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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 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

450

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo

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

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

Participants will receive zenagamtide subcutaneously.
Geneesmiddel: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in glycated haemoglobin (HbA1c)
Tijdsspanne: From baseline (week 0) to week 52

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative change in body weight
Tijdsspanne: From baseline (week 0) to week 52

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novo Nordisk A/S

Onderzoekers

  • Studie directeur: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 november 2026

Primaire voltooiing (Geschat)

31 juli 2028

Studie voltooiing (Geschat)

25 september 2028

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren