What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD), particularly PPAR agonists like pioglitazone, can lead to side effects such as weight gain, edema, and an increased risk of bone fractures. There is also a potential risk of heart failure in susceptible individuals. Other treatments, such as SGLT2 inhibitors, may cause urinary tract infections and dehydration. These side effects should be carefully considered when choosing a treatment plan for NAFLD.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). However, several drugs are being studied for their potential benefits, including PPAR agonists like Saroglitazar Magnesium. PPAR agonists, such as pioglitazone (a PPARγ agonist), have shown promise in improving insulin sensitivity and lipid parameters, which are crucial in managing NAFLD. Other investigational drugs targeting similar pathways include elafibranor and lanifibranor, which are dual PPARα/δ agonists. These treatments aim to address the metabolic dysfunctions associated with NAFLD.

What other types of research exist?

Promising alternatives to Saroglitazar Magnesium for NAFLD patients include: <ol> <li>SGLT2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin) - These drugs promote urinary excretion of glucose and sodium and are being studied for treating ascites and portal hypertension in cirrhosis.</li> <li></li> </ol> PCSK9 inhibitors (e.g., evolocumab, alirocumab) - These have shown efficacy in lowering LDL cholesterol and may have additional benefits in metabolic liver diseases. 3. GLP-1 receptor agonists (e.g., liraglutide, semaglutide) - These agents improve insulin sensitivity and have shown promise in reducing liver fat content and inflammation.

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PPAR Agonist

Saroglitazar for NAFLD in PCOS

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

Are you a female of the age 18-45 years old?

Have you been diagnosed with Non-Alcoholic Steatohepatitis (NASH) or Fatty Liver Disease?

Must not have

Have you had weight loss surgery (including bypass or sleeve surgery)?

Have you been diagnosed with any of the following medical conditions often associated with a PCOS diagnosis: *large waist size (overweight/obesity) *high cholesterol *high triglycerides *high blood pressure *Type 2 Diabetes/Prediabetes ?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Saroglitazar Magnesium aren't listed here, common ones may include headache, fatigue, nausea, and potential liver-related issues due to its action on liver fat metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 45.

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I have been diagnosed with NASH or Fatty Liver Disease.

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I have been diagnosed with PCOS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hepatic fat content

Secondary study objectives

Accumulation index calculated as a ratio of AUCtau (last dose)/AUCtau (first dose) (For Multiple Dose)

Apparent Clearance [CL/F,ss] (For Multiple Dose)

Apparent Clearance [CL/F] (For Single Dose)

+30 more

Trial Design

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include PPAR agonists like Saroglitazar Magnesium, which improve insulin sensitivity and lipid parameters, thereby reducing liver fat accumulation and inflammation. GLP-1 receptor agonists enhance insulin secretion and promote weight loss, which is beneficial for NAFLD patients. Bile acid derivatives, such as obeticholic acid, improve liver fibrosis by activating farnesoid X receptors. These treatments are essential for NAFLD patients as they target the underlying metabolic dysfunctions, reducing liver damage and improving overall liver health.

The GPR40 Full Agonist SCO-267 Improves Liver Parameters in a Mouse Model of Nonalcoholic Fatty Liver Disease without Affecting Glucose or Body Weight.