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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 Treated With Diet and Exercise (AMBITION 1)

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 Inadequately Controlled on Diet and Exercise

This study is being done to look at how well zenagamtide lowers blood sugar levels and body weight in people with type 2 diabetes when compared to placebo. Participants will either get zenagamtide, the treatment being tested or placebo, a treatment that has no active medicine in it. 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)

200

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

  • Forente stater
    • California
      • Fountain Valley, California, Forente stater, 92708
        • Ark Clinical Research
      • Los Angeles, California, Forente stater, 90015
        • Los Angeles Institute for Metabolic Research
      • Spring Valley, California, Forente stater, 91978
        • Encompass Clinical Research_Spring Valley
    • Florida
      • Hollywood, Florida, Forente stater, 33024
        • Encore Medical Research LLC
      • Miami, Florida, Forente stater, 33155
        • My Preferred Research
      • Orlando, Florida, Forente stater, 32825
        • Florida Institute for Clinical research
      • Weston, Florida, Forente stater, 33331
        • Encore Medical Research of Weston
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham & Women's Hospital
    • North Carolina
      • Wilmington, North Carolina, Forente stater, 28401
        • Accellacare
    • Pennsylvania
      • Washington, Pennsylvania, Forente stater, 15301
        • Preferred Primary Care physicians Washington
    • Texas
      • Houston, Texas, Forente stater, 77081
        • Southwest Clinical Trials
      • San Antonio, Texas, Forente stater, 78222
        • Pinnacle Clinical Research
  • Japan
      • Chiba-shi, Chiba, Japan, 260-0804
        • Akaicho Clinic_Internal medicine
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 104-0031
        • Fukuwa Clinic_Internal Medicine
      • Tokyo, Japan, 160-0008
        • ToCROM Clinic_Internal Medicine
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • OCROM Clinic_Internal medicine
  • Kina
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 404199
        • Chongqing University Three Gorges Hospital-Endocrinology
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang, Jiangsu, Kina, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Shandong
      • Jinan, Shandong, Kina, 250013
        • Jinan Central Hospital-General Medicine
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300134
        • Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Metabolism
  • Polen
      • Katowice, Polen, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Malbork, Polen, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
      • Oświęcim, Polen, 32-600
        • Formed 2 Sp. z o.o.
      • Staszów, Polen, 28-200
        • Velocity Nova Sp. z o.o.
      • Warsaw, Polen, 00-710
        • NBR Polska Tomasz Klodawski
      • Świnoujście, Polen, 72-600
        • Balticmed Świnoujście Sp. z o. o.
    • Masovian Voivodeship
      • Płock, Masovian Voivodeship, Polen, 09-407
        • Cbk Med Clinic Sp. z o.o.
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Solace Clinical Research
  • Romania
      • Bucharest, Romania, 013764
        • SC Nutrilife SRL
      • Bucharest, Romania, 050159
        • Institutul De Pneumoftiziologie Marius Nasta
      • Sibiu, Romania, 550371
        • SC Gensan SRL, Policlinica ASTRA
    • Bihor County
      • Oradea, Bihor County, Romania, 410147
        • Diabdana S.R.L.
    • Mureș County
      • Reghin, Mureș County, Romania, 545300
        • Poli Cardinal Med Srl
      • Târgu Mureş, Mureș County, Romania, 540142
        • Sc Mediab Srl
  • Slovakia
      • Bratislava, Slovakia, 84108
        • KARDIO-SANUS, spol. s r.o.
      • Bytča, Slovakia, 014 01
        • Diab - Int, s.r.o.
      • Košice, Slovakia, 040 01
        • Univerzitna nemocnica L. Pasteura Kosice
      • Nové Zámky, Slovakia, 940 59
        • FUNKYSTUFF s.r.o
      • Trnava, Slovakia, 91701
        • JAL s.r.o.
      • Šurany, Slovakia, 942 01
        • DEImedi, s. r. o.
  • Tyrkia (Türkiye)
      • Adapazarı/Sakarya, Tyrkia (Türkiye), 54100
        • Sakarya Eğitim ve Araştırma Hastanesi- Dahiliye
      • Ankara, Tyrkia (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Dahiliye
      • Bursa, Tyrkia (Türkiye), 16250
        • Bursa Şehir Hastanesi- Dahiliye
      • Giresun, Tyrkia (Türkiye), 28100
        • Giresun Eğitim ve Araştırma Hastanesi-Dahiliye
      • Istanbul, Tyrkia (Türkiye), 34722
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Aile Hekimliği
      • Yuregir/Adana, Tyrkia (Türkiye), 01060
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

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, inclusive of all gender identities).
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 30 days before screening.
  • Treatment naïve to any glucose-lowering medication(s).

Exclusion criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Current treatment or history of treatment with any medication for the indication of diabetes, or 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 for any indication. However, previous insulin treatment during Gestational Diabetes Mellitus is allowed.
  • Treatment with any medication for the indication of obesity before screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) 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 non-dilated 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 (NYHA) Class IV at screening.
  • Planned coronary, carotid or peripheral artery revascularisation.

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.
Legemiddel: 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 44

Measured as percentage (%) - points.
From baseline (week 0) to week 44

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative change in body weight
Tidsramme: From baseline (week 0) to week 44

Measured as %.
From baseline (week 0) to week 44
Change in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)
Tidsramme: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in triglycerides
Tidsramme: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in non-high-density lipoprotein (non-HDL) cholesterol
Tidsramme: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in high sensitivity C-reactive protein (hsCRP)
Tidsramme: From baseline (week 0) to week 44

Measured as ratio to baseline.
From baseline (week 0) to week 44
Change in 7-point self-measured plasma glucose (SMPG) profiles: Mean postprandial increment (over all meals)
Tidsramme: From baseline (week 0) to week 44

Measured as millimoles per liter (mmol/L).
From baseline (week 0) to week 44
Change in systolic blood pressure
Tidsramme: From baseline (week 0) to week 44

Measured as millimeters of mercury (mmHg).
From baseline (week 0) to week 44

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)

5. juni 2028

Studiet fullført (Antatt)

28. august 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

  • NN9489-8033
  • U1111-1335-3191 (Annen identifikator: World Health Organization (WHO))
  • 2026-525470-18 (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