Semaglutide 1 mg demonstrated a statistically significant and superior reduction of 24% in the risk of kidney disease-related events vs. placebo in adults with type 2 diabetes and chronic kidney disease.

在患有2型糖尿病和慢性肾脏病的成年人中，与安慰剂相比，Semaglutide 1 mg在肾脏疾病相关事件的风险方面显示出统计学上显着且优越的降低24%。

Based on FLOW trial data, Novo Nordisk submitted a label extension application for Ozempic®, which has been accepted for review by the FDA.

根据流动试验数据，诺和诺德提交了Ozempic®的标签扩展申请，该申请已被FDA接受审查。

PLAINSBORO, N.J., June 24, 2024 /PRNewswire/ -- Novo Nordisk today presented the full results from FLOW, its phase 3b kidney outcomes trial investigating the effects of once-weekly injectable semaglutide 1 mg in adults with type 2 diabetes and chronic kidney disease (CKD), at the 84th Annual Scientific Sessions of the American Diabetes Association (ADA).

新泽西州普莱恩斯伯罗（PLAINSBORO，N.J.），2024年6月24日/PRNewswire/--诺和诺德（Novo Nordisk）今天在美国糖尿病协会（ADA）第84届年度科学会议上介绍了FLOW的完整结果，FLOW是其3b期肾脏结局试验，研究了每周一次注射semaglutide 1 mg对2型糖尿病和慢性肾病（CKD）成人的影响。

The double-blind, randomized, placebo-controlled trial, which enrolled 3,533 people with type 2 diabetes and CKD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo (331 vs.

这项双盲，随机，安慰剂对照试验招募了3533名2型糖尿病和CKD患者，达到了其主要终点，与安慰剂相比，semaglutide 1 mg显示肾脏疾病进展风险和心血管和肾脏死亡率降低了24%（331 vs。

410 events; hazard ratio: 0.76 [0.66; 0.88]; P=0.0003).1 The primary outcome was major kidney disease events, a composite of onset of kidney failure (initiation of long-term dialysis, kidney transplantation, or a reduction in the eGFR to <15 ml per minute per 1.73 m2 sustained for ≥28 days), a sustained (for ≥28 days) 50% or greater reduction in eGFR from baseline, or death from kidney-related or cardiovascular causes.1.

410个事件；危险比：0.76[0.66；0.88]；P=0.0003）[1]。主要终点是主要肾脏疾病事件，肾功能衰竭发作（开始长期透析，肾移植或eGFR降低至每1.73平方米每分钟15毫升持续≥28天），eGFR从基线持续（持续≥28天）降低50%或更高，或肾相关或心血管原因死亡。

'Treating serious comorbidities like chronic kidney disease is critical to improving treatment outcomes for people with type 2 diabetes. The results from the FLOW trial represent important data, as we look to better understand what GLP-1 treatment options could mean for this patient population,' said Anna Windle, PhD, senior vice president clinical development, Medical & Regulatory Affairs at Novo Nordisk.

“治疗慢性肾病等严重合并症对于改善2型糖尿病患者的治疗效果至关重要。诺和诺德医学与监管事务高级副总裁AnnaWindle博士说：“FLOW试验的结果代表了重要的数据，因为我们希望更好地了解GLP-1治疗方案对这一患者群体意味着什么。”。

'Leveraging our deep expertise in cardiometabolic science, we are proud to continue building strong clinical evidence on the strength and versatility of semaglutide to deliver results for people living with serious chronic diseases.'.

。

Additionally, the study found that semaglutide 1 mg demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including a significant reduction in the mean annual glomerular filtration rate (eGFR) slope by 1.16 ml/min/1.73 m²/year (−2.19 vs. −3.36 ml/min/1.73 m²/year [0.86; 1.47]; P<0.001).

此外，该研究发现，在评估的所有确证次要结局中，semaglutide 1 mg显示优于安慰剂，包括平均年肾小球滤过率（eGFR）斜率显着降低1.16 ml/min/1.73 m²/年（-2.19 vs.-3.36 ml/min/1.73 m²/年[0.86；1.47]；P<0.001）。

The risk of major cardiovascular events was significantly lower in the semaglutide group than in the placebo group (212 vs. 254 events; hazard ratio: 0.82; [0.68; 0.98]; P=0.029). The risk of death from any cause was significantly lower in the semaglutide group than in the placebo group (227 vs. 279 events; hazard ratio: 0.80 [0.67; 0.95]; P=0.01).1.

semaglutide组发生主要心血管事件的风险显着低于安慰剂组（212比254事件；风险比：0.82；[0.68；0.98]；P=0.029）。semaglutide组任何原因的死亡风险显着低于安慰剂组（227比279事件；风险比：0.80[0.67；0.95]；P=0.01）。

