The Phase 3 SYNCHRONY clinical trial program consists of three randomized, placebo-controlled trials:

• SYNCHRONY Histology, which is evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic (F2-F3) MASH;
• SYNCHRONY Real-World, which is assessing the safety and tolerability of EFX in patients with noninvasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4);
• SYNCHRONY Outcomes, which is evaluating EFX for the treatment of compensated cirrhosis (F4) due to MASH.

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.