What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) with antifibrotic activity include medications like statins, pioglitazone, and vitamin E. Statins are generally well-tolerated but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Pioglitazone may lead to weight gain, edema, and an increased risk of heart failure. Vitamin E is usually safe but can increase the risk of hemorrhagic stroke and prostate cancer in high doses. Newer antifibrotic agents like Rencofilstat are being studied for their efficacy and safety, with potential side effects yet to be fully characterized.

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) or Non-alcoholic Steatohepatitis (NASH) with a primary focus on antifibrotic activity. Current treatments for NAFLD/NASH primarily involve lifestyle modifications, such as diet and exercise, and managing associated conditions like diabetes and hyperlipidemia. Some drugs, like pioglitazone and vitamin E, have been used off-label to treat NASH, but they do not specifically target fibrosis. The trial of Rencofilstat is significant as it aims to evaluate the efficacy and safety of an antifibrotic agent in NASH patients with advanced liver fibrosis, a therapeutic area with high unmet need.

What other types of research exist?

Promising novel alternatives to Rencofilstat for NAFLD patients include n-3 fish oil, which has shown efficacy in reducing liver fat content. However, it did not significantly improve fibrosis. Other antifibrotic agents or treatments specifically for NAFLD were not detailed in the provided context, so further consultation with a healthcare provider for the latest clinical trial results and treatment options is recommended.

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Antifibrotic Agent

Rencofilstat for NASH with Advanced Liver Fibrosis (ASCEND Trial)

Phase 2

Recruiting

Led By Stephen Harrison, MD

Research Sponsored by Hepion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female between 18 and 75 years of age (inclusive)

Histologic evidence of NASH based on central readings of the screening biopsy obtained no more than 6 months before Screening defined by presence of all 3 key histological features, Nonalcoholic Fatty Liver Disease Activity Score (NAS) ≥ 4 with at least 1 point each in lobular inflammation and hepatocyte ballooning

Must not have

Subjects with suspected and symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection identified prior to first dose

Subjects with a history of clinically significant acute cardiac events within 30 days prior to Screening such as stroke, transient ischemic attack, or coronary heart disease (angina pectoris requiring therapy, myocardial infarction, revascularization procedures with left ventricular ejection fraction [LVEF] <50% as determined by previous echocardiography or multiple gated acquisition [MUGA] scan)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dosing period of 1 year with 1 month observation and follow up period

Summary

This trial tests Rencofilstat, a medication that may improve liver damage, in adults with NASH and significant liver fibrosis. The drug works by reducing liver scarring and damage.

Who is the study for?

Adults aged 18-75 with NASH and stage 2 or 3 liver fibrosis, who have a biopsy confirming the condition within the last 6 months. Participants should not have severe heart issues, decompensated cirrhosis, recent drug trials participation, uncontrolled diabetes (HbA1c >9.5%), or infections like hepatitis B/C or HIV.

What is being tested?

The trial is testing Rencofilstat against a placebo to see if it can improve liver fibrosis in NASH patients. It's randomized and double-blind, meaning neither doctors nor participants know who gets the real medicine versus placebo.

What are the potential side effects?

While specific side effects of Rencofilstat are not listed here, similar medications may cause digestive issues, fatigue, allergic reactions, and changes in blood tests that monitor liver function.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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My liver biopsy shows I have NASH with specific inflammation and cell damage.

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My liver has moderate to severe scarring according to a specific biopsy test.

Exclusion Criteria

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

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I suspect I have or am showing symptoms of a severe COVID-19 infection.

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I haven't had a major heart event or stroke in the last 30 days.

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I do not have serious heart rhythm problems.

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My blood clotting time is longer than normal without taking blood thinners.

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I have never had severe liver problems like fluid buildup, confusion, or bleeding veins in my stomach.

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I have a diagnosed liver condition not caused by the trial's focus.

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I haven't taken any experimental liver treatments in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dosing period of 1 year with 1 month observation and follow up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dosing period of 1 year with 1 month observation and follow up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and dosing period of 1 year with 1 month observation and follow up period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.

Secondary study objectives

Change from baseline in ALT.

Change from baseline in AST.

Change from baseline in Pro-C3, type III collagen neo-epitopes.

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort C: Rencofilstat 225 mgExperimental Treatment1 Intervention

Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.

Group II: Cohort B: Rencofilstat 150 mgExperimental Treatment1 Intervention

Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.

Group III: Cohort A: Rencofilstat 75 mgExperimental Treatment1 Intervention

Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.

Group IV: Cohort D: PlaceboPlacebo Group1 Intervention

Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.

0 / 10Eligibility 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 lifestyle modifications, such as diet and exercise, and pharmacological interventions. Pharmacological treatments often target metabolic pathways to reduce liver fat and inflammation. For instance, pioglitazone improves insulin sensitivity, and GLP-1 receptor agonists like liraglutide reduce liver fat and inflammation. Antifibrotic agents, such as those being studied in the trial for Rencofilstat, aim to directly reduce liver fibrosis by inhibiting pathways that lead to the activation of hepatic stellate cells, which are key players in fibrosis development. This is crucial for NAFLD patients as reducing fibrosis can prevent progression to cirrhosis and liver-related complications, thereby improving overall liver function and patient outcomes.