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Our Clinical Trials

We have designed a comprehensive clinical development program to deliver EFX, if approved, as quickly as possible to patients in need.

We believe our clinical trial data, which include some of the largest and most consistent effects reported to date in the MASH space, position EFX to be a potentially best-in-class treatment, if approved, for MASH. To date, data from a suite of completed and ongoing clinical studies have demonstrated that EFX has the potential to improve key indicators, including sustained improvements in liver fat and markers of liver injury, fibrosis, and key metabolic biomarkers.

We currently are enrolling three clinical trials as part of our Phase 3 SYNCHRONY program evaluating EFX for the treatment of pre-cirrhotic (F2-F3) MASH 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.

Table illustrating the status, endpoints, treatment duration, and doses in Akero’s clinical trials

SYNCHRONY

STATUS: ongoing
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.

SYMMETRY

STATUS: completed
The 96-week Phase 2b SYMMETRY study was 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. Preliminary topline results of the study demonstrated statistically significant reversal of fibrosis following 96 weeks of treatment with EFX. Among patients with baseline and week 96 biopsies (N=134), 39% of patients treated with 50mg EFX (p<0.01) experienced reversal of cirrhosis with no worsening of MASH, compared with 15% for placebo. By ITT analysis (N=181), with all missing week 96 biopsies treated as failures and without imputation, 29% of the 50mg EFX group (p<0.05) experienced reversal of cirrhosis with no worsening of MASH, compared with 12% for placebo. Histologically confirmed cirrhosis reversal was corroborated by improvements in key noninvasive measures of liver fibrosis and injury. Read more about the topline results of the study.
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Interested in participating in one of our clinical studies?

Information for Patients