Saroglitazar for NAFLD in PCOS

Recruiting at 33 trial locations

Overseen By Deven Parmar, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Zydus Therapeutics Inc.

Must not be taking: Antidiabetics, Lipid lowering, Vitamin E, others

Disqualifiers: Chronic liver diseases, Alcohol use, Cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you have used certain medications affecting liver fat or NAFLD in the past 3 months, or if your antidiabetic and lipid-lowering medication doses have not been stable for at least 3 months before screening.

Is saroglitazar safe for humans?

Saroglitazar has been studied in patients with non-alcoholic fatty liver disease (NAFLD) and diabetes, and no major adverse events were reported in these studies, suggesting it is generally safe for human use. ^{1 2 3 4 5}

What makes the drug Saroglitazar unique for treating NAFLD in PCOS?

Saroglitazar is unique because it is a dual PPAR α/γ agonist, which means it targets two specific receptors to improve insulin sensitivity and manage lipid and glucose metabolism, making it potentially effective for NAFLD in patients with PCOS. ^{1 2 3 6 7}

What data supports the effectiveness of the drug Saroglitazar for treating NAFLD in PCOS?

Research shows that Saroglitazar, a drug that helps improve insulin sensitivity and manage lipid levels, is effective in treating non-alcoholic fatty liver disease (NAFLD) in patients, including those with diabetes. It has been shown to improve liver health and metabolic parameters in various studies. ^{1 2 3 4 7}

Who Is on the Research Team?

Deven Parmar, MD

Principal Investigator

Zydus Therapeutics Inc.

Are You a Good Fit for This Trial?

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 have been diagnosed with NASH or Fatty Liver Disease.

I have been diagnosed with PCOS.

I am a woman aged between 18 and 45.

Exclusion Criteria

Are you currently pregnant or nursing?

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

I have had weight loss surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Participants receive Saroglitazar Magnesium or placebo once daily for 24 weeks

24 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Saroglitazar Magnesium

Trial Overview 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.

How Is the Trial Designed?

Group I: Saroglitazar Magnesium 4 mg Experimental Treatment 1 Intervention

Saroglitazar Magnesium once daily in the morning before breakfast

Group II: Placebo Placebo Group 1 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:

• 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+

Published Research Related to This Trial

In a study of 91 overweight patients with nonalcoholic fatty liver disease (NAFLD), saroglitazar treatment for 3 months improved liver enzyme levels (transaminases) in all patients, indicating its efficacy in managing liver health.

However, significant improvements in liver stiffness and controlled attenuation parameter values were only observed in patients who achieved a weight reduction of at least 5%, highlighting the importance of weight loss in conjunction with saroglitazar therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saroglitazar for Nonalcoholic Fatty Liver Disease: A Single Centre Experience in 91 Patients. Padole, P., Arora, A., Sharma, P., et al.[2023]

In a systematic review of 10 studies involving patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), treatment with 4 mg saroglitazar significantly reduced liver enzymes, including alanine transaminase (ALT) and aspartate transaminase (AST), indicating improved liver function.

Saroglitazar also led to significant improvements in liver stiffness and metabolic parameters such as glycated hemoglobin, total cholesterol, and triglycerides, suggesting it is an effective and safe treatment option for managing NAFLD and NASH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. Bandyopadhyay, S., Samajdar, SS., Das, S.[2023]

In a study involving C57BL/6 mice, saroglitazar treatment significantly reduced liver injury markers and reversed liver fat accumulation, indicating its efficacy in addressing liver damage associated with NASH.

Importantly, saroglitazar completely prevented the development of liver tumors in treated mice, suggesting its potential as a chemopreventive agent against hepatocellular carcinoma in patients with fatty liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saroglitazar suppresses the hepatocellular carcinoma induced by intraperitoneal injection of diethylnitrosamine in C57BL/6 mice fed on choline deficient, l-amino acid- defined, high-fat diet. Giri, SR., Bhoi, B., Trivedi, C., et al.[2023]

In a study of 112 NAFLD patients treated with saroglitazar for 52 weeks, significant improvements were observed in liver stiffness measurements (LSM) and controlled attenuation parameter (CAP) values, indicating enhanced liver health.

Saroglitazar also led to reductions in key biochemical markers such as ALT, AST, HbA1c, LDL, total cholesterol, and triglycerides, demonstrating its efficacy in managing NAFLD and diabetic dyslipidemia, with only mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of saroglitazar in real-world patients of non-alcoholic fatty liver disease with or without diabetes including compensated cirrhosis: A tertiary care center experience. Chaudhuri, S., Dutta, A., Chakraborty, SBD.[2023]

In a phase 2A study involving liver transplant recipients with non-alcoholic fatty liver disease (NAFLD), saroglitazar treatment resulted in a significant reduction in liver fat, as measured by MRI, with 47% of patients showing a 30% reduction in fat content after 24 weeks.

Saroglitazar was well tolerated, showing no significant adverse effects on muscle mass or weight, although it did lead to a mild increase in visceral and subcutaneous fat, indicating a need for further research to fully understand its metabolic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients. Siddiqui, MS., Parmar, D., Shaikh, F., et al.[2023]

Citations

1. India pubmed.ncbi.nlm.nih.gov

Saroglitazar for Nonalcoholic Fatty Liver Disease: A Single Centre Experience in 91 Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Saroglitazar, a PPAR-α/γ Agonist, for Treatment of NAFLD: A Randomized Controlled Double-Blind Phase 2 Trial. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Saroglitazar suppresses the hepatocellular carcinoma induced by intraperitoneal injection of diethylnitrosamine in C57BL/6 mice fed on choline deficient, l-amino acid- defined, high-fat diet. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of saroglitazar in real-world patients of non-alcoholic fatty liver disease with or without diabetes including compensated cirrhosis: A tertiary care center experience. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An Observational Study of Reduction in Glycemic Parameters and Liver Stiffness by Saroglitazar 4 mg in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients. [2023]