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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 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

450

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Bad Mergentheim, Allemagne, 97980
        • Diabetespraxis Mergentheim
      • Berlin, Allemagne, 13597
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Ludwigshafen, Allemagne, 67059
        • Die Praxis am Ludwigsplatz
      • Mainz, Allemagne, 55116
        • Gesundheitscentrum Mainz (Regner / Schmitt)
      • Münster, Allemagne, 48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Pirna, Allemagne, 01796
        • Hausärztliche und Diabetologische Praxis Pirna
      • Pohlheim, Allemagne, 35415
        • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
  • Brésil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brésil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
      • Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
        • Hospital de Clínicas de Porto Alegre_Porto Alegre
    • São Paulo
      • Campinas, São Paulo, Brésil, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • São Paulo, São Paulo, Brésil, 01228-000
        • CPQuali Pesquisa Clínica Ltda
  • Chine
    • Anhui
      • Hefei, Anhui, Chine, 230012
        • The Second People's Hospital of Hefei-Endocrinology
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Chine, 404199
        • Chongqing University Three Gorges Hospital-Endocrinology
    • Guangdong
      • Huizhou, Guangdong, Chine, 516001
        • Huizhou Central People's Hospital-Endocrinology
      • Shenzhen, Guangdong, Chine, 518035
        • The Second People's Hospital of Shenzhen-Endocrinology
    • Hebei
      • Hengshui, Hebei, Chine, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
      • Shijiazhuang, Hebei, Chine, 050000
        • The Second Hospital of Hebei Medical University-Endocrinology
    • Henan
      • Kaifeng, Henan, Chine, 475000
        • Huaihe Hospital of Henan University-Endocrinology
      • Luoyang, Henan, Chine, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
      • Luoyang, Henan, Chine, 471002
        • Luoyang First People's Hospital-Endocrinology
      • Nanyang, Henan, Chine, 473058
        • The First Affiliated Hospital of Nanyang Medical College-Endocrinology
    • Hunan
      • Changde, Hunan, Chine, 415003
        • The First People's Hospital of Changde City-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, Chine, 213004
        • The First People's Hospital of Changzhou-Endocrinology
      • Nanjing, Jiangsu, Chine, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang, Jiangsu, Chine, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Jilin City, Jilin, Chine, 130041
        • The Second Norman Bethune Hospital of Jilin University-Endocrinology
    • Shandong
      • Jinan, Shandong, Chine, 250013
        • Jinan Central Hospital-General Medicine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 201200
        • Shanghai Pudong New Area People's Hospital-Endocrinology
    • Sichuan
      • Chengdu, Sichuan, Chine, 610071
        • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine, 300070
        • Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
    • Zhejiang
      • Huzhou, Zhejiang, Chine, 313000
        • Huzhou Central Hospital-Endocrinology
  • Corée du Sud
      • Gwangju, Corée du Sud, 61453
        • Chosun University Hospital_Endocrinology
      • Seoul, Corée du Sud, 01830
        • Nowon Eulji Medical Center, Eulji University_Endocrinology
      • Seoul, Corée du Sud, 03181
        • Kangbuk Samsung Hospital_Endocrinology
      • Seoul, Corée du Sud, 03080
        • Seoul National University Hospital_Endocrinology
      • Seoul, Corée du Sud, 03722
        • Severance Hospital, Yonsei University Health System_Endocrinology
      • Seoul, Corée du Sud, 06591
        • The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
      • Seoul, Corée du Sud, 02841
        • Korea University Anam Hospital_Endocrinology
      • Seoul, Corée du Sud, 04763
        • Hanyang University Seoul Hospital_Endocrinology
    • Gangwon-do
      • Wŏnju, Gangwon-do, Corée du Sud, 26426
        • Wonju Severance Christian Hospital_Endocrinology
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Corée du Sud, 14647
        • The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
  • Inde
      • New Delhi, Inde, 110029
        • All India Institute of Medical Sciences (AIIMS)
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Inde, 522001
        • Endolife Specialty Hospitals
    • Chhattisgarh
      • Raipur, Chhattisgarh, Inde, 492099
        • All India Institute of Medical Sciences (AIIMS), Raipur
    • Gujarat
      • Vadodara, Gujarat, Inde, 390001
        • SSG Hospital, Baroda
    • Karnataka
      • Bangalore, Karnataka, Inde, 560092
        • Life Care Hospital and Research Centre
    • Kerala
      • Kozhikode, Kerala, Inde, 673008
        • Government Medical College, Kozhikode
    • Maharashtra
      • Kohlapur, Maharashtra, Inde, 416001
        • Shree Mahalaxmi DIATONE Institute
      • Kolhāpur, Maharashtra, Inde, 416008
        • Excel Endocrine Centre
      • Pune, Maharashtra, Inde, 411002
        • Shree Samarth Hospital
    • Punjab
      • Ludhiana, Punjab, Inde, 141001
        • Dayanand Medical College & Hospital
    • Rajasthan
      • Jaipur, Rajasthan, Inde, 302004
        • SMS Medical College & Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, Inde, 632004
        • Christian Medical College Hospital, Vellore
    • Telangana
      • Hyderabad, Telangana, Inde, 500082
        • NIZAM'S Institute of Medical Sciences
  • Japon
      • Aichi, Japon, 468-0009
        • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
      • Arakawa-ku, Tokyo, Japon, 116-0012
        • Kumanomae Nishimura Naika Clinic_Internal Medicine
      • Chiba-shi, Chiba, Japon, 260-0804
        • Akaicho Clinic_Internal medicine
      • Chikushino-shi, Fukuoka, Japon, 818-0024
