Efruxifermin for Nonalcoholic Steatohepatitis

(Harmony Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Akero Therapeutics, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called efruxifermin to see if it can help people with a specific liver disease called NASH. The study focuses on patients whose disease has not yet progressed to cirrhosis. The medication works by reducing inflammation and fat in the liver to improve its health.

Research Team

Akero Study Director

Principal Investigator

Study Director

Eligibility Criteria

This trial is for adults aged 18-75 with non-cirrhotic NASH, a type of fatty liver disease. Participants must have certain metabolic conditions or type 2 diabetes, and a recent biopsy showing specific levels of liver damage. Those who've lost significant weight recently or have cirrhosis or uncontrolled diabetes cannot join.

Inclusion Criteria

My recent liver biopsy shows moderate fibrosis and signs of NAFLD with specific scores in steatosis, ballooning, and inflammation.

FibroScan® measurement > 8.5 kPa

I am between 18 and 75 years old and if female, not pregnant or breastfeeding.

Exclusion Criteria

I have Type 1 diabetes or my Type 2 diabetes is not under control.

I have lost more than 5% of my weight in the past 3 months or since my liver biopsy.

My liver biopsy shows I have cirrhosis.

Treatment Details

Interventions

• Efruxifermin (Fibroblast Growth Factor 21 (FGF21) Analog)
• Placebo (Drug)

Trial Overview The study tests Efruxifermin (EFX) against a placebo in subjects with F2-F3 stage NASH. It's randomized and double-blind, meaning participants are put into the EFX or placebo group by chance and neither they nor the researchers know which one they're getting.

Participant Groups

Group I: EFX 50 mg Experimental Treatment 1 Intervention

Group II: EFX 28 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Akero Therapeutics, Inc

Lead Sponsor

Trials

6

Recruited

3,900+