published results from Novo Nordisk’s phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.

诺和诺德公布的三期REDEFINE 1试验结果，评估了在患有与体重相关的健康问题但没有糖尿病的肥胖或超重成人中，使用研究性药物CagriSema联合生活方式干预减重的效果和安全性。

REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.

REDEFINE 1 达到了其共同主要终点，并在使用CagriSema的患者与安慰剂组相比，在68周时实现了具有统计学意义和临床意义的体重减轻。

These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association’s (ADA) 85th Scientific Sessions and published in

这些数据以及在超重或肥胖并患有2型糖尿病的成人中进行的相关3期REDEFINE 2研究，于今天在美国糖尿病协会（ADA）第85届科学会议的一场科学研讨会上公布，并发表在

NEJM

新英格兰医学杂志

“In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.

“在REDEFINE 1试验中，参与者根据方案实现了显著且具有临床意义的减重，该方案允许研究者在认为对患者最有利的情况下维持患者使用次最大剂量。我们还观察到，在REDEFINE 1和2中，因不良事件导致的停药率均为较低的个位数，”诺和诺德执行副总裁兼研发主管Martin Holst Lange表示。

“These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.”.

“这些结果增强了我们对CagriSema的信心，并且我们继续通过REDEFINE试验研究这种组合的潜力。”

CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment..

CagriSema 是一种将 GLP-1 受体激动剂司美格鲁肽与胰淀素类似物卡格列肽结合的在研产品。REDEFINE 1 试验发现，如果所有患者都依从治疗，使用 CagriSema 治疗在 68 周时体重减轻了 22.7%，而安慰剂组仅为 2.3%。

When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.

在不考虑依从性的情况下评估治疗效果时，接受CagriSema治疗的患者在68周时体重减轻了20.4%，而安慰剂组为3.0%，达到了统计学上的显著差异。

In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m

此外，一项支持性的次要分析显示，接受CagriSema治疗的肥胖试验参与者中有一半（50.7%）达到了非肥胖的阈值（BMI < 30 kg/m）。

) at the end of treatment, from a mean BMI of 38 kg/m

`) 在治疗结束时，BMI 从平均 38 kg/m`

at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.

在治疗开始时。在安慰剂组，10.2% 的人在 68 周时达到了该阈值。

Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.

选择确认性次要终点显示，如果所有参与者都坚持治疗，接受CagriSema治疗的患者中有40.4%体重减轻了≥25%。

Additionally, 23.1% lost ≥30% of their body weight.

此外，23.1% 的人减掉了至少 30% 的体重。

When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.

应用治疗策略估计值时，34.7%的接受CagriSema治疗的参与者体重减轻了≥25%，19.3%的参与者体重减轻了≥30%。

In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.

在对252名参与者预先指定的分析中，从基线到第68周，CagriSema治疗组的脂肪和瘦软组织质量相对减少分别为-35.7%（脂肪量）和-14.4%，而安慰剂组则分别为-5.7%和-4.3%。

'In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,” said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. “Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight.

“在REDEFINE 1研究中，CagriSema提供了现有减重干预措施中最高范围的减重效果，”主要研究者、伯明翰阿拉巴马大学医学教授兼糖尿病研究中心主任Timothy Garvey博士表示。“研究人员在剂量调整上有一些灵活性，以平衡疗效和安全性，但无论剂量如何调整，参与者都显著减重。”

These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.”.

这些发现与临床实践相关，在临床实践中，剂量常常根据个体需求和临床判断进行调整。

Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.

REDEFINE 1 和 2 试验中产生的安全性数据与 GLP-1 RA 类别相当。总体而言，因不良事件导致的停药率较低，REDEFINE 1 中 CagriSema 组为 6%，安慰剂组为 3.7%；REDEFINE 2 中 CagriSema 组为 8.4%，安慰剂组为 3%。

In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.

在REDEFINE 1研究中，不良事件主要为胃肠道反应（CagriSema组为79.6%，安慰剂组为39.9%），包括恶心（55% vs. 12.6%）、便秘（30.7% vs. 11.6%）、呕吐（26.1% vs. 4.1%），且大多为短暂性、轻至中度严重程度。

Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA’s Scientific Sessions and published in

REDEFINE 2 是一项评估CagriSema联合生活方式干预在肥胖和2型糖尿病（T2D）成人中的疗效和安全性的3期研究，其结果也在ADA科学会议期间的科学研讨会上同步发表，并刊登在

NEJM

新英格兰医学杂志

In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.

