Saroglitazar for NAFLD in PCOS

Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Verified Trial

Waitlist Available

Sponsor: Zydus Therapeutics Inc.

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called Saroglitazar Magnesium to see if it can help women with PCOS by reducing liver fat. The study will last several months and will measure changes in liver fat using MRI scans.

Eligibility Criteria

This trial is for women aged 18-45 with PCOS and Non-Alcoholic Fatty Liver Disease or NASH. Participants should not be pregnant, nursing, or have had weight loss surgery. They also shouldn't have related conditions like obesity, high cholesterol, triglycerides, blood pressure, or Type 2 Diabetes.

Inclusion Criteria

I am a woman aged between 18 and 45.

I have been diagnosed with NASH or Fatty Liver Disease.

I have been diagnosed with PCOS.

Exclusion Criteria

I have had weight loss surgery.

I have been diagnosed with conditions related to PCOS, such as obesity or high blood pressure.

Are you currently pregnant or nursing?

Treatment Details

The study tests Saroglitazar Magnesium's effectiveness and safety in treating NAFLD in women with PCOS compared to a placebo. It's a phase 2A trial where participants are randomly assigned to either the drug or placebo without knowing which one they receive.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention

Saroglitazar Magnesium once daily in the morning before breakfast

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablet once daily in the morning before breakfast

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

🇮🇳 Approved in India as Lipaglyn for: