Open-label, Randomised, 4 Parallel-group, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjects With Obesity Using PET and MRI

This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation. To measure the occupancy of these receptors, doctors use injectable tracers. Doctors visualise the binding of the tracers to these receptors with imaging methods.
Participants are put into 4 groups randomly, which means by chance. 2 groups get BI 456906 and 2 groups get semaglutide. Semaglutide is an approved medicine for body weight reduction. For 17 weeks, participants get injections under the skin. They either get BI 456906 twice a week or semaglutide once a week. The injected doses increase in small steps. Before and after 17 weeks of treatment, the receptor occupancy is determined.
Participants are in the study for up to 6 months. At the beginning and at the end of the treatment participants stay at the study site with an overnight stay. At the beginning, the study staff trains participants how to inject the study treatment at home. Participants who get BI 456906 visit the study site 18 times and have 19 visits at home. Participants who get semaglutide visit the study site 15 times and have 6 home visits. The doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2024-06-10

申办/合作机构

Boehringer Ingelheim GmbH

NCT06352411 / Not yet recruiting临床1期

Pharmacokinetics, Safety, and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild, Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function (Mono-centric, Open-label Study With Parallel Matched-pair Design)

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.
Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.
Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects.

开始日期2024-05-08

申办/合作机构

Boehringer Ingelheim GmbH

NCT06352424 / Not yet recruiting临床1期

A Single-dose, Randomized, Placebo-controlled Phase I Study on the Effects of a Subcutaneous Dose of BI 1820237 and BI 456906, and Combination Thereof on Functional MRI Measurements in Otherwise Healthy Male and Female Individuals With Obesity/Overweight (Single-blind, Cross-over Design)

The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity.

开始日期2024-04-15

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Survodutide 相关的临床结果

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100 项与 Survodutide 相关的转化医学

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100 项与 Survodutide 相关的专利（医药）

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项与 Survodutide 相关的文献（医药）

2024-02-05·The lancet. Diabetes & endocrinology

Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.

Article

作者: Carel W le Roux ; Oren Steen ; Kathryn J Lucas ; Elena Startseva ; Anna Unseld ; Anita M Hennige

BACKGROUND:

Obesity is a widespread and chronic condition that requires long-term management; research into additional targets to improve treatment outcomes remains a priority. This study aimed to investigate the safety, tolerability, and efficacy of glucagon receptor-GLP-1 receptor dual agonist survodutide (BI 456906) in obesity management.

METHODS:

In this randomised, double-blind, placebo-controlled, dose-finding phase 2 trial conducted in 43 centres in 12 countries, we enrolled participants (aged 18-75 years, BMI ≥27 kg/m², without diabetes) and randomly assigned them by interactive response technology (1:1:1:1:1; stratified by sex) to subcutaneous survodutide (0·6, 2·4, 3·6, or 4·8 mg) or placebo once-weekly for 46 weeks (20 weeks dose escalation; 26 weeks dose maintenance). The primary endpoint was the percentage change in bodyweight from baseline to week 46. Primary analysis included the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of trial medication and who had analysable data for at least one efficacy endpoint) and was based on the dose assigned at randomisation (planned treatment), including all data censored for COVID-19-related discontinuations; the sensitivity analysis was based on the actual dose received during maintenance phase (actual treatment) and included on-treatment data. Safety analysis included all participants who received at least one dose of study drug. The trial is registered with ClinicalTrials.gov (NCT04667377) and EudraCT (2020-002479-37).

FINDINGS:

Between March 30, 2021, and Nov 11, 2021, we enrolled 387 participants; 386 (100%) participants were treated (0·6 mg, n=77; 2·4 mg, n=78; 3·6 mg, n=77; 4·8 mg, n=77; placebo n=77) and 233 (60·4%) of 386 completed the 46-week treatment period (187 [61%] of 309 receiving survodutide; 46 [60%] of 77 receiving placebo). When analysed according to planned treatment, mean (95% CI) changes in bodyweight from baseline to week 46 were -6·2% (-8·3 to -4·1; 0·6 mg); -12·5% (-14·5 to -10·5; 2·4 mg); -13·2% (-15·3 to -11·2; 3·6 mg); -14·9% (-16·9 to -13·0; 4·8 mg); -2·8% (-4·9 to -0·7; placebo). Adverse events occurred in 281 (91%) of 309 survodutide recipients and 58 (75%) of 77 placebo recipients; these were primarily gastrointestinal in 232 (75%) of 309 survodutide recipients and 32 (42%) of 77 placebo recipients.

