Saroglitazar for NAFLD in PCOS

No longer recruiting at 34 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of Saroglitazar Magnesium for treating women with PCOS (a hormonal disorder causing enlarged ovaries with small cysts) who also have NAFLD (non-alcoholic fatty liver disease). Participants will receive either the experimental drug or a placebo (a non-active substance) to compare outcomes. Eligible women should have a confirmed diagnosis of PCOS and evidence of NAFLD from the past six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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 there any evidence suggesting that Saroglitazar Magnesium is likely to be safe for humans?

Research has shown that Saroglitazar Magnesium has been tested in people with non-alcoholic fatty liver disease (NAFLD) and diabetes. These studies reported no major adverse side effects, suggesting that the treatment is generally safe and well-tolerated. It also significantly improved liver health and lowered triglycerides, which are fats in the blood. As this trial is in an early stage, researchers continue to closely monitor safety, but current evidence appears promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PCOS?

Researchers are excited about Saroglitazar Magnesium for treating NAFLD in PCOS patients because it offers a unique mechanism of action compared to current options. While most treatments focus on lifestyle changes or medications targeting insulin resistance, Saroglitazar Magnesium acts as a dual PPAR alpha/gamma agonist. This means it simultaneously improves lipid profiles and insulin sensitivity, potentially addressing multiple aspects of the condition. This dual action is particularly promising for those with PCOS and NAFLD, as it could lead to better overall management of these interconnected issues.

What evidence suggests that Saroglitazar Magnesium might be an effective treatment for PCOS?

Research has shown that Saroglitazar Magnesium can help treat nonalcoholic fatty liver disease (NAFLD), particularly in women with polycystic ovary syndrome (PCOS). One study with 91 overweight patients with NAFLD demonstrated that taking Saroglitazar for 3 months improved liver enzyme levels, indicators of liver health. Additionally, Saroglitazar has shown promise in reducing fat build-up in the liver and improving overall liver function. In this trial, participants will receive either Saroglitazar Magnesium or a placebo to evaluate its effectiveness in managing liver issues in women with PCOS. Overall, the treatment has the potential to positively impact liver health in those affected. ^{1 2 5 6 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 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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03617263

Saroglitazar Magnesium 4 mg in the Treatment of NAFLD ... This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium ...

2. trialx.com trialx.com/clinical-trials/listings/253244/saroglitazar-magnesium-4-mg-in-the-treatment-of-nafld-in-women-with-pcos-evidences-vii/

Saroglitazar Magnesium 4 mg in the Treatment of NAFLD ... Overview. This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety ...

3. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=%2Fcentral%2Fdoi%2F10.1002%2Fcentral%2FCN-01969215&doi=10.1002%2Fcentral%2FCN-01969215&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

To study the effect of Saroglitazar 2 mg and 4 ... To study the effect of Saroglitazar 2 mg and 4 mg in the treatment of Women with PCOS ... Saroglitazar vs obeticholic acid in patients of fatty liver. CTRI/2023/ ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12544369/

SAT-668 Saroglitazar Improves Hepatic Steatosis And ... We therefore investigated the efficacy and safety of saroglitazar 4 mg/day in women with PCOS and MASLD. Methods: EVIDENCES VII (NCT03617263) ...

5. withpower.com withpower.com/trial/phase-3-non-alcoholic-fatty-liver-disease-11-2018-b83de

Saroglitazar for NAFLD in PCOS · Info for Participants In a study of 91 overweight patients with nonalcoholic fatty liver disease (NAFLD), saroglitazar treatment for 3 months improved liver enzyme levels ( ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35068786/

Safety and Efficacy of Saroglitazar in Nonalcoholic Fatty ... Saroglitazar was found to show significant improvement in liver parameters in NAFLD patients with a significant reduction in liver fibrosis and triglycerides ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/projects/lipaglyn-saroglitazar-treating-type-ii-diabetes/

Lipaglyn (Saroglitazar) for Treating Hypertriglycerdaemia ... Zydus is currently conducting a Phase II study, EVIDENCES VII, to evaluate saroglitazar Mg's ability to treat NAFLD in women with polycystic ...