A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease Treated With Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or Both (AMBITION 2)
2026年11月6日 更新者：Novo Nordisk A/S
Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Placebo in Participants With Type 2 Diabetes and Chronic Kidney Disease Inadequately Controlled on Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or Both
The study is testing zenagamtide in participants with type 2 diabetes and chronic kidney disease. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. Participants will either get zenagamtide or placebo. Which treatment participants get is decided by chance. Zenagamtide is a new medicine that doctors cannot prescribe yet, but it has been tested in humans before.
研究概览
研究类型
介入性
注册 (估计的)
450
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Novo Nordisk
- 电话号码：(+1) 866-867-7178
- 邮箱：clinicaltrials@novonordisk.com
学习地点
-
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Anhui
-
Hefei、Anhui、中国、230012
- The Second People's Hospital of Hefei-Endocrinology
-
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Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、404199
- Chongqing University Three Gorges Hospital-Endocrinology
-
-
Guangdong
-
Huizhou、Guangdong、中国、516001
- Huizhou Central People's Hospital-Endocrinology
-
Shenzhen、Guangdong、中国、518035
- The Second People's Hospital of Shenzhen-Endocrinology
-
-
Hebei
-
Hengshui、Hebei、中国、053000
- Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
-
Shijiazhuang、Hebei、中国、050000
- The Second Hospital of Hebei Medical University-Endocrinology
-
-
Henan
-
Kaifeng、Henan、中国、475000
- Huaihe Hospital of Henan University-Endocrinology
-
Luoyang、Henan、中国、471003
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
-
Luoyang、Henan、中国、471002
- Luoyang First People's Hospital-Endocrinology
-
Nanyang、Henan、中国、473058
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
-
-
Hunan
-
Changde、Hunan、中国、415003
- The First People's Hospital of Changde City-Endocrinology
-
-
Jiangsu
-
Changzhou、Jiangsu、中国、213004
- The First People's Hospital of Changzhou-Endocrinology
-
Nanjing、Jiangsu、中国、210011
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
-
Zhenjiang、Jiangsu、中国、212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
-
-
Jilin
-
Jilin City、Jilin、中国、130041
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
-
-
Shandong
-
Jinan、Shandong、中国、250013
- Jinan Central Hospital-General Medicine
-
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Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、201200
- Shanghai Pudong New Area People's Hospital-Endocrinology
-
-
Sichuan
-
Chengdu、Sichuan、中国、610071
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
-
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Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300070
- Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
-
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Zhejiang
-
Huzhou、Zhejiang、中国、313000
- Huzhou Central Hospital-Endocrinology
-
-
-
-
-
New Delhi、印度、110029
- All India Institute of Medical Sciences (AIIMS)
-
-
Andhra Pradesh
-
Guntur、Andhra Pradesh、印度、522001
- Endolife Specialty Hospitals
-
-
Chhattisgarh
-
Raipur、Chhattisgarh、印度、492099
- All India Institute of Medical Sciences (AIIMS), Raipur
-
-
Gujarat
-
Vadodara、Gujarat、印度、390001
- SSG Hospital, Baroda
-
-
Karnataka
-
Bangalore、Karnataka、印度、560092
- Life Care Hospital and Research Centre
-
-
Kerala
-
Kozhikode、Kerala、印度、673008
- Government Medical College, Kozhikode
-
-
Maharashtra
-
Kohlapur、Maharashtra、印度、416001
- Shree Mahalaxmi DIATONE Institute
-
Kolhāpur、Maharashtra、印度、416008
- Excel Endocrine Centre
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Pune、Maharashtra、印度、411002
- Shree Samarth Hospital
-
-
Punjab
-
Ludhiana、Punjab、印度、141001
- Dayanand Medical College & Hospital
-
-
Rajasthan
-
Jaipur、Rajasthan、印度、302004
- SMS Medical College & Hospital
-
-
Tamil Nadu
-
Vellore、Tamil Nadu、印度、632004
- Christian Medical College Hospital, Vellore
-
-
Telangana
-
Hyderabad、Telangana、印度、500082
- NIZAM'S Institute of Medical Sciences
-
-
-
-
-
Adana、土耳其（türkiye）、01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Adapazarı/Turkiye、土耳其（türkiye）、54100
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
-
Afyonkarahisar、土耳其（türkiye）、03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
-
Ankara、土耳其（türkiye）、06800
- Ankara Bilkent Şehir Hastanesi
-
Ankara、土耳其（türkiye）、06500
- Gazi Üniversitesi Hastanesi- Nefroloji
-
Gaziantep、土耳其（türkiye）、27070
- Gaziantep Üniversitesi Hastanesi- Nefroloji
-
Izmir、土耳其（türkiye）、35100
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
-
Kartal/İstanbul、土耳其（türkiye）、34865
- Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
-
Kocaeli、土耳其（türkiye）、41380
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
-
Yüreğir/ADANA、土耳其（türkiye）、01250
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
-
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Melikgazi
-
Kayseri、Melikgazi、土耳其（türkiye）、38039
- Erciyes Üniversitesi Hastanesi - Nefroloji
-
-
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、巴西、90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
-
Porto Alegre、Rio Grande do Sul、巴西、90035-903
- Hospital de Clínicas de Porto Alegre_Porto Alegre
-
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São Paulo
-
Campinas、São Paulo、巴西、13060-080
- Instituto de Pesquisa Clínica de Campinas
-
São Paulo、São Paulo、巴西、01228-000
- CPQuali Pesquisa Clínica Ltda
-
-
-
-
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Bad Mergentheim、德国、97980
- Diabetespraxis Mergentheim
-
Berlin、德国、13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Ludwigshafen、德国、67059
- Die Praxis am Ludwigsplatz
-
Mainz、德国、55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
-
Münster、德国、48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
-
Pirna、德国、01796
- Hausärztliche und Diabetologische Praxis Pirna
-
Pohlheim、德国、35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
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-
-
-
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Chrudim III、捷克语、53701
- INTENDIA klinika s.r.o.
