What side effects are associated with this type of intervention?

Common treatments for NASH/MASH similar to Efruxifermin (EFX) include analogs of fibroblast growth factors like FGF19 and FGF21. These treatments are known to have anti-steatotic, anti-inflammatory, and anti-fibrotic effects. However, they may also present side effects such as gastrointestinal disturbances, increased liver enzymes, and potential adverse effects on lipid metabolism. For instance, in clinical trials, some patients have reported mild to moderate gastrointestinal symptoms and transient increases in liver enzymes. It is important to monitor these side effects closely during treatment.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Nonalcoholic Steatohepatitis (NASH) or Metabolic Steatohepatitis (MASH). However, several drugs are in advanced stages of clinical trials, including analogs of fibroblast growth factor 21 (FGF21) like Efruxifermin (EFX). These drugs aim to regulate lipid and glucose metabolism, reduce liver fat, and improve liver histology. Other investigational drugs include obeticholic acid, a farnesoid X receptor (FXR) agonist, and resmetirom, a thyroid hormone receptor-beta agonist, both of which have shown promise in clinical trials for improving liver function and reducing fibrosis in NASH patients.

What other types of research exist?

Promising alternatives to Efruxifermin (EFX) for NASH/MASH patients include: <ol> <li>Obeticholic Acid: A farnesoid X receptor (FXR) agonist that has shown efficacy in improving liver histology and reducing fibrosis.</li> <li></li> </ol> Lanifibranor: A pan-PPAR agonist that targets PPARα, PPARδ, and PPARγ, showing promise in reducing liver inflammation and fibrosis. 3. Resmetirom (MGL-3196): A thyroid hormone receptor-β agonist that reduces liver fat and improves liver histology. 4. Aramchol: A stearoyl-CoA desaturase 1 (SCD1) inhibitor that reduces liver fat and fibrosis. 5. Semaglutide: A GLP-1 receptor agonist that has shown potential in reducing liver fat and improving liver histology in NASH patients.

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Growth Factor

Efruxifermin for NASH

Verified Trial

Phase 3

Recruiting

Research Sponsored by Akero Therapeutics, Inc

Eligibility Criteria Checklist

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

Must have

Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.

Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called efruxifermin (EFX) to see if it can help people with specific liver conditions. These conditions are hard to treat with current methods. EFX aims to improve liver health by reducing inflammation and fat buildup in the liver.

Who is the study for?

This trial is for adults aged 18-80 with a suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD, and who have at least two components of metabolic syndrome or type 2 diabetes. It's not open to those with other liver diseases, type 1 diabetes, or unstable type 2 diabetes.

What is being tested?

The study tests Efruxifermin (EFX) against a placebo in a controlled setting where neither the participants nor the researchers know who receives the actual drug. The goal is to see if EFX can help people with certain types of fatty liver disease.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with treatments for liver conditions may include gastrointestinal discomfort, potential allergic reactions, fatigue, and changes in blood work reflecting liver function.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days 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 assess the safety and tolerability of EFX

Secondary study objectives

Change from baseline of body weight (kg)

Change from baseline of lipoproteins

Change from baseline of markers of glycemic control

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: EFX 50 mg (Open-Label)Experimental Treatment1 Intervention

Group II: EFX 50 mgExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 5Eligibility 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 Nonalcoholic Steatohepatitis (NASH) or Metabolic Steatohepatitis (MASH) include analogs of fibroblast growth factor 21 (FGF21) like Efruxifermin (EFX), which regulate lipid and glucose metabolism, reduce liver fat, and improve liver histology. This is crucial for patients as it directly targets the metabolic dysfunctions underlying the disease. Other treatments include vitamin E, which has antioxidant properties that reduce liver inflammation and fibrosis, and pioglitazone, which improves insulin sensitivity and reduces liver fat. Lifestyle modifications such as diet and exercise are also essential as they help reduce overall body fat and improve metabolic health. These treatments collectively aim to halt or reverse liver damage, thereby improving patient outcomes.

Sulforaphane ameliorates non-alcoholic fatty liver disease in mice by promoting FGF21/FGFR1 signaling pathway.Transcription factor EB inhibits non-alcoholic fatty liver disease through fibroblast growth factor 21.Fibroblast growth factor 21 deficiency exacerbates chronic alcohol-induced hepatic steatosis and injury.