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6-K: Oral Semaglutide Demonstrates a 14% Reduction in Risk of Major Adverse Cardiovascular Events in Adults with Type 2 Diabetes in the SOUL Trial

6-K: Oral Semaglutide Demonstrates a 14% Reduction in Risk of Major Adverse Cardiovascular Events in Adults with Type 2 Diabetes in the SOUL Trial

6-K：在SOUL试验中，口服西玛鲁肽显示2型糖尿病成年人发生重大心血管不良事件的风险降低了14％
美股SEC公告 ·  10/21 08:34

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Novo Nordisk A/S, a leading global healthcare company, announced on October 21, 2024, the successful results of the SOUL cardiovascular outcomes trial. The trial, which enrolled 9,650 participants with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD), demonstrated a 14% reduction in the risk of major adverse cardiovascular events (MACE) for those treated with oral semaglutide compared to placebo. This primary endpoint included cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The trial's findings, which also confirmed the safety and tolerability of oral semaglutide, are expected to support regulatory approval for a label expansion of Rybelsus® in the US and EU. Detailed results from the SOUL trial will be presented at a scientific conference in 2025. Novo Nordisk plans to file for the label expansion around the turn of the year.
Novo Nordisk A/S, a leading global healthcare company, announced on October 21, 2024, the successful results of the SOUL cardiovascular outcomes trial. The trial, which enrolled 9,650 participants with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD), demonstrated a 14% reduction in the risk of major adverse cardiovascular events (MACE) for those treated with oral semaglutide compared to placebo. This primary endpoint included cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The trial's findings, which also confirmed the safety and tolerability of oral semaglutide, are expected to support regulatory approval for a label expansion of Rybelsus® in the US and EU. Detailed results from the SOUL trial will be presented at a scientific conference in 2025. Novo Nordisk plans to file for the label expansion around the turn of the year.
全球领先的健康保健公司诺和诺德（Novo Nordisk A/S）于2024年10月21日宣布，SOUL心血管结局试验取得成功的结果。该试验共招募了9,650名患有2型糖尿病并伴有心血管疾病（CVD）和/或慢性肾病（CKD）的参与者，结果显示口服塞马谷胱甘肽治疗组的主要不良心血管事件（MACE）风险降低了14%，与安慰剂组相比。这一主要终点包括心血管死亡、非致命性心肌梗死或非致命性中风。该试验结果还确认了口服塞马谷胱甘肽的安全性和耐受性，预计将支持Rybelsus®在美国和欧盟扩展使用许可的监管批准。SOUL试验的详细结果将于2025年在一场科学会议上进行介绍。诺和诺德计划在年底前申请标签扩展。
全球领先的健康保健公司诺和诺德（Novo Nordisk A/S）于2024年10月21日宣布，SOUL心血管结局试验取得成功的结果。该试验共招募了9,650名患有2型糖尿病并伴有心血管疾病（CVD）和/或慢性肾病（CKD）的参与者，结果显示口服塞马谷胱甘肽治疗组的主要不良心血管事件（MACE）风险降低了14%，与安慰剂组相比。这一主要终点包括心血管死亡、非致命性心肌梗死或非致命性中风。该试验结果还确认了口服塞马谷胱甘肽的安全性和耐受性，预计将支持Rybelsus®在美国和欧盟扩展使用许可的监管批准。SOUL试验的详细结果将于2025年在一场科学会议上进行介绍。诺和诺德计划在年底前申请标签扩展。
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