玛仕度肽与司美格鲁肽第二次头对头三期研究（GLORY-3）在中国完成首例成年超重或肥胖伴脂肪肝疾病患者的给药-动脉网

Second Head-to-head Phase 3 Study of Mazdutide versus Semaglutide Completes First Participant Dosing in Adults in China with Overweight or Obesity Accompanied Fatty Liver Disease (GLORY-3)

CISION 等信源发布 2025-05-16 08:00

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可切换为仅中文

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



SAN FRANCISCO

旧金山

and SUZHOU,

和苏州，

China

中国

，

May 15, 2025

2025年5月15日

/PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in GLORY-3, a Phase 3 clinical study of mazdutide (Innovent R&D Code: IBI362), a dual glucagon (GCG) and glucagon-like peptide 1 receptor (.

/PRNewswire/ -- 信达生物制药集团（“信达生物”）（港交所代码：01801），一家致力于开发、生产和销售用于治疗肿瘤、自身免疫、心血管和代谢疾病、眼科及其他重大疾病的高质量药物的世界级生物制药公司，宣布在GLORY-3的III期临床研究中，首位受试者已成功接受给药。该研究涉及双靶点胰高血糖素（GCG）和胰高血糖素样肽-1受体（研发代号：IBI362，通用名：玛仕度肽）。

GLP-1

) receptor agonist. The study targets adults in

) 受体激动剂。该研究针对成年人

China

中国

with overweight or obesity accompanied metabolic dysfunction-associated fatty liver disease (MAFLD).

伴有超重或肥胖相关的代谢功能障碍性脂肪肝病（MAFLD）。

GLORY-3 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06884293) comparing the efficacy and safety of mazdutide versus semaglutide in Chinese adults with overweight or obesity accompanied MAFLD. This study plans to enroll approximately 470 participants with overweight or obesity (BMI ≥ 27 kg/m.

GLORY-3是一项多中心、随机、开放标签的3期临床研究（NCT06884293），比较了玛珠单抗与司美格鲁肽在中国伴有MAFLD的超重或肥胖成人中的疗效和安全性。该研究计划招募约470名超重或肥胖（BMI ≥ 27 kg/m²）的参与者。

) accompanied MAFLD, who will be randomized 1:1 to receive mazdutide 9 mg or semaglutide 2.4 mg. The primary endpoints are the percentage change in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction (MRI-PDFF) and the percentage change in body weight from baseline to week 48..

）伴随MAFLD，患者将被随机1:1分配接受马祖杜肽9毫克或司美格鲁肽2.4毫克。主要终点是从基线到第48周，通过磁共振质子密度脂肪分数（MRI-PDFF）测量的肝脂肪含量（LFC）的百分比变化以及体重的百分比变化。

A Phase 2 study conducted in Chinese adults with obesity (BMI ≥ 30 kg/m

一项在中国肥胖成人（BMI ≥ 30 kg/m²）中进行的2期研究

, NCT04904913) showed that after 48 weeks of treatment,

，NCT04904913）显示，在治疗48周后，

mazdutide 9 mg achieved an 18.6% (17.8kg) placebo-adjusted mean percent reduction in body weight.

玛仕度肽9 mg实现了体重平均百分比减少18.6%（17.8公斤），已调整安慰剂效应。

Meanwhile, 51.2% and 34.9% of the subjects in the mazdutide 9 mg group achieved 15% or more and 20% or more weight loss from baseline, respectively. Among participants with baseline LFC≥ 5% (measured by MRI-PDFF),

同时，玛仕度肽9 mg组中分别有51.2%和34.9%的受试者体重较基线下降了15%及以上和20%及以上。在基线LFC≥5%（通过MRI-PDFF测量）的参与者中，

the percent change in LFC from baseline to week 24 was reduced by 73.3% in the mazdutide 9 mg group.

