Ozempic®（司美格鲁肽）注射液1毫克在针对患有2型糖尿病和外周动脉疾病（PAD）成人的3期STRIDE试验中显示出改善的功能结果和健康相关生活质量，该研究将在ACC 2025上发布-动脉网

Ozempic® (semaglutide) injection 1 mg showed improved functional outcomes and health-related quality of life in Phase 3 STRIDE trial in adults with type 2 diabetes and peripheral artery disease (PAD) presented at ACC 2025

CISION 等信源发布 2025-03-29 22:30

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可切换为仅中文



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

Semaglutide 1 mg demonstrated statistically significant and superior improvement in maximum walking distance by 13% over placebo in adults with type 2 diabetes and symptomatic PAD

Semaglutide 1 mg 在成人2型糖尿病和症状性PAD患者中，与安慰剂相比，最大步行距离显著提高了13%，展现出统计学上的显著性和优越性。

Based on STRIDE trial data, presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo while simultaneously published today in

基于STRIDE试验数据，该数据在美国心脏病学会（ACC）年度科学会议和博览会上发表，同时在今天出版。

The Lancet

柳叶刀

，

Novo Nordisk submitted a label extension application accepted for review by the FDA

诺和诺德提交的标签扩展申请已被FDA接受审查。

Approximately 12 million people in

大约有1200万人在

the United States

美国

are impacted by PAD, a form of atherosclerotic disease, and one in four also have type 2 diabetes

受到PAD（一种动脉粥样硬化疾病）影响，其中四分之一还患有2型糖尿病。

2,3

PLAINSBORO, N.J.

普兰斯伯罗，新泽西州

，

March 29, 2025

2025年3月29日

/PRNewswire/ -- Novo Nordisk today presented results from STRIDE, its phase

/PRNewswire/ -- 诺和诺德今日公布了其三期临床试验STRIDE的结果

trial investigating the effects of once-weekly Ozempic

每周一次 Ozempic 的效果调查试验

(semaglutide) injection 1 mg in adults with type 2 diabetes and early-stage symptomatic PAD

司美格鲁肽注射液 1 mg，用于患有 2 型糖尿病和早期症状性 PAD 的成人

, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo. The results were presented during a late-breaking clinical trial session and highlighted at an official ACC press conference. In addition, the analysis was also simultaneously published today in

，在美国心脏病学会（ACC）年度科学会议及展览会上发布。结果在一场备受关注的临床试验会议上公布，并在ACC官方新闻发布会上重点介绍。此外，该分析结果还在今天同步发表于

The Lancet

柳叶刀

。

The double-blind, randomized, placebo-controlled STRIDE trial, which enrolled 792 adults with type 2 diabetes and symptomatic PAD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 13% superior improvement in maximum walking distance (estimated treatment ratio [ETR] vs placebo, 1.13; 95% confidence interval [CI], 1.06 to 1.21; p=0.0004) and a clinically meaningful median treatment difference of 26.4 meters (95% CI, 11.8 to 40.9; approximately 87 feet, or about a third the length of an American football field) on a 12% incline, compared to placebo at 52 weeks.

STRIDE试验是一项双盲、随机、安慰剂对照试验，纳入了792名患有2型糖尿病和症状性PAD的成年人，达到了其主要终点。结果显示，1毫克司美鲁肽在最大步行距离上显示出13%的显著改善（与安慰剂相比的估计治疗比[ETR]为1.13；95%置信区间[CI]，1.06至1.21；p=0.0004），并在12%坡度下，与安慰剂相比，在52周时实现了具有临床意义的中位治疗差异，达到26.4米（95% CI，11.8至40.9；约87英尺，或大约相当于一个美式足球场长度的三分之一）。

The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance (ETR vs placebo 1.11; 95% CI, 1.03 to 1.20; p=0.0046) and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) (estimated treatment difference vs placebo 1.00; 95% CI, 0.48 to 1.52; p=0.011) at 52 weeks..

试验还显示，在所有确认性的次要终点上均优于安慰剂，包括无痛步行距离（ETR vs 安慰剂 1.11；95% CI，1.03 至 1.20；p=0.0046）和血管生活质量问卷-6（VascuQoL-6）（估计治疗差异 vs 安慰剂 1.00；95% CI，0.48 至 1.52；p=0.011）在 52 周时。

1,4

1，4

'Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks—such as retrieving the mail—challenging. In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments.

