CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
EFX +1 moredrug
Likely dose
Efruxifermin administered by subcutaneous injectionAI-extracted
Key inclusion· 6
  • ✓Age 18–80 years at screening
  • ✓Main Study: BMI >25 kg/m² (unless biopsy-proven NASH documented within last 2 years)
  • ✓Main Study: ≥10% liver fat content on MRI-PDFF at screening
  • ✓Main Study: Liver biopsy within 180 days of randomization with fibrosis stage F1–F3, NAS ≥4 with scores ≥1 each in steatosis, ballooning degeneration, and lobular inflammation
Key exclusion· 3
  • ✕Weight gain or loss >5% in 3 months prior to randomization or >10% in 6 months prior to screening
  • ✕Type 1 diabetes or insulin-dependent Type 2 diabetes
  • ✕Uncontrolled hypertension (blood pressure >160/100 mmHg)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976401
NCT03976401Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Nonalcoholic Steatohepatitis (NASH)

Akero Therapeutics, Inc·interventional·Posted Jun 6, 2019·Updated Aug 4, 2022

In Brief

A Phase 2 clinical trial evaluating EFX and Placebo for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 110 participants across 27 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartMay 28, 2019
Primary CompletionFeb 10, 2021
Study CompletionJan 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.1 years ago

Interventions

EFXdrug

Administered by subcutaneous injection

Placebodrug

Administered by subcutaneous injection