在mazdutide 9 mg组中，LFC从基线到第24周的百分比变化减少了73.3%。

This decrease was sustained during the 48-week extended treatment period, suggesting that

这种下降在48周的延长治疗期间得以维持，表明

mazdutide

玛仕度肽

can effectively reduce body weight and liver fat in participants with overweight or obesity.

可以有效减轻超重或肥胖参与者的体重和肝脏脂肪。

Professor

教授

Lixin Guo

郭立新

, the Principal Investigator of the Study, Peking University People's Hospital,

北京大学人民医院研究项目首席研究员，

stated, 'MAFLD is now the most common chronic liver disease in the world and has surpassed viral hepatitis as the leading chronic liver disease in

声明说：“MAFLD现在是世界上最常见的慢性肝病，已经超过病毒性肝炎成为主要的慢性肝病。

China

中国

. Obesity is a key risk factor, with MAFLD affecting up to 81.8% people with obesity in

。肥胖是一个关键的风险因素，MAFLD影响高达81.8%的肥胖人群

China

中国

[1]

. The latest Chinese guidelines recommended

。最新的中国指南推荐

GLP-1

agents such as semaglutide for treating obesity and MAFLD ('Guideline for chronic weight management and clinical practice of anti-obesity medications'). As a dual GCG/

如用于治疗肥胖和MAFLD的司美格鲁肽等药物（“慢性体重管理及抗肥胖药物临床实践指南”）。作为一种双重GCG/

GLP-1

receptor agonist, mazdutide 9 mg has shown strong weight loss effects and notable improvements in liver fat and enzyme levels, thanks to its additional GCG activity. GLORY-3 is the first clinical trial comparing a dual GCG/

受体激动剂玛仕度肽9 mg展现了显著的减重效果，并且由于其额外的GCG活性，在肝脏脂肪和酶水平方面有明显改善。GLORY-3是首个比较双重GCG/的临床试验。

GLP-1

receptor agonist with a GLP-1R-only drug in Chinese adults with obesity. It will compare the efficacy and safety of mazdutide 9 mg versus semaglutide 2.4 mg in participants with overweight or obesity accompanied MAFLD. Together with our investigator team, I am committed to conducting this study to the highest standards and to delivering a better treatment option for the Chinese population with overweight or obesity accompanied MAFLD.'.

在中国肥胖成人中，将受体激动剂与仅作用于GLP-1R的药物进行比较。本研究将会对比玛祖肽9 mg与司美鲁肽2.4 mg在超重或肥胖并伴有MAFLD的参与者中的疗效和安全性。我与我们的研究团队一起，致力于以最高标准开展这项研究，并为中国的超重或肥胖并伴有MAFLD人群提供更好的治疗选择。

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent

礼千博士，信达生物临床开发高级副总裁

, stated, 'Mazdutide, as a dual GCG/

，指出：“玛仕度肽作为一种双重GCG/

GLP-1

receptor agonist, enhances lipolysis and fatty acid oxidation by stimulating the GCG receptor, offering a series of comprehensive metabolic benefits compared to

受体激动剂，通过刺激GCG受体增强脂肪分解和脂肪酸氧化，相较于其他方法提供了一系列全面的代谢益处。

GLP-1

single receptor agonist drugs. In our Phase 2 study conducted in Chinese adults with obesity, participants with baseline LFC ≥ 5% had a 73.3% reduction in liver fat content after 24 weeks of treatment with mazdutide 9 mg, which preliminarily demonstrated the efficacy of

单一受体激动剂药物。在我们针对中国肥胖成人开展的2期研究中，基线LFC≥5%的参与者在使用玛仕度肽9 mg治疗24周后，肝脏脂肪含量减少了73.3%，初步证明了其疗效。

mazdutide

玛仕度肽

in reducing liver fat content. I am very confident that

在减少肝脏脂肪含量方面。我非常有信心

mazdutide

玛仕度肽

will continue to show strong clinical efficacy in the GLORY-3 study, including in weight loss and liver metabolism, and provide a better treatment option for Chinese patients with overweight or obesity accompanied MAFLD.'

