A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

Akero Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: EFX; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039450

AK-US-001-0103

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
• Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
• Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
• Cohort D Only: Diagnosis of type 2 diabetes
• Cohort D Only: Use of GLP-1R agonist for at least 90 days
• Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3

Exclusion criteria

• Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
• Type 1 diabetes or uncontrolled Type 2 diabetes
• Cohort D Only: Weight loss > 5% in the 90 days prior to screening
• Cohort D Only: Presence of cirrhosis on liver biopsy

Other inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 5 patient groups, including a placebo group

EFX 28 mg (Main Study)

Experimental group

Treatment:

Drug: EFX

EFX 50 mg (Main Study)

Experimental group

Treatment:

Drug: EFX

Placebo (Main Study)

Placebo Comparator group

Treatment:

Drug: Placebo

EFX 50 mg (Cohort D)

Experimental group

Treatment:

Drug: EFX

Placebo (Cohort D)

Placebo Comparator group

Treatment:

Drug: Placebo