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)
6 de noviembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
450
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Novo Nordisk
- Número de teléfono: (+1) 866-867-7178
- Correo electrónico: clinicaltrials@novonordisk.com
Ubicaciones de estudio
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Bad Mergentheim, Alemania, 97980
- Diabetespraxis Mergentheim
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Berlin, Alemania, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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Ludwigshafen, Alemania, 67059
- Die Praxis am Ludwigsplatz
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Mainz, Alemania, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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Münster, Alemania, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
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Pirna, Alemania, 01796
- Hausärztliche und Diabetologische Praxis Pirna
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Pohlheim, Alemania, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clínicas de Porto Alegre_Porto Alegre
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São Paulo
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Campinas, São Paulo, Brasil, 13060-080
- Instituto de Pesquisa Clínica de Campinas
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São Paulo, São Paulo, Brasil, 01228-000
- CPQuali Pesquisa Clínica Ltda
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Chrudim III, Chequia, 53701
- INTENDIA klinika s.r.o.
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Prague, Chequia, 150 00
- EUC Klinika Praha a.s.
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Prague, Chequia, 10400
- ENDOTRIAL s.r.o.
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Prague, Chequia, 140 00
- Medicon a.s.
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Prague, Chequia, 149 00
- Milan Kvapil s.r.o.
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Prague, Chequia, 160 00
- Fledip s.r.o.
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Prague, Chequia, 190 00
- DiaIn s.r.o.
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Praha Klanovice, Chequia, 190 14
- TreDia s.r.o.
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Gwangju, Corea del Sur, 61453
- Chosun University Hospital_Endocrinology
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Seoul, Corea del Sur, 01830
- Nowon Eulji Medical Center, Eulji University_Endocrinology
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Seoul, Corea del Sur, 03181
- Kangbuk Samsung Hospital_Endocrinology
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital_Endocrinology
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Seoul, Corea del Sur, 03722
- Severance Hospital, Yonsei University Health System_Endocrinology
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Seoul, Corea del Sur, 06591
- The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
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Seoul, Corea del Sur, 02841
- Korea University Anam Hospital_Endocrinology
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Seoul, Corea del Sur, 04763
- Hanyang University Seoul Hospital_Endocrinology
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Gangwon-do
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Wŏnju, Gangwon-do, Corea del Sur, 26426
- Wonju Severance Christian Hospital_Endocrinology
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Corea del Sur, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Whittier Diabetes Inst
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Lancaster, California, Estados Unidos, 93534
- First Valley Medical Group
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Lincoln, California, Estados Unidos, 95648
- Headlands Research CTR Lincoln
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San Dimas, California, Estados Unidos, 91773
- North America Research Institute
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Florida
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Fleming Island, Florida, Estados Unidos, 32003
- Northeast Research Institute
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Hollywood, Florida, Estados Unidos, 33024
- Encore Medical Research LLC
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Miami, Florida, Estados Unidos, 33155
- My Preferred Research
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Mt. Dora, Florida, Estados Unidos, 32757
- Adult Medicine of Lake County, Inc
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Ocoee, Florida, Estados Unidos, 34761
- West Orange Endocrinology
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Orlando, Florida, Estados Unidos, 32825
- Florida Inst For Clin Res LLC
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Tamarac, Florida, Estados Unidos, 33321
- Care Access
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Weston, Florida, Estados Unidos, 33331
- Encore Medical Research of Weston
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89148
- Palm Research Center Inc-Vegas
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New York
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Brooklyn, New York, Estados Unidos, 11220
- DM Clinical
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina Chapel Hill
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Morehead City, North Carolina, Estados Unidos, 28557
- Carteret Medical Group
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Medical Research
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Tennessee
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Bristol, Tennessee, Estados Unidos, 37620-7352
- Holston Medical Group Pc
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Chattanooga, Tennessee, Estados Unidos, 37404
- Southeast Renal Research Institute
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Nashville, Tennessee, Estados Unidos, 37203
- Clinical Research Associates
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Texas