INTERPRETATION:

All tested survodutide doses were tolerated, and dose-dependently reduced bodyweight.

FUNDING:

Boehringer Ingelheim.

2024-01-23·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity.

Article

作者: Rami A Al-Horani ; Kholoud F Aliter ; Hashem F Aliter

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity.

2023-12-27·Current diabetes reports

Polyagonists in Type 2 Diabetes Management.

Review

作者: H A Dissanayake ; N P Somasundaram

PURPOSE OF THE REVIEW:

This review summarizes the new developments in polyagonist pharmacotherapy for type 2 diabetes.

RECENT FINDINGS:

Several dual- and triple-agonists targeting different pathogenic pathways of type 2 diabetes have entered clinical trials and have led to significant improvements in glycaemia, body weight, fatty liver, and cardio-renal risk factors, with variable adverse event profiles but no new serious safety concerns. Combining agents with complementary and synergistic mechanisms of action have enhanced efficacy and safety. Targeting multiple pathogenic pathways simultaneously has led to enhanced benefits which potentially match those of bariatric surgery. Tirzepatide, cotadutide, BI456906, ritatrutide, and CagriSema have entered phase 3 clinical trials. Outcomes from published clinical studies are reviewed. Efficacy-safety profiles are heterogeneous between agents, suggesting the potential application of precision medicine and need for personalized approach in pharmacological management of type 2 diabetes and obesity. Polyagonism has become a key strategy to address the complex pathogenesis of type 2 diabetes and co-morbidities and increasing number of agents are moving through clinical trials. Heterogeneity in efficacy-safety profiles calls for application of precision medicine and need for judicious personalization of care.