外周动脉疾病（PAD）可能导致严重症状、身体功能受限以及生活质量下降，常常使即便是短距离步行（如取邮件）也变得困难。对于同时患有PAD和糖尿病的患者，病情可能更为严重，影响小血管并限制血运重建手术及其他治疗的效果。

Semaglutide 1 mg is the first medication in over two decades to show meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes,' said .

“司美格鲁肽 1 毫克是二十多年来首个在功能能力和生活质量方面显示出显著改善的药物，这可能会解决同时患有 PAD 和 2 型糖尿病患者的关键未满足需求。”

Marc P. Bonaca

马克·P·博纳卡

, MD, Director of Vascular Research,

医学博士，血管研究主任，

University of Colorado

科罗拉多大学

School of Medicine, Lead Investigator of the STRIDE trial. 'The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population.'.

医学院，STRIDE试验的首席研究员。‘在STRIDE试验中，使用1毫克司美鲁肽观察到的步行距离显著改善和患者报告的生活质量提高是令人鼓舞的，代表了推进这一患者群体治疗选择的重要一步。’

PAD is a form of atherosclerotic cardiovascular disease that is under screened, under diagnosed, and is associated with limited walking ability and poor health-related quality of life (QoL).

PAD是一种动脉粥样硬化性心血管疾病，存在筛查不足、诊断不足的情况，并与行走能力受限和健康相关生活质量（QoL）较差有关。

2,3

Approximately 12 million people in

大约有一千两百万人在

the United States

美国

are impacted by PAD, and one in four also have type 2 diabetes.

受到PAD影响，四分之一的人还患有2型糖尿病。

2,3

2，3

The presence of type 2 diabetes increases the incidence of PAD and accelerates disease progression and severity.

2型糖尿病的存在增加了PAD的发病率，并加速了疾病的进展和严重程度。

There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.

生活在PAD和2型糖尿病患者中，目前几乎没有专门改善功能结果的疗法，这代表了一个关键的需求。

'The results from STRIDE, the first and only dedicated PAD functional outcomes trial with a

“STRIDE 的结果，这是首个也是唯一一个专注于 PAD 功能结局的试验，

GLP-1

RA treatment, provide important clinical insights that help further our understanding and approach to cardiometabolic diseases like type 2 diabetes and peripheral artery disease,' said

类风湿关节炎治疗提供了重要的临床见解，有助于进一步加深我们对2型糖尿病和外周动脉疾病等心脏代谢性疾病的理解和治疗方法。

Michael Radin

迈克尔·拉丁

, MD, Executive Medical Director, Diabetes Medical Affairs at Novo Nordisk, Inc. 'By studying the potential of semaglutide to impact everyday living through improvements in walking and quality of life, Novo Nordisk continues to demonstrate its commitment to advancing cardiometabolic science and to improving clinical outcomes for patients.'.

医学博士，诺和诺德公司糖尿病医学事务执行医学总监表示：“通过研究司美鲁肽在改善步行和生活质量方面对日常生活的影响，诺和诺德继续展示其对推进心血管代谢科学以及改善患者临床结果的承诺。”

Serious adverse events (SAEs) were reported in 74 (19%) participants in the semaglutide arm and 78 (20%) participants in the placebo arm, and SAEs that were possibly/probably treatment-related occurred in 5 (1%) and 6 (2%) participants, respectively. The most frequent SAE across both groups was serious gastrointestinal events (2 [1%] vs 3 [1%]).

在司美鲁肽组中，74名（19%）参与者报告了严重不良事件（SAEs），在安慰剂组中，78名（20%）参与者报告了严重不良事件；可能/很可能与治疗相关的SAEs分别发生在5名（1%）和6名（2%）参与者中。两组中最常见的SAE是严重的胃肠道事件（2例[1%] vs 3例[1%]）。

SAEs leading to permanent treatment discontinuation of semaglutide or placebo were reported in 11 (2.8%) and 13 (3.3%) participants in the semaglutide and placebo groups, respectively. SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related..

