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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 de novembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

450

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo

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

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

Participants will receive zenagamtide subcutaneously.
Medicamento: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in glycated haemoglobin (HbA1c)
Prazo: From baseline (week 0) to week 52

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Relative change in body weight
Prazo: From baseline (week 0) to week 52

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novo Nordisk A/S

Investigadores

  • Diretor de estudo: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de novembro de 2026

Conclusão Primária (Estimado)

31 de julho de 2028

Conclusão do estudo (Estimado)

25 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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