127

项与 Survodutide 相关的新闻（医药）

2024-04-08

·信狐药迅

临床申请品种均默示许可| 新获批（4.1-4.6）

每周药品注册获批数据，分门别类呈现，一目了然。（4.1-4.6）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请无新药临床申请药品名称企业注册分类受理号HRS8807片上海恒瑞医药有限公司1CXHL2400091HRS8807片上海恒瑞医药有限公司1CXHL2400090XNW5004片苏州信诺维医药科技股份有限公司1CXHL2400088XNW5004片苏州信诺维医药科技股份有限公司1CXHL2400087HRS-4642注射液江苏恒瑞医药股份有限公司1CXHL2400083HP501缓释片海创药业股份有限公司1CXHL2400074HP501缓释片海创药业股份有限公司1CXHL2400073JX2105胶囊浙江京新药业股份有限公司1CXHL2400070JX2105胶囊浙江京新药业股份有限公司1CXHL2400069JX2105胶囊浙江京新药业股份有限公司1CXHL2400068JX2105胶囊浙江京新药业股份有限公司1CXHL2400067HMPL-506片和记黄埔医药(上海)有限公司1CXHL2400061HMPL-506片和记黄埔医药(上海)有限公司1CXHL2400060NH103草酸盐片江苏恩华药业股份有限公司1CXHL2400054NH103草酸盐片江苏恩华药业股份有限公司1CXHL2400053NH103草酸盐片江苏恩华药业股份有限公司1CXHL2400052NH103草酸盐片江苏恩华药业股份有限公司1CXHL2400051HRS-9231注射液上海盛迪医药有限公司1CXHL2400059HS-10504片上海翰森生物医药科技有限公司1CXHL2400035HS-10504片江苏豪森药业集团有限公司1CXHL2400034CAN2109 注射液康威(广州)生物科技有限公司1CXHL2400033LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400026LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400025LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400024LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400023LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400022LPM526000133富马酸盐胶囊绿叶嘉奥制药石家庄有限公司1CXHL2400021帕拉米韦吸入溶液朗天医药科技(武汉)有限公司2.2CXHL2400082帕拉米韦吸入溶液朗天医药科技(武汉)有限公司2.2CXHL2400081H077缓释片上海汇伦医药股份有限公司2.2CXHL2400043BCM863片上海云晟研新生物科技有限公司2.3CXHL2400094H062片上海汇伦医药股份有限公司2.3CXHL2400085H062片上海汇伦医药股份有限公司2.3CXHL2400084羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400093羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400092羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2400089盐酸伊立替康脂质体注射液石药集团欧意药业有限公司2.4CXHL2400086注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400052注射用SHR-A2102上海恒瑞医药有限公司1CXSL2400049注射用BL-M07D1成都百利多特生物药业有限责任公司1CXSL2400046注射用BL-M07D1成都百利多特生物药业有限责任公司1CXSL2400045注射用SHR-A1904上海恒瑞医药有限公司1CXSL2400040注射用SHR-A1921苏州盛迪亚生物医药有限公司1CXSL2400039注射用SHR-9839上海恒瑞医药有限公司1CXSL2400038DM919注射液丹码(苏州)生物医药科技有限公司1CXSL2400035SHR-2173注射液广东恒瑞医药有限公司1CXSL2400034注射用YL201苏州宜联生物医药有限公司1CXSL2400031人脐带间充质干细胞注射液吉林省拓华生物科技有限公司1CXSL2400023SHR-4597吸入剂广东恒瑞医药有限公司1CXSL2400022CS-101注射液正序(上海)生物医药科技有限公司1CXSL2400021SHR-4597吸入剂广东恒瑞医药有限公司1CXSL2400020阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400051SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2400050阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400048阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400041人凝血酶原复合物国药集团武汉生物制药有限公司3.4CXSL2400019注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400037仿制药申请药品名称企业注册分类受理号利多卡因丁卡因乳膏浙江孚诺医药股份有限公司3CYHL2400014盐酸艾司洛尔注射液北京民康百草医药科技有限公司3CYHS2202136国盐酸艾司洛尔注射液哈尔滨三联药业股份有限公司3CYHS2