What is the Purpose of this Study?
The purpose of this study is to determine the safety and effectiveness of an investigational drug called efruxifermin (EFX) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) that has not progressed to cirrhosis. NASH/MASH is a type of fatty liver disease that can cause inflammation and scarring in the liver over time. Researchers are studying whether EFX may help improve liver health, reduce inflammation, and improve or reverse liver scarring. Participants in this study will be randomly assigned to 1 of 3 dose groups to receive either placebo or 1 of 2 dose levels of EFX. The study drug is given as a once-weekly injection under the skin with a primary treatment period of 52 weeks. Participants will receive training on how to give the injection themselves, or with the help of a caregiver, at home. Study procedures include blood draws, physical exam, vital signs, liver biopsies, electrocardiogram (ECG), ultrasound, imaging, injections of study medication, and completion of questionnaires. Study-related procedures and the study drug will be provided at no cost to participants.
Eligibility
- * Males and non-pregnant, non-lactating females between 18 - 80 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.
- * Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 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:
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A PHASE 3 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS NASH METABOLIC DYSFUNCTIONASSOCIATED STEATOHEPATITIS MASH AND FIBROSIS