Your session is about to expire
← Back to Search
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 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* 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 belowTimeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Extent of exposure
Number of participants with adverse events
Number of participants with adverse events by severity
+1 moreSecondary study objectives
Change from baseline in lipoproteins
Change from baseline in markers of liver injury
Change from baseline in non-invasive marker enhanced liver fibrosis (ELF) score
+1 moreAwards & 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 Rollover)Experimental Treatment1 Intervention
Group II: EFX 50 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
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.
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.
Find a Location
Who is running the clinical trial?
Akero Therapeutics, IncLead Sponsor
5 Previous Clinical Trials
3,238 Total Patients Enrolled