– Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo.

– 今天，诺和诺德宣布了REDEFINE 2的初步结果，这是一项属于全球REDEFINE项目的III期试验。REDEFINE 2是一项为期68周的有效性和安全性试验，研究每周一次皮下注射CagriSema（2.4毫克cagrilintide和2.4毫克semaglutide的固定剂量组合）与安慰剂的对比。

The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg..

试验包括1206名随机选择的肥胖或超重且患有2型糖尿病的人，其平均基线体重为102公斤。

The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo.

该试验达到了其主要终点，与安慰剂相比，CagriSema在第68周时显示出统计学上显著且更优的减重效果。

The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose.

REDEFINE 2 试验基于一个灵活的方案，允许患者在试验过程中调整剂量。68 周后，接受 CagriSema 治疗的患者中有 61.9% 使用了最高剂量。

When evaluating the effects of treatment, if all people adhered to treatment

在评估治疗效果时，如果所有人都坚持治疗

, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo.

，接受CagriSema治疗的人在68周后体重减轻了15.7%，而安慰剂组仅减轻了3.1%。68周后体重减轻5%或更多是一个共同主要终点，使用CagriSema的患者中有89.7%达到了这一目标，而安慰剂组仅有30.3%达到。

When applying the treatment policy estimand

当应用处理策略估计量时

, people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo.

，接受CagriSema治疗的人体重减轻了13.7%，相比之下，安慰剂组仅为3.4%。

In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.

在试验中，CagriSema 表现出安全且耐受性良好的特性。CagriSema 最常见的不良事件是胃肠道反应，其中绝大多数为轻度至中度，并随着时间的推移而减轻，这与 GLP-1 受体激动剂类药物一致。

“The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes”, said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.”.

“REDEFINE 2 研究结果证实了CagriSema在超重或肥胖以及2型糖尿病患者中的优越疗效，”诺和诺德执行副总裁、开发主管Martin Holst Lange表示。“我们期待将这一第二项关键试验提交给监管机构，旨在让这一下一代疗法惠及数百万有需要的患者。”

Novo Nordisk expects to file for the first regulatory approval of CagriSema in the first quarter of 2026. The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025.

诺和诺德预计将在2026年第一季度提交CagriSema的首次监管审批申请。REDEFINE 1和REDEFINE 2的详细结果将在2025年的科学会议上公布。

About CagriSema

关于CagriSema

Once-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a 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.

诺和诺德正在研究每周一次皮下注射CagriSema，用于治疗成年人超重或肥胖（REDEFINE计划）以及作为成人2型糖尿病的治疗（REIMAGINE计划）。CagriSema是长效amylin类似物cagrilintide 2.4 mg与semaglutide 2.4 mg的固定剂量组合。

The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake..

这两种分子通过减少饥饿感、增加饱腹感来诱导减重，从而帮助人们减少进食量和降低热量摄入。

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. The global clinical trial programme consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes:

REDEFINE 是一项针对肥胖症的三期临床开发计划，采用每周一次皮下注射CagriSema。该全球临床试验计划包括两项关键的三期试验，已招募了大约4600名超重或肥胖的成年人。三期试验计划包括：

REDEFINE 1 – a 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.

重新定义1 – 一项为期68周的三期临床试验，评估每周一次CagriSema、cagrilintide 2.4 mg和semaglutide 2.4 mg对比安慰剂在3,417名肥胖或超重且有一种或多种合并症但无2型糖尿病的成人中的疗效与安全性。

REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight.

重新定义2 – 一项为期68周的三期临床试验，评估每周一次CagriSema与安慰剂在1200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。

REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes.

REDEFINE 3 – 一项针对7,000名已确诊心血管疾病伴或不伴2型糖尿病的成年人，每周一次CagriSema与安慰剂的事件驱动型心血管结局三期试验。

REDEFINE 4 – an 84-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity.

REDEFINE 4——一项为期84周的三期临床试验，评估每周一次CagriSema与每周一次15毫克tirzepatide在800名成年肥胖患者中的疗效和安全性。

About Novo Nordisk

关于诺和诺德

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。我们的宗旨是基于我们在糖尿病领域的传承，推动变革以战胜严重的慢性疾病。我们通过开创科学突破、扩大药品的可及性，并努力预防和最终治愈疾病来实现这一目标。

Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit .

诺和诺德在80个国家拥有约76,300名员工，并在大约170个国家销售其产品。诺和诺德的B股在纳斯达克哥本哈根证券交易所上市（Novo-B），其美国存托凭证（ADR）在纽约证券交易所上市（NVO）。欲了解更多信息，请访问。