202135国注射用哌拉西林钠河北东圣科宇医药科技有限公司3CYHS2201894国尼麦角林片福安药业集团庆余堂制药有限公司3CYHS2201795国复方α-酮酸片上海郅见生物医药技术有限公司3CYHS2201716国醋酸钠林格葡萄糖注射液安徽丰原药业股份有限公司3CYHS2201629国注射用氨苄西林钠广西炜焯医药科技有限公司3CYHS2201580国氨甲环酸注射液华夏生生药业(北京)有限公司3CYHS2201478国氨甲环酸注射液华夏生生药业(北京)有限公司3CYHS2201477国盐酸利多卡因注射液石家庄四药有限公司3CYHS2201460国盐酸利多卡因注射液石家庄四药有限公司3CYHS2201459国盐酸利多卡因注射液石家庄四药有限公司3CYHS2201458国盐酸左沙丁胺醇雾化吸入溶液山东禾琦制药有限公司3CYHS2201392国盐酸左沙丁胺醇雾化吸入溶液山东禾琦制药有限公司3CYHS2201391国依巴斯汀口服溶液江苏联环药业股份有限公司3CYHS2201240国头孢呋辛酯干混悬剂石家庄四药有限公司3CYHS2201222国头孢呋辛酯干混悬剂石家庄四药有限公司3CYHS2201221国盐酸左沙丁胺醇雾化吸入溶液浙江恒研医药科技有限公司3CYHS2201211国盐酸左沙丁胺醇雾化吸入溶液浙江恒研医药科技有限公司3CYHS2201210国酒石酸布托啡诺注射液成都苑东生物制药股份有限公司3CYHS2201102国酒石酸布托啡诺注射液成都苑东生物制药股份有限公司3CYHS2201101国利伐沙班颗粒江西施美药业股份有限公司3CYHS2200991国叶酸片森淼(山东)药业有限公司3CYHS2200860国硝呋太尔制霉菌素阴道软胶囊株洲千金药业股份有限公司4CYHL2400026洛索洛芬钠贴剂湖南及正医药科技有限公司4CYHL2400009洛索洛芬钠贴剂湖南及正医药科技有限公司4CYHL2400008乙酰半胱氨酸泡腾片江西青峰药业有限公司4CYHS2300427替格瑞洛片浙江诺得药业有限公司4CYHS2300198替格瑞洛片浙江诺得药业有限公司4CYHS2300197丙戊酸钠口服溶液湖南省湘中制药有限公司4CYHS2300168西格列汀二甲双胍片(II)浙江九洲生物医药有限公司4CYHS2202119国注射用达托霉素海南合瑞制药股份有限公司4CYHS2202076国吲达帕胺片浙江京新药业股份有限公司4CYHS2202053国利托那韦片安徽贝克生物制药有限公司4CYHS2202028国西格列汀二甲双胍片(I)重庆圣华曦药业股份有限公司4CYHS2201823国吸入用乙酰半胱氨酸溶液合肥国药诺和药业有限公司4CYHS2201809国盐酸乌拉地尔注射液苏州朗科生物技术股份有限公司4CYHS2201587国注射用艾司奥美拉唑钠悦康药业集团股份有限公司4CYHS2201515国舒更葡糖钠注射液上海汇伦江苏药业有限公司4CYHS2201201国他达拉非片浙江领创优品药业有限公司4CYHS2200785国他达拉非片浙江领创优品药业有限公司4CYHS2200784国卡培他滨片山东新时代药业有限公司4CYHS2200624国盐酸莫西沙星氯化钠注射液辰欣药业股份有限公司4CYHS2200616国左氧氟沙星片江苏悦兴医药技术有限公司4CYHS2200505国玻璃酸钠滴眼液呋欧医药科技(湖州)有限公司4CYHS2200366国钆特酸葡胺注射液海南倍特药业有限公司4CYHS2200389国枸橼酸托法替布片江苏康倍得药业股份有限公司4CYHS2200052国氨氯地平阿托伐他汀钙片昆山龙灯瑞迪制药有限公司4CYHS2101616国地舒单抗注射液江苏泰康生物医药有限公司3.3CXSS2101076国托珠单抗注射液百奥泰生物制药股份有限公司3.3CXSS2101048国人凝血酶原复合物国药集团武汉生物制药有限公司3.4CXSL2400019进口申请药品名称企业注册分类受理号BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400020BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400019BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400018BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400017BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400016BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400015BI 456906 注射液Boehringer Ingelheim International GmbH1JXHL2400014PF-07220060Pfizer Inc.1JXHL2400010布地奈德富马酸福莫特罗吸入气雾剂AstraZeneca AB2.4JXHL2400011醋酸兰瑞肽缓释注射液(预充式)IPSEN PHARMA5.1JXHS2300061来曲唑片Eugia Pharma Specialities Limited5.2JYHS2101041国JK07注射液Salubris Biotherapeutics, Inc.1JXSL2400024阿塞西普Vera Therapeutics, Inc.1JXSL2400022Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400008索米妥昔单抗注射液ImmunoGen, Inc.2.2JXSL2400019中药相关申请药品名称企业注册分类受理号痔瘘熏洗颗粒苏中药业集团股份有限公司1.1CXZL2400004香术平胃散江苏中雍红瑞制药有限公司1.1CXZL2400003苓桂术甘汤颗粒华润三九(雅安)药业有限公司3.1CXZS2300016注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-04-02

