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代谢相关脂肪性肝炎
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君圣泰医药-B(02511.HK):完成HTD1801治疗代谢相关脂肪性肝炎的IIb期临床研究
Ge Long Hui· 2026-02-05 09:03
Group 1 - The core viewpoint of the news is that Junsheng Tai Pharmaceutical-B (02511.HK) has completed a global multicenter Phase IIb clinical study of HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) [1] - The CENTRICITY trial (NCT05623189) involved 218 patients and aimed to evaluate the efficacy and safety of HTD1801 compared to a placebo in MASH patients with type 2 diabetes (T2DM) or prediabetes [1] - Preliminary analysis showed that 48% of patients in the placebo group achieved a reduction of ≥2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) without fibrosis worsening, significantly higher than previous studies where placebo effects were typically below 20% [1] Group 2 - Following a review by a third-party organization, issues were identified in the management of concomitant medications and patient compliance during the trial, which may have significantly impacted the results [2] - After excluding abnormal interference factors such as non-compliant medication use, the placebo effect was found to decrease significantly, indicating a treatment improvement trend for HTD1801 in several liver histological indicators [2] - The post-hoc analysis results suggest that the study was influenced by multiple execution and quality management factors, while HTD1801 demonstrated long-term safety and tolerability consistent with previous clinical research findings [2]