Efruxifermin for NASH with Cirrhosis

Recruiting in Palo Alto (17 mi)

+55 other locations

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 is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Research Team

Eligibility Criteria

This trial is for adults aged 18-75 with compensated cirrhosis due to NASH, which is a type of liver disease. Participants may also have Type 2 diabetes or other metabolic syndrome components like obesity. Pregnant or breastfeeding women and those with recent significant weight loss or uncontrolled diabetes are excluded.

Inclusion Criteria

I have cirrhosis from NASH confirmed by a biopsy.

My liver fibrosis is at stage 1, 2, or 3.

I have been diagnosed with type 2 diabetes.

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Exclusion Criteria

I have cirrhosis confirmed by a liver biopsy.

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

I have lost more than 10% of my weight in the last 3 months or since my liver biopsy.

See 1 more

Treatment Details

Interventions

Efruxifermin (Recombinant Protein)
Placebo (Placebo)

Trial OverviewThe study tests Efruxifermin (EFX), comparing it against a placebo in people with advanced fatty liver disease. It's conducted at multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: EFX 50 mg (Main Study)Experimental Treatment1 Intervention

Group II: EFX 50 mg (Cohort D)Experimental Treatment1 Intervention

Group III: EFX 28 mg (Main Study)Experimental Treatment1 Intervention

Group IV: Placebo (Main Study)Placebo Group1 Intervention

Group V: Placebo (Cohort D)Placebo Group1 Intervention