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Prague、捷克语、150 00
- EUC Klinika Praha a.s.
-
Prague、捷克语、10400
- ENDOTRIAL s.r.o.
-
Prague、捷克语、140 00
- Medicon a.s.
-
Prague、捷克语、149 00
- Milan Kvapil s.r.o.
-
Prague、捷克语、160 00
- Fledip s.r.o.
-
Prague、捷克语、190 00
- DiaIn s.r.o.
-
Praha Klanovice、捷克语、190 14
- TreDia s.r.o.
-
-
-
-
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Aichi、日本、468-0009
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
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Arakawa-ku, Tokyo、日本、116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
-
Chiba-shi, Chiba、日本、260-0804
- Akaicho Clinic_Internal medicine
-
Chikushino-shi, Fukuoka、日本、818-0024
- Ito Naika Clinic_Internal Medicine and Diabetology
-
Gifu、日本、501-1194
- Gifu University Hospital_Diabetes and Endocrinology
-
Ibaraki、日本、311-0113
- Naka Kinen Clinic_Internal medicine
-
Kamakura-shi, Kanagawa、日本、247 0072
- Shonan Kamakura General Hospital_Diabetes and Endocrinology
-
Koriyama-shi, Fukushima、日本、963-8851
- Seino Internal Medicine Clinic_Internal medicine
-
Minato-ku, Tokyo、日本、105-8471
- The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
-
Mito-shi, Ibaraki、日本、311-4153
- Minami Akatsuka Clinic_internal medicine
-
Sendai, Miyagi、日本、981-8563
- Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
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Tamana-shi, Kumamoto、日本、865-0016
- Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
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Tokyo、日本、103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
-
Tokyo、日本、104-0031
- Fukuwa Clinic_Internal Medicine
-
Tsu-shi, Mie、日本、514-1101
- Mie Chuo Medical Center_Department of Diabetes and Endocrinology
-
Wakayama、日本、640-8558
- Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
-
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Japan
-
Oita-shi, Oita,、Japan、日本、870 0039
- Abe Diabetes Clinic_Internal Medicine
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-
-
-
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Gdansk、波兰、80-214
- Uniwersyteckie Centrum Kliniczne
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Gmina Świecie、波兰、86-100
- Nowy Szpital Sp. z o.o.
-
Lublin、波兰、20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Olsztyn、波兰、10-117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
-
Olsztyn、波兰、10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Oświęcim、波兰、32-600
- Formed 2 Sp. z o.o.
-
Warsaw、波兰、02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
-
Zabrze、波兰、41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
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Silesian Voivodeship
-
Chorzów、Silesian Voivodeship、波兰、41-500
- M2M Med. Badania Sp. z o.o.