在GLORY-3研究中，将继续展现强大的临床疗效，包括减重和肝脏代谢方面，并为伴有MAFLD的中国超重或肥胖患者提供更好的治疗选择。

About Obesity

关于肥胖症

China

中国

has the world's largest population of people with overweight or obesity

拥有世界上最多的超重或肥胖人口

[2]

, with the obesity rate likely to rise. Obesity contributes to multiple comorbidities, reducing life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths related from chronic non-communicable diseases in

，肥胖率可能还会上升。肥胖会导致多种并发症，降低生活 expectancy 和生活质量。2019年，超重和肥胖占慢性非传染性疾病相关死亡的11.1%。

China

中国

, a significant increase from 5.7% in 1990

，比1990年的5.7%显著增加

[3]

。

As obesity is a chronic disease, it requires long-term management, and

由于肥胖是一种慢性疾病，因此需要长期管理，并且

China

中国

faces a lack of long-term effective and safe treatments. Despite lifestyle interventions being the first-line treatment, many patients fail to achieve their desired weight loss goals, underscoring the need for more effective and safer pharmacological interventions.

面临缺乏长期有效且安全的治疗。尽管生活方式干预是一线治疗方法，但许多患者仍无法达到理想的减重目标，这凸显了对更有效且更安全的药物干预的需求。

About MAFLD

关于MAFLD

MAFLD is the most common chronic liver disease worldwide, with a global prevalence estimated around 32.4% and increasing. Obesity is one of the risk factors for MAFLD, and the prevalence of MAFLD in those with obesity worldwide has reached 75.3%. In

MAFLD是全球最常见的慢性肝病，全球患病率估计约为32.4%且正在上升。肥胖是MAFLD的风险因素之一，全球肥胖人群中MAFLD的患病率已达到75.3%。在

China

中国

, MAFLD has overtaken viral hepatitis as the leading chronic liver condition, affecting 81.8% of obese individuals

，MAFLD已经超过病毒性肝炎成为主要的慢性肝病，影响着81.8%的肥胖人群

[

。

China

中国

also has the world's highest incidence of MAFLD in both normal and obese populations. Treatment goals include reducing body weight and waist circumference, improving insulin resistance, preventing and treating metabolic-related syndromes, and reversing fibrosis. For patients with MAFLD and overweight or obesity, combining lifestyle and pharmacological interventions is considered the most effective strategy to improve health outcomes and quality of life..

此外，其代谢相关脂肪性肝病（MAFLD）在正常体重和肥胖人群中均为世界最高发病率。治疗目标包括减轻体重和腰围、改善胰岛素抵抗、预防和治疗代谢相关综合征以及逆转纤维化。对于伴有MAFLD且超重或肥胖的患者，结合生活方式干预和药物治疗被认为是最有效的策略，可改善健康结局和生活质量。

About Mazdutide (IBI362)

关于玛仕度肽（IBI362）

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in

信达与礼来公司就 GLP-1R 和 GCGR 双重激动剂 OXM3（也称为 mazdutide）的开发和潜在商业化签订了独家许可协议，

China

中国

. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of

作为一种哺乳动物氧肠素（OXM）类似物，mazdutide 可能提供超出以下的额外益处

GLP-1

receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies.

受体激动剂——例如促进胰岛素分泌、降低血糖和减少体重——同时通过激活胰高血糖素受体来增加能量消耗并改善肝脏脂肪代谢。玛仕度肽在临床研究中展现了出色的减重和降糖效果。

It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity..

它在减少腰围、血脂、血压、血尿酸、肝酶和肝脏脂肪含量以及改善胰岛素敏感性方面也显示出益处。

Mazdutide currently has two NDAs accepted for review by NMPA, including:

玛仕度肽目前有两个新药上市申请（NDA）被中国国家药品监督管理局（NMPA）受理并正在审评中，包括：

For chronic weight management in adults with overweight of obesity;

用于成年人超重或肥胖的慢性体重管理；

For glycemia control in adults with type 2 diabetes.