·药融圈

商业化的残酷性：减重赛道明星公司也曾裁员90%，换CEO…

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。接药融圈上篇《减重赛道巨头林立，丹麦多肽公司Zealand何以成为“关键参与者”？》丹麦多肽公司Zealand Pharma现已是减重赛道的明星公司，但曾屡次在商业化方面碰壁。创新是高风险的，面对现实的残酷性，Zealand的策略是积极寻找合作伙伴，出售产品权益或对外授权，并精简运营，专注于研发。Zealand开发的Zegalogue（Dasiglucagon）是一种新型人胰高血糖素样肽（GLP-1）类似物，2021年3月获得美国FDA批准用于治疗6岁及以上糖尿病患者的严重低血糖，该病是一种急性的、危及生命的疾病，主要由胰岛素治疗相关的血糖水平下降引起。Zegalogue（Dasiglucagon）是首个获批该适应症的GLP-1类似物，可在10分钟之内逆转低血糖状况，Zealand公司还为此开发了自动注射器HypoPal以便患者自我给药，可在室温储存。该产品自2021年6月在美国上市销售，但业绩表现不佳，2022年3月，Zealand宣布在美国的办事处裁员90%，并将其年度运营费用削减至少35%，甚至更换了CEO。这家biotech感受到了商业化的残酷性，希望为自己的产品找到销售合作伙伴。2022年9月，Zealand与诺和诺德就Zegalogue（Dasiglucagon）达成全球许可和开发协议，根据协议，诺和诺德将负责该产品的全球商业化，Zealand将收到2500万丹麦克朗的预付款，并有资格获得4500万丹麦克朗的近期开发、监管和制造里程碑付款。Zealand还有资格获得高达2.2亿丹麦克朗的销售里程碑和分级特许权使用费。同时，Zealand还将继续负责某些计划中的监管、开发和制造活动，以支持该产品在美国以外地区的进一步开发和批准。截图自药融云数据库另一款已上市产品V-Go是一种可穿戴式胰岛素输送设备，适用于需要使用胰岛素的成人患者，以消除每日多次注射的需要。V-Go的商业化也是一波三折，据了解，V-Go来自于早前Zealand以2300万美元收购的Valeritas公司，但该产品同样销售表现不佳，开发出V-GO设备的Valeritas在当时便申请了破产，面对定价压力和竞争激烈的市场条件，V-GO在多个国家的分销协议也在很早就被终止了。最后Zealand也未能成功将该产品商业化，2022年5月，Zealand以1000万美元的价格将V-Go设备卖给了MannKind公司，另外，Zealand还有资格获得基于V-Go销售业绩的里程碑付款。（相关阅读：可穿戴胰岛素梦碎，西兰制药半价抛售V-GO给MannKind）另外，GLP-1RA（胰高糖素样肽-1受体激动剂）利司那肽是Zealand原研的产品。2003年，Zealand将利司那肽在糖尿病领域的开发与商业化许可授予了赛诺菲，包括单药治疗和联合疗法。根据该协议，Zealand有权获得利司那肽（欧洲商品名Lyxumia/美国商品名Adlyxin），以及甘精胰岛素和利司那肽复方制剂（美国商品名Soliqua 100/33/欧洲商品名Suliqua）全球净销售额相关的特许权使用费和商业里程碑付款。不过貌似Zealand对赛诺菲推出的这两款产品的销售表现以及所得款项并不满意，于是决定将该资产变现。2018年9月，新药特许权公司Royalty Pharma宣布以2.05亿美元现金从Zealand手中收购了前述两款产品的未来特许权使用费以及潜在的商业里程款项。此次交易让Zealand获得了财务上的确定性与独立性，后续利司那肽及相关产品也就不在Zealand的管线资产中了。Zealand着眼于全球多肽药物市场，在所有已上市产品的权益都已出售或对外授权之后，Zealand正将精力集中于产品的研发，依托专有的多肽药物开发技术，改善疾病的治疗标准。该公司的研发支出占总运营开支的约80%。近几年，制药领域最为火热的莫过于减重赛道。肥胖既是一场个人的战斗，也是一场公共健康危机。世卫组织估计，全球有超过10亿人患有肥胖症。据摩根士丹利预测，到2030年，全球肥胖市场将达到770亿美元。2023年，《科学》杂志将胰高血糖素样肽-1（GLP-1）受体激动剂的开发以及可缓解肥胖相关健康问题的药物列为年度突破之首。药融云数据（www.pharnexcloud.com）监测显示：目前公司在研的减重领域候选分子有长效GLP-1R/GLP-2R双重激动剂Dapiglutide；Petrelintide（ZP8396），一款潜在best in class的长效胰淀素类似物；Survodutide（BI-456906）；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露（正文图片均来自企业官方，除非另有说明）；https://www.zealandpharma.com/；https://www.fiercepharma.com/marketing/zealand-underwhelmed-by-sanofi-s-soliqua-sales-plans-to-ride-solo-future-launches；https://www.royaltypharma.com/news/royalty-pharma-announces-205-million-acquisition-zealand-pharmas/；等等本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

