NCT04767529CompletedPhase 2
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 16 Feb 2021
- Start date
- 16 Feb 2021
- Primary completion date
- 2 May 2024
- Lead sponsor
- Akero Therapeutics, Inc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04767529
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 128
- From 16 Feb 2021 to the primary completion date, 2 May 2024
- 48 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Type 1 or uncontrolled Type 2 diabetes.
- Other inclusion and exclusion criteria may apply.
Other
- Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.