在司美鲁肽和安慰剂组中，分别有11名（2.8%）和13名（3.3%）参与者因严重不良事件（SAEs）而永久停止司美鲁肽或安慰剂的治疗。在司美鲁肽和安慰剂组中，分别有3名（1%）和8名（2%）参与者因严重不良事件死亡；然而，没有任何导致死亡的严重不良事件与治疗相关。

1,4

Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic

基于STRIDE临床试验的数据，诺和诺德提交了Ozempic的标签扩展申请。

to the US Food & Drug Administration (FDA). A decision is anticipated in 2025.

美国食品和药物管理局（FDA）。预计将于2025年做出决定。

About STRIDE

关于STRIDE

STRIDE is a double-blind, randomized, placebo-controlled phase

STRIDE 是一项双盲、随机、安慰剂对照的阶段

clinical trial assessing the effect of once-weekly injectable semaglutide 1 mg, marketed as Ozempic

评估每周一次注射司美鲁肽1毫克（市场名称为Ozempic）效果的临床试验

, on functional capacity versus placebo, when both were added to standard of care. It enrolled 792 adults with type 2 diabetes and symptomatic peripheral artery disease (PAD) with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52.

，对比安慰剂对功能能力的影响，两者均在标准治疗基础上添加。该研究纳入了792名患有2型糖尿病和有症状的外周动脉疾病（PAD）的成人，这些患者在行走时出现腿部疼痛。主要终点是在第52周时，使用恒定负荷跑步机测试的接受司美鲁肽治疗的患者与安慰剂组相比的最大步行距离。

STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 (.

STRIDE 是唯一一项专注于 PAD 功能结果的试验，涉及胰高血糖素样肽 -1 (。

GLP-1

) receptor agonist.

）受体激动剂。

About PAD

关于PAD

Lower extremity peripheral artery disease (PAD) is a form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL).

下肢外周动脉疾病（PAD）是一种动脉粥样硬化性心血管疾病。其典型症状是间歇性跛行（IC），伴随步行能力受限和与健康相关的生活质量（QoL）下降。

2,5

2.5

Approximately 12 million people in

大约有1200万人

the United States

美国

are impacted by PAD, and one in four also have type 2 diabetes.

受到PAD影响，四分之一的人还患有2型糖尿病。

2,3

There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.

对于患有PAD（外周动脉疾病）和2型糖尿病的人，目前改善功能结果的疗法有限，这代表了一个关键的需求。

About Ozempic

关于Ozempic

Ozempic

奥兹姆皮克

(semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (

（司美格鲁肽）注射液 0.5 毫克、1 毫克或 2 毫克是一种每周一次的胰高血糖素样肽-1（

GLP-1

) receptor agonist indicated to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes, 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, and to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease..

）受体激动剂，用于改善成人2型糖尿病患者的血糖（葡萄糖）水平，配合饮食和运动，并降低患有已知心脏病的成人2型糖尿病患者发生主要心血管事件（如心脏病发作、中风或死亡）的风险，同时减少患有2型糖尿病和慢性肾病的成人肾病恶化、肾衰竭（终末期肾病）以及因心血管疾病导致的死亡风险。

Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic

只有诺和诺德生产FDA批准的司美格鲁肽药物，如Ozempic。

. Given the vast amount of information on knock-off or compounded semaglutide being shared in the media, it is important for healthcare professionals and patients to have the clarity and confidence in knowing what they are using has undergone rigorous review for safety, effectiveness and quality. If the label doesn't say Ozempic.

鉴于媒体上分享了大量关于仿制或复方司美格鲁肽的信息，医疗专业人员和患者必须明确并有信心地了解他们使用的产品已经过严格的安全性、有效性和质量审查。如果标签上没有写Ozempic。

, it's not FDA-approved. Learn more about the responsible use of semaglutide-containing medicines and the significant safety and health risks associated with compounded or knock-off 'semaglutide' at

，它没有获得FDA的批准。了解更多关于含司美格鲁肽药物的负责任使用以及与复方或仿制“司美格鲁肽”相关的重大安全和健康风险，请访问

semaglutide.com

。

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.

诺和诺德是一家全球领先的医疗保健公司，一个多世纪以来，一直致力于研发创新药物，帮助糖尿病患者延长寿命、提高生活质量。这一历史积淀使我们具备了经验和能力，也推动了我们在其他严重慢性疾病（如肥胖症、罕见血液病和内分泌疾病）方面助力患者战胜疾病。

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 over ten manufacturing, R&D and business locations in eight states plus Washington DC, Novo Nordisk employs approximately 10,000 people throughout the country.

