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A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

NCT03976401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-08-04

Study results available
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Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

EFX

Administered by subcutaneous injection

DRUG

Placebo

Administered by subcutaneous injection

Sponsors & Collaborators

  • Akero Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2021-02-10
Completion
2022-01-10
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976401 on ClinicalTrials.gov