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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 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

450

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo

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

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

Participants will receive zenagamtide subcutaneously.
Droga: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in glycated haemoglobin (HbA1c)
Lasso di tempo: From baseline (week 0) to week 52

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Relative change in body weight
Lasso di tempo: From baseline (week 0) to week 52

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

Measured in centimeter (cm)
From baseline (week 0) to week 52
Change in triglycerides
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 52

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novo Nordisk A/S

Investigatori

  • Direttore dello studio: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 novembre 2026

Completamento primario (Stimato)

31 luglio 2028

Completamento dello studio (Stimato)

25 settembre 2028

Date di iscrizione allo studio

Primo inviato

6 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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