-
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-
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California
-
La Jolla、California、美国、92037
- Scripps Whittier Diabetes Inst
-
Lancaster、California、美国、93534
- First Valley Medical Group
-
Lincoln、California、美国、95648
- Headlands Research CTR Lincoln
-
San Dimas、California、美国、91773
- North America Research Institute
-
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Florida
-
Fleming Island、Florida、美国、32003
- Northeast Research Institute
-
Hollywood、Florida、美国、33024
- Encore Medical Research LLC
-
Miami、Florida、美国、33155
- My Preferred Research
-
Mt. Dora、Florida、美国、32757
- Adult Medicine of Lake County, Inc
-
Ocoee、Florida、美国、34761
- West Orange Endocrinology
-
Orlando、Florida、美国、32825
- Florida Inst For Clin Res LLC
-
Tamarac、Florida、美国、33321
- Care Access
-
Weston、Florida、美国、33331
- Encore Medical Research of Weston
-
-
Nevada
-
Las Vegas、Nevada、美国、89148
- Palm Research Center Inc-Vegas
-
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New York
-
Brooklyn、New York、美国、11220
- DM Clinical
-
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North Carolina
-
Chapel Hill、North Carolina、美国、27514
- University of North Carolina Chapel Hill
-
Morehead City、North Carolina、美国、28557
- Carteret Medical Group
-
-
South Carolina
-
Spartanburg、South Carolina、美国、29303
- Spartanburg Medical Research
-
-
Tennessee
-
Bristol、Tennessee、美国、37620-7352
- Holston Medical Group Pc
-
Chattanooga、Tennessee、美国、37404
- Southeast Renal Research Institute
-
Nashville、Tennessee、美国、37203
- Clinical Research Associates
-
-
Texas
-
Houston、Texas、美国、77081
- Southwest Clinical Trials
-
Houston、Texas、美国、77024
- Victorium Clinical Research
-
Houston、Texas、美国、77054
- Prolato Clinical Research Cntr
-
Katy、Texas、美国、77450
- Medical Colleagues-Texas LLP
-
San Antonio、Texas、美国、78233
- Northeast Clinical Research of San Antonio
-
Shavano Park、Texas、美国、78231
- Consano Clinical Research, LLC
-
-
-
-
-
Gwangju、韩国、61453
- Chosun University Hospital_Endocrinology
-
Seoul、韩国、01830
- Nowon Eulji Medical Center, Eulji University_Endocrinology
-
Seoul、韩国、03181
- Kangbuk Samsung Hospital_Endocrinology
-
Seoul、韩国、03080
- Seoul National University Hospital_Endocrinology
-
Seoul、韩国、03722
- Severance Hospital, Yonsei University Health System_Endocrinology
-
Seoul、韩国、06591
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
-
Seoul、韩国、02841
- Korea University Anam Hospital_Endocrinology
-
Seoul、韩国、04763
- Hanyang University Seoul Hospital_Endocrinology
-
-
Gangwon-do
-
Wŏnju、Gangwon-do、韩国、26426
- Wonju Severance Christian Hospital_Endocrinology
-
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Gyeonggi-do
-
Bucheon-si、Gyeonggi-do、韩国、14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female (sex assigned at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes (T2D) above or equal to 180 days before screening.
- On stable once-daily dose of basal insulin (minimum of 0.25 Unit per kilogram per day or 20 Unit per day) at the investigator's discretion alone or in combination with metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i) or both (at stable effective or maximum tolerated dose as judged by the investigator) prior to screening. Basal insulin dose is considered stable when all doses during this period are within the range defined by plus minus 20%.
- History of chronic kidney disease based on medical records or as judged by the investigator.
- Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes or short-term insulin treatment for a maximum of 14 consecutive days is allowed.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-vascular endothelial growth factor within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Lupus nephritis or antineutrophil cytoplasmic (ANCA)-associated vasculitis.
- Any primary or secondary kidney disease requiring immunosuppressive therapy prior to screening.
- Chronic or intermittent haemodialysis or peritoneal dialysis before screening.
- Combination use of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) within 30 days prior to screening.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Participants will receive placebo matched to zenagamtide subcutaneously. |
Placebo matched to zenagamtide will be administered subcutaneously once weekly. |
|
实验性的：Zenagamtide
Participants will receive zenagamtide subcutaneously. |
Zenagamtide will be administered subcutaneously once weekly. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
大体时间：From baseline (week 0) to week 52
|
Measured in percentage (%)-points |
From baseline (week 0) to week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relative change in body weight
大体时间：From baseline (week 0) to week 52
|
Measured in percentage (%) |
From baseline (week 0) to week 52
|
|
Change in waist circumference
大体时间：From baseline (week 0) to week 52
|
Measured in centimeter (cm) |
From baseline (week 0) to week 52
|
|
Change in triglycerides
大体时间：From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in Non-high-density lipoprotein (Non-HDL) cholesterol
大体时间：From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
大体时间：From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
大体时间：From baseline (week 0) to week 52
|
Measured in millimeters of mercury (mmHg) |
From baseline (week 0) to week 52
|
|
Change in 7-point self-measured plasma glucose (SMPG) profiles: Mean postprandial increment (over all meals)
大体时间：From baseline (week 0) to week 52
|
Measured in millimole per litre (mmol/L) |
From baseline (week 0) to week 52
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月10日
初级完成 (估计的)
2028年7月31日
研究完成 (估计的)
2028年9月25日
研究注册日期
首次提交
2026年11月6日
首先提交符合 QC 标准的
2026年11月6日
首次发布 (实际的)
2026年11月12日
研究记录更新
最后更新发布 (实际的)
2026年11月12日
上次提交的符合 QC 标准的更新
2026年11月6日
最后验证
2026年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NN9489-8034
- U1111-1335-3313 (其他标识符：World Health Organization (WHO))
- 2026-525471-13 (其他标识符：European Medical Agency (EMA))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.