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Houston, Texas, Estados Unidos, 77081
- Southwest Clinical Trials
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Houston, Texas, Estados Unidos, 77024
- Victorium Clinical Research
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Houston, Texas, Estados Unidos, 77054
- Prolato Clinical Research Cntr
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Katy, Texas, Estados Unidos, 77450
- Medical Colleagues-Texas LLP
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San Antonio, Texas, Estados Unidos, 78233
- Northeast Clinical Research of San Antonio
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Shavano Park, Texas, Estados Unidos, 78231
- Consano Clinical Research, LLC
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New Delhi, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
- Endolife Specialty Hospitals
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Chhattisgarh
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Raipur, Chhattisgarh, India, 492099
- All India Institute of Medical Sciences (AIIMS), Raipur
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Gujarat
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Vadodara, Gujarat, India, 390001
- SSG Hospital, Baroda
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Karnataka
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Bangalore, Karnataka, India, 560092
- Life Care Hospital and Research Centre
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Kerala
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Kozhikode, Kerala, India, 673008
- Government Medical College, Kozhikode
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Maharashtra
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Kohlapur, Maharashtra, India, 416001
- Shree Mahalaxmi DIATONE Institute
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Kolhāpur, Maharashtra, India, 416008
- Excel Endocrine Centre
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Pune, Maharashtra, India, 411002
- Shree Samarth Hospital
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Punjab
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Ludhiana, Punjab, India, 141001
- Dayanand Medical College & Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- SMS Medical College & Hospital
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Tamil Nadu
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Vellore, Tamil Nadu, India, 632004
- Christian Medical College Hospital, Vellore
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Telangana
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Hyderabad, Telangana, India, 500082
- NIZAM'S Institute of Medical Sciences
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Aichi, Japón, 468-0009
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
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Arakawa-ku, Tokyo, Japón, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
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Chiba-shi, Chiba, Japón, 260-0804
- Akaicho Clinic_Internal medicine
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Chikushino-shi, Fukuoka, Japón, 818-0024
- Ito Naika Clinic_Internal Medicine and Diabetology
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Gifu, Japón, 501-1194
- Gifu University Hospital_Diabetes and Endocrinology
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Ibaraki, Japón, 311-0113
- Naka Kinen Clinic_Internal medicine
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Kamakura-shi, Kanagawa, Japón, 247 0072
- Shonan Kamakura General Hospital_Diabetes and Endocrinology
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Koriyama-shi, Fukushima, Japón, 963-8851
- Seino Internal Medicine Clinic_Internal medicine
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Minato-ku, Tokyo, Japón, 105-8471
- The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
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Mito-shi, Ibaraki, Japón, 311-4153
- Minami Akatsuka Clinic_internal medicine
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Sendai, Miyagi, Japón, 981-8563
- Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
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Tamana-shi, Kumamoto, Japón, 865-0016
- Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
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Tokyo, Japón, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
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Tokyo, Japón, 104-0031
- Fukuwa Clinic_Internal Medicine
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Tsu-shi, Mie, Japón, 514-1101
- Mie Chuo Medical Center_Department of Diabetes and Endocrinology
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Wakayama, Japón, 640-8558
- Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
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Japan
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Oita-shi, Oita,, Japan, Japón, 870 0039
- Abe Diabetes Clinic_Internal Medicine
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Gdansk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
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Gmina Świecie, Polonia, 86-100
- Nowy Szpital Sp. z o.o.
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Lublin, Polonia, 20-601
- Zanamed Medical Clinic Sp. z o.o.
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Olsztyn, Polonia, 10-117
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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Olsztyn, Polonia, 10-561
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Oświęcim, Polonia, 32-600
- Formed 2 Sp. z o.o.
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Warsaw, Polonia, 02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
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Zabrze, Polonia, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
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Silesian Voivodeship
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Chorzów, Silesian Voivodeship, Polonia, 41-500
- M2M Med. Badania Sp. z o.o.