用于控制成人2型糖尿病患者的血糖水平。

Mazdutide is currently being evaluated in six Phase 3 clinical studies, including:

目前，玛仕度肽正在六项III期临床研究中进行评估，包括：

GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity.

GLORY-1：一项针对中国超重或肥胖参与者的III期临床试验。

GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity.

GLORY-2：一项针对中国中重度肥胖患者的III期临床试验。

GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD).

GLORY-3：一项比较玛仕度肽与司美格鲁肽在中国超重/肥胖及代谢功能障碍相关脂肪肝病（MAFLD）患者中的III期临床试验。

DREAMS-1: A Phase 3 trial in treatment-naïve Chinese patients with T2D.

DREAMS-1：一项针对初治中国T2D患者的III期试验。

DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D patients with inadequate glycemic control on oral antidiabetic drugs.

DREAMS-2：一项比较玛仕度肽与度拉糖肽在中国口服降糖药控制不佳的T2D患者中的III期试验。

DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese patients with T2D and obesity.

DREAMS-3：一项比较玛仕度肽与司美格鲁肽在中国T2D和肥胖患者中的3期试验。

Among these, GLORY-1, DREAMS-1 and DREAMS-2 studies have all met their endpoints.

在这些研究中，GLORY-1、DREAMS-1 和 DREAMS-2 均已达到其终点。

In addition, several new clinical studies of mazdutide are planned, including:

此外，还计划开展多项新的玛仕度肽临床研究，包括：

A Phase 3 trial in adolescents with obesity.

青少年肥胖的第三阶段试验。

A Phase 3 trial in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity.

在中国中重度阻塞性睡眠呼吸暂停（OSA）和肥胖患者中进行的3期试验。

New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF).

新型代谢功能障碍相关脂肪性肝炎（MASH）和射血分数保留的心力衰竭（HFpEF）研究。

About Innovent

关于信达

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

信达生物是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。公司致力于发现、开发、生产和商业化针对一些最棘手疾病的创新药物。其开创性疗法治疗癌症、心血管和代谢疾病、自身免疫性疾病和眼科疾病。

Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center..

信达生物已上市15款产品，有3个新药上市申请在审评中，4项资产处于III期或关键性临床试验阶段，还有15款分子处于早期临床阶段。信达生物与超过30家全球医药公司建立了合作伙伴关系，包括礼来、赛诺菲、Incyte、Adimab、LG化学和MD安德森癌症中心。

Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit

信达恪守“始于信，达于行”的理念，致力于维护最高标准的行业规范，并通力合作推进生物制药行业的发展，从而使一流的药物能够得到广泛使用。欲了解更多信息，请访问

www.innoventbio.com

, or follow Innovent on Facebook and LinkedIn.

，或者在 Facebook 和 LinkedIn 上关注信达。

Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).

声明：（1）信达不建议使用任何未经批准的药物/适应症。

（

）

Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.

雷莫芦单抗（Cyramza）和塞尔帕替尼（Retsevmo）以及皮托布替尼（Jaypirca）由礼来公司开发。

Forward-looking statement

前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与信达相关的“预期”、“相信”、“估计”、“预计”、“意图”等词语及类似表达旨在识别某些此类前瞻性陈述。

Innovent does not intend to update these forward-looking statements regularly..

信达并无意图定期更新该等前瞻性陈述。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict.

这些前瞻性陈述是基于信达生物管理层在作出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些陈述并非对未来发展的保证，且受风险、不确定性和其他因素的影响，其中一些因素超出信达生物的控制范围并且难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、信达的竞争环境以及政治、经济、法律和社会状况的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息有重大差异。

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

信达、信达的董事和员工假设（a）没有义务更正或更新本网站中包含的前瞻性陈述；以及（b）在任何前瞻性陈述未能实现或被证明不正确的情况下不承担责任。

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参考文献

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中国

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