M-ACCEL trial

The M-ACCEL trial is a phase IIa study that evaluated the investigational oral drug HU6 for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This trial aimed to assess the drug's efficacy in reducing liver fat and its impact on body composition over a 26-week treatment period. HU6 was tested in three daily doses: 150 mg, 300 mg, and 450 mg, alongside a placebo group for comparison.

The trial demonstrated that HU6 significantly reduced liver fat in patients with MASH. Patients receiving HU6 experienced reductions in liver fat content of 29.4%, 31.2%, and 27% for the 150 mg, 300 mg, and 450 mg doses, respectively, compared to only 6.7% in the placebo group—a statistically significant difference (P=0.005). More than half of the patients on HU6 achieved at least a 30% reduction in liver fat, far exceeding the 22% response rate in the placebo group. Importantly, these reductions occurred without loss of skeletal muscle mass, which is critical for managing weight-related liver diseases.

Additionally, HU6 impacted body composition, with the 450-mg dose leading to significant fat loss (–2.4 kg) compared to placebo (–0.9 kg). Muscle mass remained stable across all HU6 groups. HU6 functions as a controlled metabolic accelerator, increasing mitochondrial energy usage, and offers a promising oral treatment option for MASH with mild side effects and good safety profiles.