A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (Harmony)

Akero Therapeutics

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Efruxifermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04767529

AK-US-001-0102

Details and patient eligibility

About

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.

Enrollment: 128 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 the screening visit.

• 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.

• FibroScan measurement > 8.5 kPa [kilopascal].

• Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

  • Steatosis (scored 0 to 3),
  • Ballooning degeneration (scored 0 to 2), and
  • Lobular inflammation (scored 0 to 3).

Exclusion criteria

• Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
• Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
• Type 1 or uncontrolled Type 2 diabetes.

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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128 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

double-blind, once-weekly subcutaneous injection

Treatment:

Drug: Placebo

Efruxifermin 28 mg

Experimental group

Description:

double-blind, once-weekly subcutaneous injection

Treatment:

Drug: Efruxifermin

Efruxifermin 50 mg

Placebo Comparator group

Description:

double-blind, once-weekly subcutaneous injection

Treatment:

Drug: Efruxifermin