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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 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

450

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • 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
  • Forente stater
    • California
      • La Jolla, California, Forente stater, 92037
        • Scripps Whittier Diabetes Inst
      • Lancaster, California, Forente stater, 93534
        • First Valley Medical Group
      • Lincoln, California, Forente stater, 95648
        • Headlands Research CTR Lincoln
      • San Dimas, California, Forente stater, 91773
        • North America Research Institute
    • Florida
      • Fleming Island, Florida, Forente stater, 32003
        • Northeast Research Institute
      • Hollywood, Florida, Forente stater, 33024
        • Encore Medical Research LLC
      • Miami, Florida, Forente stater, 33155
        • My Preferred Research
      • Mt. Dora, Florida, Forente stater, 32757
        • Adult Medicine of Lake County, Inc
      • Ocoee, Florida, Forente stater, 34761
        • West Orange Endocrinology
      • Orlando, Florida, Forente stater, 32825
        • Florida Inst For Clin Res LLC
      • Tamarac, Florida, Forente stater, 33321
        • Care Access
      • Weston, Florida, Forente stater, 33331
        • Encore Medical Research of Weston
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89148
        • Palm Research Center Inc-Vegas
    • New York
      • Brooklyn, New York, Forente stater, 11220
        • DM Clinical
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27514
        • University of North Carolina Chapel Hill
      • Morehead City, North Carolina, Forente stater, 28557
        • Carteret Medical Group
    • South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • Spartanburg Medical Research
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620-7352
        • Holston Medical Group Pc
      • Chattanooga, Tennessee, Forente stater, 37404
        • Southeast Renal Research Institute
      • Nashville, Tennessee, Forente stater, 37203
        • Clinical Research Associates
    • Texas
      • Houston, Texas, Forente stater, 77081
        • Southwest Clinical Trials
      • Houston, Texas, Forente stater, 77024
        • Victorium Clinical Research
      • Houston, Texas, Forente stater, 77054
        • Prolato Clinical Research Cntr
      • Katy, Texas, Forente stater, 77450
        • Medical Colleagues-Texas LLP
      • San Antonio, Texas, Forente stater, 78233
        • Northeast Clinical Research of San Antonio
      • Shavano Park, Texas, Forente stater, 78231
        • Consano Clinical Research, LLC
  • 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
  • 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
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230012
        • The Second People's Hospital of Hefei-Endocrinology
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 404199
        • Chongqing University Three Gorges Hospital-Endocrinology
    • Guangdong
      • Huizhou, Guangdong, Kina, 516001
        • Huizhou Central People's Hospital-Endocrinology
      • Shenzhen, Guangdong, Kina, 518035
        • The Second People's Hospital of Shenzhen-Endocrinology
    • Hebei
      • Hengshui, Hebei, Kina, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
      • Shijiazhuang, Hebei, Kina, 050000
        • The Second Hospital of Hebei Medical University-Endocrinology
    • Henan
      • Kaifeng, Henan, Kina, 475000
        • Huaihe Hospital of Henan University-Endocrinology
      • Luoyang, Henan, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
      • Luoyang, Henan, Kina, 471002
        • Luoyang First People's Hospital-Endocrinology
      • Nanyang, Henan, Kina, 473058
        • The First Affiliated Hospital of Nanyang Medical College-Endocrinology
    • Hunan
      • Changde, Hunan, Kina, 415003
        • The First People's Hospital of Changde City-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213004
        • The First People's Hospital of Changzhou-Endocrinology
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang, Jiangsu, Kina, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Jilin City, Jilin, Kina, 130041
        • The Second Norman Bethune Hospital of Jilin University-Endocrinology
    • Shandong
      • Jinan, Shandong, Kina, 250013
        • Jinan Central Hospital-General Medicine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201200
