglitazar Magnesium for Nonalcoholic Fatty Liver Disease with Fibrosis (NASH Trial)
Verified Trial
Phase 2
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
Males or females, between 18 and 75 years of age, both inclusive at screening.
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.
Must not have
Consumption of >3 units of alcohol per day (>21 units per week) if male and >2 units of alcohol per day (>14 units per week) if female for at least 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)
Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52/eot
Summary
This trial is testing a new drug, saroglitazar magnesium, to see if it can treat nonalcoholic steatohepatitis (NASH).
Who is the study for?
Adults aged 18-75 with a BMI ≤45 kg/m² and moderate type 2 diabetes (if applicable) can join this trial. They must have nonalcoholic steatohepatitis (NASH) with fibrosis confirmed by biopsy, not be significantly overweight or underweight, and agree to follow the study rules. People with unstable heart conditions, recent strokes, certain muscle diseases, severe liver issues like cirrhosis or cancer within the last five years cannot participate.
What is being tested?
The trial is testing Saroglitazar Magnesium at two different doses (4 mg and 2 mg) against a placebo to treat NASH with fibrosis. Participants will randomly receive one of these treatments to see how effective they are in improving their liver health compared to no active treatment.
What are the potential side effects?
Saroglitazar Magnesium may cause side effects such as fatigue, headache, muscle pain or weakness, nausea, and potential changes in blood lipid levels. The exact side effects for this medication in treating NASH are being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My liver biopsy confirms NASH with significant fibrosis and meets specific scoring criteria.
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My liver fibrosis is at stage 2 or 3.
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I am between 18 and 75 years old.
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My weight has been stable, not changing more than 5% since my biopsy.
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My liver fibrosis is at stage 2 or 3.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not consumed more than the specified alcohol limit in the past 5 years.
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I show signs of high blood pressure in the liver.
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I have been on stable diabetes medication for at least 90 days.
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I have had a liver transplant.
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I have type 1 diabetes.
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I do not have recent serious heart problems or uncontrolled high blood pressure.
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I have a history of muscle diseases or my current muscle enzyme levels are very high.
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I have not been in another treatment study in the last 90 days.
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I have had bladder tumors or blood in my urine not caused by an infection.
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I have chronic pancreatitis or my pancreas does not work properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52/eot
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52/eot
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resolution of steatohepatitis with no worsening of fibrosis
Secondary study objectives
2 points improvement in NAS
Change in body weight (any change from baseline)
Change in glucose homeostasis markers including (HbA1c, FPG)
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Group II: Saroglitazar Magnesium 2 mgExperimental Treatment1 Intervention
Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Group III: PlaceboPlacebo Group1 Intervention
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saroglitazar Magnesium 2 mg
2020
Completed Phase 1
~100
Saroglitazar Magnesium 4 mg
2020
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Zydus Therapeutics Inc.Lead Sponsor
14 Previous Clinical Trials
953 Total Patients Enrolled
1 Trials studying Fibrosis
24 Patients Enrolled for Fibrosis
Deven V. Parmar, MD, FCPStudy DirectorZydus Therapeutics Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Saroglitazar Magnesium 2 mg
- Group 2: Placebo
- Group 3: Saroglitazar Magnesium 4 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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