我们始终坚信，持久成功的秘诀在于保持专注、着眼长远，并以财务、社会和环境负责任的方式开展业务。诺和诺德美国总部位于新泽西州，在八个州及华盛顿特区拥有十多个制造、研发和业务地点，在全美雇用约10,000名员工。

For more information, visit .

欲了解更多信息，请访问 。

novonordisk-us.com

诺和诺德美国官网

，

Facebook

，

Instagram

, and

，以及

。

Contacts for further information:

有关更多信息的联系人：

Media:

媒体：

Liz Skrbkova (US)

莉兹·斯克尔科娃（美国）

+1 609 917 0632

lzsk@novonordisk.com

lzsk@诺和诺德.com

Ambre James-Brown (Global)

琥珀·詹姆斯-布朗（全球）

+45 3079 9289

abmo@novonordisk.com

abmo@诺和诺德.com

US Media Relations

美国媒体关系

NNIMediaTeam@novonordisk.com

诺和诺德媒体团队@novonordisk.com

Investors:

投资者：

Frederik Taylor Pitter (US)

弗雷德里克·泰勒·皮特（美国）

+1 609 613 0568

fptr@novonordisk.com

fptr@诺和诺德.com

Jacob Martin Wiborg Rode

雅各布·马丁·维博格·罗德

+45 3075 5956

jrde@novonordisk.com

jrde@诺和诺德.com

Sina Meyer

新浪迈尔

+45 3079 6656

azey@novonordisk.com

azey@诺和诺德.com

Ida Schaap Melvold

艾达·沙普·梅尔沃尔德

+45 3077 5649

idmg@novonordisk.com

idmg@诺和诺德.com

Max Ung

马克斯·昂格

+45 3077 6414

mxun@novonordisk.com

mxun@诺和诺德.com

Ref

参考

erences

差异

Bonaca M, Catarig AM, Houlind K, et al. The Effect of Once-weekly Subcutaneous Semaglutide on Functional Capacity in People with Type 2 Diabetes and Peripheral Artery Disease: Primary Results from the Phase

Bonaca M, Catarig AM, Houlind K, 等。每周一次皮下注射司美格鲁肽对2型糖尿病和外周动脉疾病患者功能能力的影响：来自阶段性的主要结果

, Randomized, Placebo-Controlled, Double-Blind STRIDE Trial. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025;

随机、安慰剂对照、双盲STRIDE试验。口头报告于2025年美国心脏病学会大会科学会议及博览会呈现；

29-31 March 2025

2025年3月29日至31日

; McCormick Place Convention Center,

麦考密克会展中心，

Chicago

芝加哥

, US. Presentation 102-09.

，美国。报告102-09。

Gornik, H. L., Aronow, H. D., Goodney, P. P., et al. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/

戈尔尼克，H. L.，阿罗诺，H. D.，古德尼，P. P.，等。2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/

VESS Guideline

VESS指南

for the Management of Lower Extremity Peripheral Artery Disease. Journal of the American College of Cardiology, 83(24), 2497–2604.

《下肢外周动脉疾病管理指南。美国心脏病学会杂志，83（24），2497–2604页。》

https://doi.org/10.1016/j.jacc.2024.02.013

Barnes, J. A., Eid, M. A., Creager, M. A., & Goodney, P. P. (2020). Epidemiology and risk of amputation in patients with diabetes mellitus and peripheral artery disease. Arteriosclerosis Thrombosis and Vascular Biology, 40(8), 1808–1817. https://doi.org/10.1161/atvbaha.120.314595.

巴恩斯，J. A.，埃德，M. A.，克里格，M. A.，& 古德尼，P. P. (2020)。糖尿病和外周动脉疾病患者的截肢流行病学与风险。《动脉粥样硬化、血栓形成和血管生物学》，40(8)，1808–1817。https://doi.org/10.1161/atvbaha.120.314595。

Data on file. Novo Nordisk, Inc.;

数据存档。诺和诺德公司；

Plainsboro, NJ

新泽西州普兰斯伯勒

。

Firnhaber, J. M., & Powell, C. (

菲尔哈伯，J. M.，＆鲍威尔，C. （

2019b

2019年版

，

March 15

3月15日