What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, statins, and medications like Saroglitazar Magnesium, which is a PPAR alpha/gamma agonist. Saroglitazar and similar PPAR agonists can cause side effects such as weight gain, peripheral edema, and increased concentrations of low-density lipoprotein (LDL) cholesterol. Other treatments like statins may cause muscle pain, liver enzyme abnormalities, and gastrointestinal issues. Lifestyle modifications, while generally safe, can sometimes lead to nutritional deficiencies if not properly managed.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). However, treatments under investigation include PPAR alpha/gamma agonists like Saroglitazar Magnesium. These drugs aim to target metabolic pathways involved in lipid metabolism and inflammation, which are crucial in the management of NAFLD. Other investigational treatments include GLP-1 receptor agonists and various anti-diabetic medications that have shown potential benefits in managing liver fat and improving liver function.

What other types of research exist?

Promising novel alternatives to Saroglitazar Magnesium for NAFLD patients in 2024 include: 1) GLP-1 receptor agonists such as liraglutide and semaglutide, which have shown benefits in reducing liver fat and improving liver histology. 2) SGLT2 inhibitors like empagliflozin and dapagliflozin, which are being studied for their potential benefits in liver health. 3) FXR agonists such as obeticholic acid, which have shown promise in improving liver fibrosis. These alternatives offer different mechanisms of action and have demonstrated efficacy in clinical trials.

← Back to Search

PPAR Agonist

Saroglitazar Magnesium for Non-alcoholic Fatty Liver Disease in HIV (SARONAPLUS Trial)

Phase 2

Waitlist Available

Research Sponsored by Zydus Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (≥18 years of age) with documented HIV

Be older than 18 years old

Must not have

Any of the following laboratory values at screening: ALT or AST >250 U/L, Total bilirubin >1.5 mg/dL and direct bilirubin > 0.5 mg/dL, Platelet count <150,000/mm3, Estimated glomerular filtration rate (e-GFR) <60 mL/min/1.73m2, International normalized ratio (INR) >1.3, Albumin < 3.6 g/dL, History of malignancy in the past 5 years and/or active neoplasm with the exception of superficial, non-melanoma, skin cancer

Unstable cardiovascular disease, including unstable angina, acute myocardial infarction, acute coronary syndrome or coronary artery intervention, heart failure of New York Heart Association (NYHA) class (III-IV) or worsening congestive heart failure, history of or current unstable cardiac dysrhythmias, uncontrolled hypertension, stroke or transient ischemic attack, unstable pulmonary disease, use of drugs that are known CYP2C8 inhibitors/substrates, history of severe illness or any other conditions that require systemic treatment/or hospitalization, use of other PPAR agonists, use of unstable doses of sodium-glucose cotransporter-2 (SGLT2) inhibitors or glucagon-like peptide (GLP)-1 agonists, use of pentoxifylline, ursodeoxycholic acid, antioxidants such as vitamin E, glutathione, orlistat, betaine, incretin mimetics or non-prescribed complementary alternative medications, known allergy, sensitivity or intolerance to the study medication or formulation ingredients, history of any known bleeding disorder or coagulopathy, any condition that in the opinion of the site investigator, would compromise the participant's ability to participate in the study, unstable doses of anti-diabetic agents, unstable doses of lipid-lowering agents, participant with weight change >5%, history of bariatric surgery or currently undergoing evaluation for bariatric surgery, participation in another interventional clinical study and/or receipt of any other investigational medication within 3 months prior to screening or historical liver biopsy, history of COVID-19 infection in the last 30 days prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 28

Summary

This trial is testing Saroglitazar Magnesium, a medication that may help reduce liver fat and inflammation, in people living with HIV who have a liver condition called NASH. Saroglitazar has been recently approved as a therapeutic option for fatty liver disease in India.

Who is the study for?

Adults with HIV and confirmed NASH from a recent liver biopsy can join this trial. They must have controlled HIV for at least 6 months, be on stable antiretroviral therapy, and agree to an end-of-treatment liver biopsy. Excluded are those with severe liver conditions like cirrhosis, uncontrolled diabetes or hypertension, significant alcohol consumption history, certain medication use including PPAR agonists and CYP2C8 inhibitors/substrates, unstable heart disease or other serious health issues.

What is being tested?

The trial is testing Saroglitazar Magnesium (4 mg) against a placebo in people living with HIV who have non-alcoholic steatohepatitis (NASH). Participants will randomly receive either the drug or a placebo to see if it helps improve their liver health.

What are the potential side effects?

While specific side effects of Saroglitazar Magnesium aren't listed here, similar medications often cause digestive issues, potential changes in blood lipid levels, fatigue, allergic reactions and possibly affect blood sugar control.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am an adult with confirmed HIV.

Exclusion Criteria

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

Select...

My diabetes is not under control, with an HbA1c level over 9.5%.

Select...

I have had a liver transplant.

Select...

My tests show signs of cirrhosis or high blood pressure in the liver.

Select...

I have a history of liver disease or hepatitis in the last 3 years.

Select...

I am not pregnant, breastfeeding, and I use effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in hepatic fat content measured by MRI Proton Density Fat fraction (MRI PDFF)

Secondary study objectives

To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on anthropometric measurements.

To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in FibroScan®/VCTE

To evaluate the effect of Saroglitazar Magnesium 4 mg compared with Placebo on changes in FibroScan®/VCTE .

+7 more

Other study objectives

Number of Participants Experiencing Adverse Events After Consuming Saroglitazar Magnesium

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Saroglitazar Magnesium 4 mgExperimental Treatment1 Intervention

Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks)

Group II: Placebo ArmPlacebo Group1 Intervention

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saroglitazar Magnesium 4 mg

2020

Completed Phase 1

~100

0 / 8Eligibility 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

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include PPAR alpha/gamma agonists like Saroglitazar Magnesium, which modulate lipid metabolism and reduce inflammation, addressing key factors in NAFLD progression. Obeticholic acid, another treatment, activates the farnesoid X receptor to improve hepatic fibrosis and regulate bile acid metabolism. These treatments are important for NAFLD patients as they target the underlying metabolic dysfunctions and inflammatory processes, potentially slowing disease progression and improving 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.