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Anhui
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Hefei, Anhui, Porcelana, 230012
- The Second People's Hospital of Hefei-Endocrinology
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 404199
- Chongqing University Three Gorges Hospital-Endocrinology
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Guangdong
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Huizhou, Guangdong, Porcelana, 516001
- Huizhou Central People's Hospital-Endocrinology
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Shenzhen, Guangdong, Porcelana, 518035
- The Second People's Hospital of Shenzhen-Endocrinology
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Hebei
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Hengshui, Hebei, Porcelana, 053000
- Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
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Shijiazhuang, Hebei, Porcelana, 050000
- The Second Hospital of Hebei Medical University-Endocrinology
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Henan
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Kaifeng, Henan, Porcelana, 475000
- Huaihe Hospital of Henan University-Endocrinology
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Luoyang, Henan, Porcelana, 471003
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
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Luoyang, Henan, Porcelana, 471002
- Luoyang First People's Hospital-Endocrinology
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Nanyang, Henan, Porcelana, 473058
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
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Hunan
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Changde, Hunan, Porcelana, 415003
- The First People's Hospital of Changde City-Endocrinology
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Jiangsu
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Changzhou, Jiangsu, Porcelana, 213004
- The First People's Hospital of Changzhou-Endocrinology
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Nanjing, Jiangsu, Porcelana, 210011
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Zhenjiang, Jiangsu, Porcelana, 212001
- The Affiliated Hospital of Jiangsu University-Endocrinology
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Jilin
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Jilin City, Jilin, Porcelana, 130041
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
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Shandong
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Jinan, Shandong, Porcelana, 250013
- Jinan Central Hospital-General Medicine
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 201200
- Shanghai Pudong New Area People's Hospital-Endocrinology
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Sichuan
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Chengdu, Sichuan, Porcelana, 610071
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300070
- Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
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Zhejiang
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Huzhou, Zhejiang, Porcelana, 313000
- Huzhou Central Hospital-Endocrinology
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Adana, Turquía (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Adapazarı/Turkiye, Turquía (Türkiye), 54100
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
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Afyonkarahisar, Turquía (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
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Ankara, Turquía (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi
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Ankara, Turquía (Türkiye), 06500
- Gazi Üniversitesi Hastanesi- Nefroloji
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Gaziantep, Turquía (Türkiye), 27070
- Gaziantep Üniversitesi Hastanesi- Nefroloji
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Izmir, Turquía (Türkiye), 35100
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
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Kartal/İstanbul, Turquía (Türkiye), 34865
- Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
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Kocaeli, Turquía (Türkiye), 41380
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
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Yüreğir/ADANA, Turquía (Türkiye), 01250
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
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Melikgazi
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Kayseri, Melikgazi, Turquía (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi - Nefroloji
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Participants will receive placebo matched to zenagamtide subcutaneously. |
Placebo matched to zenagamtide will be administered subcutaneously once weekly. |
|
Experimental: Zenagamtide
Participants will receive zenagamtide subcutaneously. |
Zenagamtide will be administered subcutaneously once weekly. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
Periodo de tiempo: From baseline (week 0) to week 52
|
Measured in percentage (%)-points |
From baseline (week 0) to week 52
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Relative change in body weight
Periodo de tiempo: From baseline (week 0) to week 52
|
Measured in percentage (%) |
From baseline (week 0) to week 52
|
|
Change in waist circumference
Periodo de tiempo: From baseline (week 0) to week 52
|
Measured in centimeter (cm) |
From baseline (week 0) to week 52
|
|
Change in triglycerides
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: From baseline (week 0) to week 52
|
Measured as ratio to baseline |
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
Periodo de tiempo: 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)
Periodo de tiempo: From baseline (week 0) to week 52
|
Measured in millimole per litre (mmol/L) |
From baseline (week 0) to week 52
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de noviembre de 2026
Finalización primaria (Estimado)
31 de julio de 2028
Finalización del estudio (Estimado)
25 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
6 de noviembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de noviembre de 2026
Publicado por primera vez (Actual)
12 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- NN9489-8034
- U1111-1335-3313 (Otro identificador: World Health Organization (WHO))
- 2026-525471-13 (Otro identificador: European Medical Agency (EMA))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .