HighTide Therapeutics, Inc. (Stock Code: 2511) announced the completion of its Phase IIb global multi-regional clinical trial for HTD1801 in patients with metabolic dysfunction-associated steatohepatitis (MASH) who also have type 2 diabetes mellitus or pre-diabetes. This randomized, double-blind, placebo-controlled trial, designated CENTRICITY (NCT05623189), enrolled 218 participants.

Preliminary analysis showed that 48% of patients in the placebo group achieved a reduction in NAFLD Activity Score of at least two points without worsening fibrosis or resolution of MASH without worsening fibrosis—substantially higher than the placebo effect observed in similar trials, which typically does not exceed 20% according to a systematic review and meta-analysis published in 2025.

Subsequent investigation identified issues relating to study execution and quality management, including significant differences in the use of concomitant medications between the placebo and treatment groups. A post hoc analysis that controlled for such confounding factors indicated a markedly lower placebo rate and a trend of therapeutic improvement for HTD1801 across multiple liver histological measures. The study also confirmed the drug’s long-term safety and tolerability, consistent with previous clinical findings.

The company will further assess the data and post hoc conclusions, remain in contact with the U.S. Food and Drug Administration for feedback, and determine its future clinical development strategy for the MASH indication.