并购生物类似药

2024-03-29

·梅斯医学

科学减肥策略集锦：每周一次可减重40斤；阻力训练或可改善肥胖、代谢风险和炎症……

肥胖是一种广泛存在的慢性、复发性和进行性疾病，对个人和社会具有重大不良影响。各种健康并发症（包括2型糖尿病、高血压和心血管疾病等）与超重和肥胖相关，这些并发症的患病率随着体重指数（BMI）的增加而增加。世界卫生组织（WHO）将肥胖定义为BMI≥30 kg/m2。而中国肥胖工作组将超重定义为BMI≥24.0 kg/m2，将肥胖定义为28.0 kg/m2。根据中国肥胖工作组的定义，2015年~2019年中国成人超重和肥胖患病率分别估计为34.3%和16.4%，预计到2030年，超重和肥胖的综合患病率将攀升至65%。每周一次可平均减重12.1%！司美格鲁肽也适用于这类人群！除了生活方式干预和减肥手术外，药物治疗在慢性体重管理中也起着重要作用。在STEP（司美格鲁肽用于肥胖患者的治疗效果）临床试验项目中，司美格鲁肽2.4 mg每周一次皮下注射可显著并持续降低超重或肥胖成人的体重。既往STEP 6试验还在东亚人群中评估了该疗法的疗效，显示其相比安慰剂可以显著减轻体重且具有临床意义。STEP 7试验于近期发表于The Lancet Diabetes & Endocrinology，旨在进一步评估司美格鲁肽2.4 mg每周一次在东亚成人体重管理中的有效性和安全性。研究结果显示，在伴或不伴有2型糖尿病的超重或肥胖东亚人群中，司美格鲁肽2.4 mg每周一次皮下注射与安慰剂相比，可显著减轻体重且具有临床意义。从基线至第44周，与安慰剂组相比，司美格鲁肽组的平均体重减少更多：司美格鲁肽2.4 mg组体重的估计平均百分比变化为-12.1%，而安慰剂组为-3.6%（估计治疗差异-8.5%[95% CI -10.2%~-6.8%]；P<0.0001）。在第44周，司美格鲁肽2.4 mg组体重减轻5%或更多的受试者比例高于安慰剂组（203/238[85%] vs. 36/116[31%]）；比值比[OR] 13.1（95% CI 7.4~23.1；P<0.0001）。每周一次可减重达40斤！双重激动剂用于肥胖人群获益显著目前，研究肥胖治疗的其他靶点以改善治疗结局仍然是当务之急。Survodutide是一种胰高血糖素受体/胰高血糖素样肽-1受体（GCGR/GLP-1R）双重激动剂，可每周给药一次。该疗法的临床前研究分析表明，在小鼠模型中，通过同时作用于GCGR和GLP-1R，其治疗可比现有获批的胰高血糖素样肽-1（GLP-1）类药物更大程度地减轻体重。近期，The Lancet Diabetes & Endocrinology发表了关于survodutide治疗肥胖的2期试验结果，研究分析显示，在BMI≥27 kg/m2的非糖尿病成人中，与安慰剂组相比，所有测试剂量的survodutide均能显著减轻受试者的体重（其中0.6 mg组P值为0.026；≥2.4 mg组P值均小于0.0001）。具体而言，按照survodutide治疗计划方案，survodutide 0.6 mg、2.4 mg、3.6 mg、4.8 mg组受试者体重从基线至第46周分别降低6.2%、12.5%、13.2%和14.9%，而安慰剂组降低了2.8%。不过实际治疗期间，接受survodutide 0.6 mg、2.4 mg、3.6 mg、4.8 mg治疗的受试者体重可分别降低6.8%、13.6%、16.7%和18.7%，相当于绝对体重分别减少7.2 kg、13.8 kg、17.1 kg和19.5 kg。图片来源：123RF每周一次总平均减重25.3%！Tirzepatide持续治疗，可保持至少80%的体重减轻Tirzepatide是一种葡萄糖依赖性促胰岛素多肽（GIP）和GLP-1双重受体激动剂，已在包括美国、欧盟和日本在内的许多国家获得批准为每周一次的皮下注射剂以用于治疗2型糖尿病，并在美国和英国获批用于治疗肥胖。在一项针对超重或肥胖但无糖尿病的受试者的安慰剂对照试验中，采用tirzepatide治疗72周后，受试者平均体重减少20.9%。发表于JAMA的一项研究，旨在评估持续使用每周一次、最大耐受剂量（10 mg或15 mg）的tirzepatide配合饮食和身体活动对维持体重减轻的效果。这项研究包括36周的开放标签tirzepatide导入期以及随后的52周双盲安慰剂对照期。研究结果显示，从第36周至第88周，tirzepatide组平均体重变化百分比为-5.5%，安慰剂组为14.0%（差异为-19.4%[95% CI，-21.2%~-17.7%]；P<0.001）。有300例（89.5%）受试者在88周时接受tirzepatide治疗，并在导入期保持了至少80%的体重减轻，而接受安慰剂治疗的受试者为16.6%（P<0.001）。从第0周至第88周，tirzepatide组的总体平均体重减轻25.3%，安慰剂组为9.9%。