Clinical Trials Overview
We are currently enrolling three clinical trials as part of a Phase 3 SYNCHRONY program evaluating EFX for the treatment of pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH.
The SYNCHRONY studies build on a robust Phase 2 program and have been designed in consultation with global regulatory authorities.
SYNCHRONY
STATUS: ongoing
The Phase 3 SYNCHRONY clinical trial program consists of three randomized, placebo-controlled trials: (1) SYNCHRONY Histology, which is evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3); (2) SYNCHRONY Real-World, which is assessing the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4); and (3) SYNCHRONY Outcomes, which is evaluating EFX for the treatment of compensated cirrhosis due to MASH (F4). The SYNCHRONY Histology and SYNCHRONY Real-World studies began enrolling patients in the fourth quarter of 2023, while SYNCHRONY Outcomes began enrolling patients in the third quarter of 2024.
In all EFX Phase 3 studies, patients will self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing. This optimized formulation delivers blood levels of EFX comparable to those of the liquid formulation used in prior clinical studies.
Read more about study details at Clinicaltrials.gov: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes.
Learn more about enrolling in the SYNCHRONY Histology clinical trial.
SYMMETRY
STATUS: ongoing
The 96-week Phase 2b SYMMETRY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial that enrolled 182 patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh class A who received once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo. Patients are continuing to receive EFX or placebo for up to 96 weeks to provide additional data, including a second on-treatment biopsy at week 96. Week 96 results are expected to be reported in the first quarter of 2025.
Read more at ClinicalTrials.gov.
