NCT05039450CompletedPhase 2
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 213 (actual)
- First submitted
- 29 Jul 2021
- Start date
- 30 Jul 2021
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Akero Therapeutics, Inc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05039450
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 213
- From 30 Jul 2021 to the primary completion date, 15 Dec 2023
- 44 sites in 3 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
- 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.
- Cohort D Only: Weight loss \> 5% in the 90 days prior to screening
Other illness
- Type 1 diabetes or uncontrolled Type 2 diabetes
Other
- Cohort D Only: Presence of cirrhosis on liver biopsy
- Other inclusion and exclusion criteria may apply
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 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (44)
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.