Efruxifermin for NASH with Cirrhosis

Recruiting at 55 trial locations

Overseen By Akero Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Akero Therapeutics, Inc

Must be taking: GLP-1R agonist

Disqualifiers: Type 1 diabetes, Uncontrolled Type 2 diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

182 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efruxifermin (EFX) or placebo in a randomized, double-blind, placebo-controlled study

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Efruxifermin
• Placebo

Trial Overview The 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.

How Is the Trial Designed?

Group I: EFX 50 mg (Main Study) Experimental Treatment 1 Intervention

Group II: EFX 50 mg (Cohort D) Experimental Treatment 1 Intervention

Group III: EFX 28 mg (Main Study) Experimental Treatment 1 Intervention

Group IV: Placebo (Main Study) Placebo Group 1 Intervention

Group V: Placebo (Cohort D) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Akero Therapeutics, Inc

Lead Sponsor

Trials

6

Recruited

3,900+