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君圣泰医药-B(02511)完成HTD1801头对头达格列净治疗2型糖尿病III期临床试验患者入组

HIGHTIDE-B (02511) has completed the patient enrollment for the HTD1801 head-to-head treatment of Dapagliflozin in a phase III clinical trial for type 2 diabetes.

Zhitong Finance ·  Jan 2 04:06

HIGHTIDE-B (02511) announced that the company's independently developed intestinal and hepatic anti-inflammatory and metabolic regulator ursodeoxycholic acid...

According to the Zhito Finance APP, HIGHTIDE-B (02511) announced that the Phase III clinical trial of its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, ursodeoxycholic acid and berberine (HTD1801), targeting patients with type 2 diabetes (T2DM), has completed patient enrollment.

This trial is a randomized, double-blind, positive drug (Dapagliflozin) parallel-controlled, multicenter, non-inferiority Phase III clinical trial (HARMONY), aimed at assessing the efficacy of HTD1801 compared to Dapagliflozin in adult T2DM subjects with poor blood sugar control after metformin treatment, with the primary efficacy endpoint being the change in glycated hemoglobin relative to baseline after 24 weeks of treatment. A total of 358 subjects are planned for enrollment, and enrollment has now been completed. This Phase III trial is expected to report data in 2025.

Ursodeoxycholic acid and berberine (HTD1801) is an oral anti-inflammatory and metabolic regulator targeting the intestinal-hepatic system, being developed for the treatment of metabolic and digestive system diseases. HTD1801 is an ionic salt of ursodeoxycholic acid and berberine, representing a new molecular entity with a unique dual mechanism, exerting its biological activity by activating AMPK and inhibiting NLRP3. These two key mechanisms are associated with improvements in glucose metabolism, insulin resistance, lipid metabolism, and hepatic inflammation, providing a comprehensive solution for the treatment of complex metabolic diseases such as T2DM.

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