在超重或肥胖人群中，这两种运动策略均可改善心血管风险心血管疾病（CVD）是导致死亡的主要原因。身体活动（特别是有氧运动）已被证实可以预防CVD。然而，很少有临床试验在超重或肥胖人群中直接评估抗阻训练、抗阻训练联合有氧运动与单独有氧运动相比是否能提供相似或更强的心血管益处。发表于European Heart Journal的一项研究对比进行了评估。研究分析显示，在超重或肥胖成人中，与对照组相比，单独有氧运动或抗阻训练联合有氧运动可改善复合CVD风险（即包括收缩压、低密度脂蛋白胆固醇、空腹血糖和体脂百分比在内的4种已确定的CVD危险因素的标准化复合风险，用z评分表示）。在超重或肥胖成人中，与对照组相比，单独有氧运动（平均差，-0.15[95% CI：-0.27~-0.04]；P=0.01）、阻力训练联合有氧运动（平均差，-0.16[95% CI：-0.27~-0.04]；P=0.009]）的综合z评分在1年时下降，这表明CVD风险状况有所改善，但在单独抗阻训练中则没有。与单独抗阻训练相比，单独有氧运动、阻力训练联合有氧运动的综合z评分降低幅度更大（P均=0.03），单独有氧运动、抗阻训练联合有氧运动之间没有差异（P=0.96）。在这类超重/肥胖人群中，阻力训练或可改善身体肥胖、代谢风险和炎症绝经后的特点是卵巢功能丧失（即雌激素水平低），这与身体脂肪水平增加（特别是腹部脂肪）以及炎症和代谢功能受损有关。公共卫生指南建议将阻力训练作为一种非药物干预措施，以改善身体健康（如心肺健康、肌肉健康和身体成分等），并限制慢性疾病和其他致残状况的发生及发展。发表于Journal of Sport and Health Science的一项研究，旨在评估阻力训练量对绝经后老年女性身体肥胖、代谢风险和炎症的影响。研究结果显示，与对照组相比，两个阻力训练组（包括低负荷阻力训练[LVRT]，~44组/周；和高负荷阻力训练[HVRT]，~77组/周）的身体肥胖、代谢风险和炎症均有所改善；不过，在超重/肥胖绝经后老年女性中，HVRT比LVRT更能改善代谢风险和炎症结局。但需要注意的是，每个人应根据自己的情况来进行合适的运动量。参考资料（可上下滑动查看）[1] Mu Y, et al., (2024). Efficacy and safety of once weekly semaglutide 2.4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol, doi: 10.1016/S2213-8587(23)00388-1.[2] le Roux CW, et al., (2024). Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol, doi: 10.1016/S2213-8587(23)00356-X.[3] Aronne LJ, et al., (2024). Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA, doi: 10.1001/jama.2023.24945.[4] Lee DC, et al., (2024). Aerobic, resistance, or combined exercise training and cardiovascular risk profile in overweight or obese adults: the CardioRACE trial. Eur Heart J, doi: 10.1093/eurheartj/ehad827.[5] Nunes PRP, et al., (2024). Effect of resistance training volume on body adiposity, metabolic risk, and inflammation in postmenopausal and older females: Systematic review and meta-analysis of randomized controlled trials. J Sport Health Sci, doi: 10.1016/j.jshs.2023.09.012.撰文 | 医学新视点编辑 | Swagpp● 震惊！大三甲医生惨痛教训：35岁住院医，工作6年，跟风读研后反而找不到工作了！网友：为读研而读研你太傻！学历贬值你不懂?● 柳叶刀最新：全球生育率持续下降，逼近临界值！25年后，近50%国家的自然增长率为负，中国人口将持续减少● 重磅！！国家卫健委：2024年将推进“先诊疗后付费”等新模式！依靠信用，“花呗”版看病真的来了！意味着什么？版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果