        • Ito Naika Clinic_Internal Medicine and Diabetology
      • Gifu, Japon, 501-1194
        • Gifu University Hospital_Diabetes and Endocrinology
      • Ibaraki, Japon, 311-0113
        • Naka Kinen Clinic_Internal medicine
      • Kamakura-shi, Kanagawa, Japon, 247 0072
        • Shonan Kamakura General Hospital_Diabetes and Endocrinology
      • Koriyama-shi, Fukushima, Japon, 963-8851
        • Seino Internal Medicine Clinic_Internal medicine
      • Minato-ku, Tokyo, Japon, 105-8471
        • The Jikei University Hospital_Diabetes, Metabolism, Endocrinology
      • Mito-shi, Ibaraki, Japon, 311-4153
        • Minami Akatsuka Clinic_internal medicine
      • Sendai, Miyagi, Japon, 981-8563
        • Tohoku Rosai Hospital_Diabetes, Endocrinology and Hypertension
      • Tamana-shi, Kumamoto, Japon, 865-0016
        • Higashi Diabetes and Cardiovascular Clinic_Diabetes internal medicine, Cardiology
      • Tokyo, Japon, 103-0027
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japon, 104-0031
        • Fukuwa Clinic_Internal Medicine
      • Tsu-shi, Mie, Japon, 514-1101
        • Mie Chuo Medical Center_Department of Diabetes and Endocrinology
      • Wakayama, Japon, 640-8558
        • Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
    • Japan
      • Oita-shi, Oita,, Japan, Japon, 870 0039
        • Abe Diabetes Clinic_Internal Medicine
  • Pologne
      • Gdansk, Pologne, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gmina Świecie, Pologne, 86-100
        • Nowy Szpital Sp. z o.o.
      • Lublin, Pologne, 20-601
        • Zanamed Medical Clinic Sp. z o.o.
      • Olsztyn, Pologne, 10-117
        • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
      • Olsztyn, Pologne, 10-561
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
      • Oświęcim, Pologne, 32-600
        • Formed 2 Sp. z o.o.
      • Warsaw, Pologne, 02-507
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
      • Zabrze, Pologne, 41-800
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Pologne, 41-500
        • M2M Med. Badania Sp. z o.o.
  • Tchéquie
      • Chrudim III, Tchéquie, 53701
        • INTENDIA klinika s.r.o.
      • Prague, Tchéquie, 150 00
        • EUC Klinika Praha a.s.
      • Prague, Tchéquie, 10400
        • ENDOTRIAL s.r.o.
      • Prague, Tchéquie, 140 00
        • Medicon a.s.
      • Prague, Tchéquie, 149 00
        • Milan Kvapil s.r.o.
      • Prague, Tchéquie, 160 00
        • Fledip s.r.o.
      • Prague, Tchéquie, 190 00
        • DiaIn s.r.o.
      • Praha Klanovice, Tchéquie, 190 14
        • TreDia s.r.o.
  • Turquie (Türkiye)
      • Adana, Turquie (Türkiye), 01060
        • Adana Şehir Eğitim ve Araştırma Hastanesi
      • Adapazarı/Turkiye, Turquie (Türkiye), 54100
        • Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
      • Afyonkarahisar, Turquie (Türkiye), 03200
        • Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
      • Ankara, Turquie (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi
      • Ankara, Turquie (Türkiye), 06500
        • Gazi Üniversitesi Hastanesi- Nefroloji
      • Gaziantep, Turquie (Türkiye), 27070
        • Gaziantep Üniversitesi Hastanesi- Nefroloji
      • Izmir, Turquie (Türkiye), 35100
        • Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
      • Kartal/İstanbul, Turquie (Türkiye), 34865
        • Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
      • Kocaeli, Turquie (Türkiye), 41380
        • Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
      • Yüreğir/ADANA, Turquie (Türkiye), 01250
        • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
    • Melikgazi
      • Kayseri, Melikgazi, Turquie (Türkiye), 38039
        • Erciyes Üniversitesi Hastanesi - Nefroloji
  • États-Unis
    • California
      • La Jolla, California, États-Unis, 92037
        • Scripps Whittier Diabetes Inst
      • Lancaster, California, États-Unis, 93534
        • First Valley Medical Group
      • Lincoln, California, États-Unis, 95648
        • Headlands Research CTR Lincoln
      • San Dimas, California, États-Unis, 91773
        • North America Research Institute
    • Florida
      • Fleming Island, Florida, États-Unis, 32003
        • Northeast Research Institute
      • Hollywood, Florida, États-Unis, 33024
        • Encore Medical Research LLC
      • Miami, Florida, États-Unis, 33155
        • My Preferred Research
      • Mt. Dora, Florida, États-Unis, 32757
        • Adult Medicine of Lake County, Inc
      • Ocoee, Florida, États-Unis, 34761
        • West Orange Endocrinology
      • Orlando, Florida, États-Unis, 32825
        • Florida Inst For Clin Res LLC
      • Tamarac, Florida, États-Unis, 33321
        • Care Access
      • Weston, Florida, États-Unis, 33331
        • Encore Medical Research of Weston
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89148
        • Palm Research Center Inc-Vegas
    • New York
      • Brooklyn, New York, États-Unis, 11220
        • DM Clinical
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27514
        • University of North Carolina Chapel Hill
      • Morehead City, North Carolina, États-Unis, 28557
        • Carteret Medical Group
    • South Carolina
      • Spartanburg, South Carolina, États-Unis, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Bristol, Tennessee, États-Unis, 37620-7352
        • Holston Medical Group Pc
      • Chattanooga, Tennessee, États-Unis, 37404
        • Southeast Renal Research Institute
      • Nashville, Tennessee, États-Unis, 37203
        • Clinical Research Associates
    • Texas
      • Houston, Texas, États-Unis, 77081
        • Southwest Clinical Trials
      • Houston, Texas, États-Unis, 77024
        • Victorium Clinical Research
      • Houston, Texas, États-Unis, 77054
        • Prolato Clinical Research Cntr
      • Katy, Texas, États-Unis, 77450
        • Medical Colleagues-Texas LLP
      • San Antonio, Texas, États-Unis, 78233
        • Northeast Clinical Research of San Antonio
      • Shavano Park, Texas, États-Unis, 78231
        • Consano Clinical Research, LLC