在 REDEFINE 2 研究中，如果所有参与者都坚持治疗，从基线到第68周，CagriSema组的体重平均变化估计为–15.7%，而安慰剂组为–3.1%。

When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.

应用治疗策略估计值时，从基线到第68周，卡格里塞玛组的体重平均变化为-13.7%，而安慰剂组为-3.4%。

A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by

与安慰剂相比，接受CagriSema的参与者中有更高比例的人体重减轻了。

5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).

5%（83.6% 对 30.8% 的参与者），≥10%（65.6% 对 10.3%），≥15%（43.9% 对 2.4%），以及 ≥20%（22.9% 对 0.5%）。

The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.

CagriSema在REDEFINE 2中的安全性结果与REDEFINE 1中报告的相似。

The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2.

REDEFINE临床项目将继续评估CagriSema的有效性和安全性。最近，诺和诺德于2025年6月初启动了REDEFINE 11试验，并迎来了首位患者访视。与REDEFINE 1和2相比，REDEFINE 11将通过更长的试验周期及其他方案调整，进一步探索CagriSema 2.4 mg / 2.4 mg的减重潜力和安全性。

* Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment

基于试验产品估计量；该估计量估计如果所有参与者都遵守治疗方案，效果将会如何。

** Based on the treatment policy estimand: treatment effect regardless of treatment adherence

** 基于治疗策略估计量：无论治疗依从性如何的治疗效果

About CagriSema

关于CagriSema

CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg..

CagriSema正被诺和诺德公司研究用于治疗超重或肥胖成人（REDEFINE项目）的每周一次皮下注射疗法，以及用于治疗2型糖尿病成人（REIMAGINE项目）。CagriSema是一种固定剂量组合，包含长效胰淀素类似物cagrilintide 2.4 mg和semaglutide 2.4 mg。

About the REDEFINE clinical trial programme

关于REDEFINE临床试验计划

REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.

REDEFINE 是一项关于每周一次皮下注射CagriSema治疗肥胖症的3期临床开发计划。REDEFINE 1和REDEFINE 2共招募了约4,600名超重或肥胖的成人。REDEFINE 1是一项双盲、安慰剂和活性对照的3期临床试验，为期68周，评估每周一次的CagriSema、cagrilintide 2.4 mg和semaglutide 2.4 mg相对于安慰剂在3,417名患有肥胖或超重且伴随一种或多种并发症但无2型糖尿病的成人中的疗效与安全性。

REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight..

REDEFINE 2 是一项双盲、随机、安慰剂和对照的 68 周三期临床试验，评估每周一次 CagriSema 与安慰剂在 1,206 名患有 2 型糖尿病且肥胖或超重的成人中的疗效和安全性。

Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2..

目前正在进行多项 REDEFINE 临床试验，包括：REDEFINE 3，一项以事件驱动的心血管结局的 3 期试验；REDEFINE 4，一项为期 84 周的头对头疗效与安全性 3 期试验，比较每周一次 CagriSema 与每周一次 tirzepatide；以及 REDEFINE 11，一项相较于 REDEFINE 1 和 2 具有更长持续时间和其他方案调整的 3 期试验。

About obesity

关于肥胖症

Obesity is a serious chronic, progressive, and complex disease that requires long-term management.

肥胖症是一种严重的、慢性、进行性和复杂的疾病，需要长期管理。

One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.

一个关键的误解是，这只是一种缺乏意志力的疾病，而事实上，存在可能阻碍肥胖者减肥并保持体重的潜在生物学因素。

Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.

肥胖受到多种因素的影响，包括遗传因素、健康的社会决定因素和环境因素。

About Novo Nordisk

诺和诺德公司简介

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.

诺和诺德是一家全球领先的医疗保健公司，成立于1923年，总部位于丹麦。我们的宗旨是依托在糖尿病领域的深厚积淀，推动变革以战胜严重的慢性疾病。我们通过开创科学突破、扩大药品获取渠道，以及努力预防并最终治愈疾病来实现这一目标。