Saroglitazar Magnesium for Nonalcoholic Fatty Liver Disease with Fibrosis

(NASH Trial)

Recruiting at154 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zydus Therapeutics Inc.

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Research Team

Deven V. Parmar, MD, FCP

Principal Investigator

Zydus Therapeutics Inc.

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have been diagnosed with cirrhosis within the last 24 weeks.

I have been on stable diabetes medication for at least 90 days.

Use of concurrent medications prior to screening including: Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), obeticholic acid and milk thistle in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until time of screening, Antidiabetic mediation which may impact NASH histology including thiazolidinediones (pioglitazone, rosiglitazone) in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until time of screening, Immune modulatory agents including anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab) in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until time of screening, Any treatment or anticipated initiation (intended use for more than 14 consecutive days) of medications known to have an effect on steatosis (e.g. treatment with corticosteroids [topical and inhaled are allowed]), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L-asparaginase, valproate, chloroquine, or antiretroviral drugs in the period from 28 days prior to screening or, if a historical biopsy is used, from 28 days prior to baseline liver biopsy until time of screening, Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion, or naltrexone alone, or in combination or any other medication, that could promote weight loss, in the opinion of the investigator, in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until time of screening, Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening, Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening

Treatment Details

Interventions

• Saroglitazar Magnesium (PPAR Agonist)

Trial Overview 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.

Participant Groups

Group I: Saroglitazar Magnesium 4 mg Experimental Treatment 1 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 mg Experimental Treatment 1 Intervention

Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.

Group III: Placebo Placebo Group 1 Intervention

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.

Saroglitazar Magnesium is already approved in India for the following indications:

Approved in India as Lipaglyn for:

• Type 2 diabetes mellitus
• Dyslipidemia
• Non-alcoholic fatty liver disease (NAFLD)
• Non-alcoholic steatohepatitis (NASH)

Who Is Running the Clinical Trial?

Zydus Therapeutics Inc.

Lead Sponsor

Trials

16

Recruited

1,100+