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo

Participants will receive placebo matched to zenagamtide subcutaneously.
Autre: Placebo

Placebo matched to zenagamtide will be administered subcutaneously once weekly.
Expérimental: Zenagamtide

Participants will receive zenagamtide subcutaneously.
Médicament: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in glycated haemoglobin (HbA1c)
Délai: From baseline (week 0) to week 52

Measured in percentage (%)-points
From baseline (week 0) to week 52

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Relative change in body weight
Délai: From baseline (week 0) to week 52

Measured in percentage (%)
From baseline (week 0) to week 52
Change in waist circumference
Délai: From baseline (week 0) to week 52

Measured in centimeter (cm)
From baseline (week 0) to week 52
Change in triglycerides
Délai: 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
Délai: 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)
Délai: From baseline (week 0) to week 52

Measured as ratio to baseline
From baseline (week 0) to week 52
Change in systolic blood pressure
Délai: 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)
Délai: From baseline (week 0) to week 52

Measured in millimole per litre (mmol/L)
From baseline (week 0) to week 52

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novo Nordisk A/S

Les enquêteurs

  • Directeur d'études: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 novembre 2026

Achèvement primaire (Estimé)

31 juillet 2028

Achèvement de l'étude (Estimé)

25 septembre 2028

Dates d'inscription aux études

Première soumission

6 novembre 2026

Première soumission répondant aux critères de contrôle qualité

6 novembre 2026

Première publication (Réel)

12 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NN9489-8034
  • U1111-1335-3313 (Autre identifiant: World Health Organization (WHO))
  • 2026-525471-13 (Autre identifiant: European Medical Agency (EMA))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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