Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular and metabolic benefits [1] Group 1: Clinical Trial Details - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with a non-inferiority margin of 0.4% [1] - HTD1801 achieved a least squares (LS) mean change in HbA1c of -1.12%, while the Dapagliflozin group had a change of -0.93%, showing a significant difference of -0.20% (95% CI: -0.37 to -0.03; P < 0.001) [1] Group 2: Secondary Endpoints and Safety - HTD1801 demonstrated superior results compared to Dapagliflozin in lowering LDL-C and non-HDL-C, with a significantly lower proportion of patients requiring additional or intensified statin therapy [2] - HTD1801 also showed a higher percentage of patients achieving the HbA1c < 7.0% control target and a greater reduction in Lp(a) levels [2] - The safety profile of HTD1801 is favorable, with a serious adverse event rate of 3.8% compared to 4.4% in the Dapagliflozin group, and the most common adverse events were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Group 3: Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways allows for a more precise targeting of the core pathological mechanisms of T2DM, potentially offering comprehensive clinical benefits for patients [2] - Following the positive results from the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its strong potential as a foundational treatment for cardiorenal metabolic diseases [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within this year [2]
君圣泰医药-B公布HTD1801与达格列净的头对头III期临床研究结果展现控糖优势及心血管代谢优效获益