Serious adverse events were reported in fewer participants in the semaglutide group than in the placebo group (877 [49.6%] vs. 950 [53.8%]). Prespecified adverse events of special interest (≥5%) for participants in the semaglutide and placebo groups, respectively, included diabetic retinopathy (402 [22.8%] vs.

semaglutide组的参与者报告的严重不良事件少于安慰剂组（877例（49.6%），950例（53.8%）。semaglutide组和安慰剂组参与者特别感兴趣的预先指定的不良事件（≥5%）分别包括糖尿病视网膜病变（402（22.8%）vs。

398 [22.5%], Covid-19-related disorder (358 [20.3%] vs. 404 [22.9%]), serious cardiovascular disorder (273 [15.4%] vs. 319 [18.1%], heart failure (133 [7.5%] vs. 175 [9.9%]), acute kidney failure (172 [9.7% vs. 182 [10.3%]), malignant tumor (120 [6.8%] vs. 104 [5.9%]) and serious gastrointestinal disorder (95 [5.4%] vs.

398例（22.5%），新型冠状病毒相关疾病（358例（20.3%）比404例（22.9%），严重心血管疾病（273例（15.4%）比319例（18.1%），心力衰竭（133例（7.5%）比175例（9.9%），急性肾衰竭（172例（9.7%）比182例（10.3%），恶性肿瘤（120例（6.8%）比104例（5.9%））和严重胃肠道疾病（95例（5.4%）比。

94 [5.3%]). Adverse events leading to permanent discontinuation of semaglutide or placebo were more common in the semaglutide group than in the placebo group (233 [13.2%] vs. 211 [11.9%]); this finding was driven mainly by discontinuation because of gastrointestinal disorders (79 [4.5%] vs. 20 [1.1%]).1.

94（5.3%）。；这一发现主要是由于胃肠道疾病而停药（79例（4.5%）比20例（1.1%））。

Novo Nordisk stopped the FLOW study early based on a recommendation from an Independent Data Monitoring Committee due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.

诺和诺德根据独立数据监测委员会的建议提前停止了FLOW研究，因为在中位随访3.4年后符合预先规定的疗效标准。

Based on data from the FLOW clinical trial, Novo Nordisk submitted a label extension application for Ozempic®, which has been accepted for review by the U.S. Food & Drug Administration (FDA). A decision is anticipated in January 2025. Data from the FLOW trial were previously presented in May at the 61st European Renal Association Congress and simultaneously published in the New England Journal of Medicine.1.

根据FLOW临床试验的数据，诺和诺德提交了Ozempic®的标签扩展申请，该申请已被美国食品和药物管理局（FDA）接受审查。预计2025年1月将作出决定。FLOW试验的数据先前于5月在第61届欧洲肾脏协会大会上发表，并同时发表在《新英格兰医学杂志》上。

About FLOW

关于FLOW

FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing injectable semaglutide 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the risk of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD (defined as eGFR2 ≥50 and ≤75mL/min/1.73 m2 and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g).

FLOW是一项国际性，随机，双盲，平行组，安慰剂对照，事件驱动的优越性试验，比较注射用semaglutide 1 mg和安慰剂作为肾脏结局标准护理的辅助手段，以降低2型糖尿病和CKD患者肾功能不全进展风险和肾脏和心血管死亡风险（定义为eGFR2≥50和≤75mL/min/1.73 m2，UACR>300和<5000 mg/g或eGFR≥25和<50 mL/min/1.73 m2，UACR>100和<5000 mg/g）。

3,533 people (1,767 in the semaglutide group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at around 400 investigator sites. The FLOW trial was initiated in 2019.1.

3533人（塞马鲁肽组1767人，安慰剂组1766人）参加了在28个国家约400个研究地点进行的试验。流动试验于2019.1年开始。

The key objective of the FLOW trial was to demonstrate delay in the progression of CKD and a lower risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease or death from cardiovascular disease.

FLOW试验的关键目标是通过由以下五个组成部分组成的复合主要终点来证明CKD进展的延迟以及肾脏和心血管死亡的风险降低：根据CKD-EPI3方程，与基线相比，持续性eGFR（CKD-EPI）的发作<15 mL/min/1.73 m2，开始慢性肾脏替代治疗（透析或肾移植），肾脏疾病死亡或心血管疾病死亡。

Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and all-cause death.1.

确定的次要终点包括eGFR（CKD-EPI），MACE（非致命性心肌梗塞，非致命性中风，心血管死亡）和全因死亡的年变化率。

About CKD

关于CKD

CKD affects more than 800 million people worldwide2, and its prevalence is expected to rise with an aging demographic and increasing incidence of diabetes. CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.3 For people with type 2 diabetes, CKD imparts a considerable burden and is a major cause of morbidity, including increased cardiovascular risk and mortality.4.

CKD影响全球8亿多人2，随着人口老龄化和糖尿病发病率的增加，其患病率预计会上升。CKD是2型糖尿病的常见并发症，大约40%的2型糖尿病患者也患有CKD[3]。对于2型糖尿病患者，CKD带来了相当大的负担，是发病的主要原因，包括心血管风险增加和死亡率。

Despite the availability of effective therapies, a significant residual risk of CKD progression and cardiovascular events remains in people with type 2 diabetes.5

About Ozempic®

关于Ozenpic®

Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is a once-weekly glucagon-likepeptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease..

Ozempic®（semaglutide）注射液0.5 mg、1 mg或2 mg是一种每周一次的胰高血糖素样肽-1（GLP-1）受体激动剂，与饮食和运动一起使用，可改善2型糖尿病成年人的血糖（葡萄糖），并降低患有已知心脏病的2型糖尿病成年人发生心脏病发作，中风或死亡等主要心血管事件的风险。。

About Novo Nordisk

关于诺和诺德

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders.

诺和诺德是一家领先的全球医疗保健公司，100多年来一直在生产创新药物，以帮助糖尿病患者过上更长、更健康的生活。这一传统为我们提供了经验和能力，使我们能够推动变革，帮助人们战胜其他严重的慢性疾病，如肥胖、罕见血液和内分泌紊乱。

We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and commercial, production and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country.

我们坚信，持久成功的公式是保持专注，长期思考，并以对财务、社会和环境负责的方式开展业务。诺和诺德在美国新泽西州设有总部，在七个州和华盛顿特区设有商业、生产和研究设施，在全国拥有约8000名员工。

For more information, visit novonordisk-us.com, Facebook, Instagram, and X..

有关更多信息，请访问novonordisk-us.com、Facebook、Instagram和X。。

Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications..

诺和诺德致力于负责任地使用含有semaglutide的药物，这些药物代表具有不同适应症，剂量，处方信息，滴定时间表和递送形式的不同产品。这些产品不可互换，不应在其批准的适应症之外使用。。

Contacts for further information

联系方式以获取更多信息

Media:

媒体：

Allison Schneider (US) +1 732 513 4875 (Mobile)aocd@novonordisk.com

Allison Schneider（美国）+1 732 513 4875（手机）aocd@novonordisk.com

Ambre James-Brown (Global) +45 3079 9289 (Direct) abmo@novonordisk.com

Ambre James Brown（全球）+45 3079 9289（直接）abmo@novonordisk.com

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References

参考文献

Perkovic V, Tuttle KR, Rossing P, et al.. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. New England Journal of Medicine. 2024. https://doi.org/10.1056/nejmoa2403347

Perkovic V，Tuttle KR，Rossing P等人。semaglutide对2型糖尿病患者慢性肾脏疾病的影响。新英格兰医学杂志。2024https://doi.org/10.1056/nejmoa2403347

Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl. 2022. 12(1): 7–11. https://doi.org/10.1016/j.kisu.2021.11.003

Kovesdy CP.慢性肾脏病流行病学：2022年更新。肾脏国际补充。2022年。12（1）：7-11。https://doi.org/10.1016/j.kisu.2021.11.003

von Scholten BJ, Kreiner FF, Rasmussen S, Rossing P, Idorn T. (2022). The potential of GLP-1 receptor agonists in type 2 diabetes and chronic kidney disease: from randomised trials to clinical practice. Ther Adv Endocrinol Metab. 2022; 13, 20420188221112490. https://doi.org/10.1177/20420188221112490.

冯·斯科尔滕BJ，克雷纳FF，拉斯穆森S，罗辛P，伊多恩T.（2022）。GLP-1受体激动剂在2型糖尿病和慢性肾病中的潜力：从随机试验到临床实践。Ther Adv内分泌代谢。2022年；1320420188221112490。https://doi.org/10.1177/20420188221112490.

de Boer IH, Rue TC, Hall YN, et al. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011;305:2532-9.

de Boer IH，Rue TC，Hall YN等。美国糖尿病肾病患病率的时间趋势。杰玛。2011年；305:2532-9。

de Boer IH, Khunti K, Sadusky T, et al. (2022). Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes care. 2022; 45(12); 3075–3090. https://doi.org/10.2337/dci22-0027

de Boer IH，Khunti K，Sadusky T等人（2022年）。慢性肾病的糖尿病管理：美国糖尿病协会（ADA）和肾脏疾病：改善全球结果（KDIGO）的共识报告。糖尿病护理。2022年；45（12）；3075–3090。https://doi.org/10.2337/dci22-0027

Novo Nordisk is a registered trademark of Novo Nordisk A/S.© 2024 Novo Nordisk All rights reserved. US24OZM00325 June 2024

诺和诺德是诺和诺德公司的注册商标。©2024诺和诺德保留所有权利。US24OZM00325 2024年6月

SOURCE Novo Nordisk

来源诺和诺德