        • Shanghai Pudong New Area People's Hospital-Endocrinology
    • Sichuan
      • Chengdu, Sichuan, Kina, 610071
        • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300070
        • Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
    • Zhejiang
      • Huzhou, Zhejiang, Kina, 313000
        • Huzhou Central Hospital-Endocrinology
  • 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.
  • Sør -Korea
      • Gwangju, Sør -Korea, 61453
        • Chosun University Hospital_Endocrinology
      • Seoul, Sør -Korea, 01830
        • Nowon Eulji Medical Center, Eulji University_Endocrinology
      • Seoul, Sør -Korea, 03181
        • Kangbuk Samsung Hospital_Endocrinology
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital_Endocrinology
      • Seoul, Sør -Korea, 03722
        • Severance Hospital, Yonsei University Health System_Endocrinology
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
      • Seoul, Sør -Korea, 02841
        • Korea University Anam Hospital_Endocrinology
      • Seoul, Sør -Korea, 04763
        • Hanyang University Seoul Hospital_Endocrinology
    • Gangwon-do
      • Wŏnju, Gangwon-do, Sør -Korea, 26426
        • Wonju Severance Christian Hospital_Endocrinology
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Sør -Korea, 14647
        • The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
  • Tsjekkia
      • Chrudim III, Tsjekkia, 53701
        • INTENDIA klinika s.r.o.
      • Prague, Tsjekkia, 150 00
        • EUC Klinika Praha a.s.
      • Prague, Tsjekkia, 10400
        • ENDOTRIAL s.r.o.
      • Prague, Tsjekkia, 140 00
        • Medicon a.s.
      • Prague, Tsjekkia, 149 00
        • Milan Kvapil s.r.o.
      • Prague, Tsjekkia, 160 00
        • Fledip s.r.o.
      • Prague, Tsjekkia, 190 00
        • DiaIn s.r.o.
      • Praha Klanovice, Tsjekkia, 190 14
        • TreDia s.r.o.
  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye), 01060
        • Adana Şehir Eğitim ve Araştırma Hastanesi
      • Adapazarı/Turkiye, Tyrkia (Türkiye), 54100
        • Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
      • Afyonkarahisar, Tyrkia (Türkiye), 03200
        • Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
      • Ankara, Tyrkia (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi
      • Ankara, Tyrkia (Türkiye), 06500
        • Gazi Üniversitesi Hastanesi- Nefroloji
      • Gaziantep, Tyrkia (Türkiye), 27070
        • Gaziantep Üniversitesi Hastanesi- Nefroloji
      • Izmir, Tyrkia (Türkiye), 35100
        • Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
      • Kartal/İstanbul, Tyrkia (Türkiye), 34865
        • Sağlık Bilimleri Üniversitesi Kartal Dr Lütfi Kırdar Şehir Hastanesi - Nefroloji
      • Kocaeli, Tyrkia (Türkiye), 41380
        • Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
      • Yüreğir/ADANA, Tyrkia (Türkiye), 01250
        • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
    • Melikgazi
      • Kayseri, Melikgazi, Tyrkia (Türkiye), 38039
        • Erciyes Üniversitesi Hastanesi - Nefroloji
  • Tyskland
      • Bad Mergentheim, Tyskland, 97980
        • Diabetespraxis Mergentheim
      • Berlin, Tyskland, 13597
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Ludwigshafen, Tyskland, 67059
        • Die Praxis am Ludwigsplatz
      • Mainz, Tyskland, 55116
        • Gesundheitscentrum Mainz (Regner / Schmitt)
      • Münster, Tyskland, 48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Pirna, Tyskland, 01796
        • Hausärztliche und Diabetologische Praxis Pirna
      • Pohlheim, Tyskland, 35415
        • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo

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

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

Participants will receive zenagamtide subcutaneously.
Legemiddel: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in glycated haemoglobin (HbA1c)
Tidsramme: From baseline (week 0) to week 52

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative change in body weight
Tidsramme: From baseline (week 0) to week 52

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

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

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. november 2026

Primær fullføring (Antatt)

31. juli 2028

Studiet fullført (Antatt)

25. september 2028

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere