Phase III SYNCHRONY Enrollment Complete

This Real-World study is evaluating the safety and tolerability of EFX in a double-blind cohort of 601 patients with MASH and MASLD.

“Completion of enrollment in the double-blind portion of the SYNCHRONY Real-World study in just over a year is a testament to the significant need for differentiated MASH treatments and growing enthusiasm around EFX’s development,” said Kitty Yale, chief development officer. “We are encouraged by the strength of data across our Phase II studies, in which improvements in liver histology and multiple non-invasive markers of liver health have been observed. We look forward to reporting results from SYNCHRONY Real-World – our first Phase III  results – in the first half of next year.”

SYNCHRONY Real-World is a Phase III randomized, double-blind, placebo controlled study evaluating the safety and tolerability of EFX in patients with suspected or confirmed clinical diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD, fibrosis stages F1-F4. The study includes an open-label cohort of patients previously assigned to placebo in the Phase IIb HARMONY or SYMMETRY studies. Enrolled patients are receiving once-weekly subcutaneous dosing of either 50mg EFX or placebo. Primary endpoints for the blinded portion of the study include assessments of the safety and tolerability of EFX during 52 weeks of treatment. Secondary endpoints for the blinded portion of the study include changes from baseline in non-invasive markers of liver fibrosis and liver injury, as well as lipoproteins, glycemic control, and body weight.

Results from the SYNCHRONY Real-World study are anticipated in the first half of 2026.