100 项与 Survodutide 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
2型糖尿病	临床3期	中国更多	勃林格殷格翰（中国）投资有限公司更多
超重	临床3期	澳大利亚更多	勃林格殷格翰（中国）投资有限公司更多
肥胖	临床3期	中国更多	勃林格殷格翰（中国）投资有限公司更多
非酒精性脂肪性肝炎	临床2期	中国台湾更多	Boehringer Ingelheim International GmbH 更多
-	临床1期	日本更多	Boehringer Ingelheim GmbH 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04771273 (Corporate Publications) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	295	Survodutide	(顧衊鹹襯獵鑰夢鹹鹹餘) = 鏇積餘鏇顧獵築鏇獵齋觸鏇顧淵膚繭衊鏇醖衊 (窪壓築鑰網壓觸膚獵鬱 ) 达到	积极	2024-02-26
				placebo	(顧衊鹹襯獵鑰夢鹹鹹餘) = 鑰構膚鑰襯繭糧繭願夢觸鏇顧淵膚繭衊鏇醖衊 (窪壓築鑰網壓觸膚獵鬱 ) 达到
NCT04153929 (CTgov)	临床2期	2型糖尿病	413	Placebo (Placebo)	(蓋廠構築觸範淵簾鹹醖) = 簾餘艱範艱築廠鑰製衊夢鹽膚製鹹鹽齋淵襯簾 (遞願夢壓選淵鏇簾簾齋, 築衊鬱廠糧願餘範餘顧 ~ 壓憲觸衊選願鹹蓋鹽鑰) 更多	-	2022-11-29
				BI 456906 (BI 456906 0.3 mg)	(蓋廠構築觸範淵簾鹹醖) = 顧遞築範築網蓋衊網襯夢鹽膚製鹹鹽齋淵襯簾 (遞願夢壓選淵鏇簾簾齋, 鏇鏇鬱積憲憲蓋艱範鏇 ~ 積鑰蓋選構顧餘廠築夢) 更多
NCT04771273 (GlobeNewswire) 人工标引	临床3期	非酒精性脂肪性肝炎	-	survodutide	(膚獵鏇網夢網繭鬱築觸) = 襯鏇網願壓願願艱壓糧蓋艱憲壓願鹹衊鏇製醖 (製鏇鹽鹹糧廠餘積廠蓋 ) 达到	积极	2024-02-26
				Placebo	(膚獵鏇網夢網繭鬱築觸) = 製餘艱積顧醖遞簾製壓蓋艱憲壓願鹹衊鏇製醖 (製鏇鹽鹹糧廠餘積廠蓋 ) 达到
NCT04667377 (CTgov)	临床2期	肥胖	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	(襯鏇淵構鏇願窪糧醖鹽) = 膚顧製蓋淵憲淵餘襯夢獵窪網構膚夢繭艱顧繭 (窪獵鬱簾齋鏇遞選範憲, 鏇鑰鏇製壓窪壓製簾齋 ~ 憲膚淵憲範窪鏇鹽窪鏇) 更多	-	2023-11-02
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	(襯鏇淵構鏇願窪糧醖鹽) = 範觸顧廠範廠範膚鏇淵獵窪網構膚夢繭艱顧繭 (窪獵鬱簾齋鏇遞選範憲, 淵網鑰鬱窪窪網簾網艱 ~ 構簾窪衊範餘選願餘壓) 更多
NCT04667377 (ADA2023) 人工标引	临床2期	超重 \| 肥胖	387	BI 456906 0.6 mg	獵糧襯獵簾範範壓醖鬱(憲顧鏇遞顧繭鑰鹽窪製) = 餘繭糧構蓋製願鹹窪顧蓋範廠襯築廠簾顧獵選 (繭襯淵憲憲糧遞簾積積 ) 更多	积极	2023-06-23
				BI 456906 2.4 mg	獵糧襯獵簾範範壓醖鬱(憲顧鏇遞顧繭鑰鹽窪製) = 襯繭鹽築襯簾積構鑰餘蓋範廠襯築廠簾顧獵選 (繭襯淵憲憲糧遞簾積積 ) 更多