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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Fountain Valley, California, Forenede Stater, 92708
        • Ark Clinical Research
      • Los Angeles, California, Forenede Stater, 90015
        • Los Angeles Institute for Metabolic Research
      • Spring Valley, California, Forenede Stater, 91978
        • Encompass Clinical Research_Spring Valley
    • Florida
      • Hollywood, Florida, Forenede Stater, 33024
        • Encore Medical Research LLC
      • Miami, Florida, Forenede Stater, 33155
        • My Preferred Research
      • Orlando, Florida, Forenede Stater, 32825
        • Florida Institute for Clinical research
      • Weston, Florida, Forenede Stater, 33331
        • Encore Medical Research of Weston
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham & Women's Hospital
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Accellacare
    • Pennsylvania
      • Washington, Pennsylvania, Forenede Stater, 15301
        • Preferred Primary Care physicians Washington
    • Texas
      • Houston, Texas, Forenede Stater, 77081
        • Southwest Clinical Trials
      • San Antonio, Texas, Forenede 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
  • Rumænien
      • Bucharest, Rumænien, 013764
        • SC Nutrilife SRL
      • Bucharest, Rumænien, 050159
        • Institutul De Pneumoftiziologie Marius Nasta
      • Sibiu, Rumænien, 550371
        • SC Gensan SRL, Policlinica ASTRA
    • Bihor County
      • Oradea, Bihor County, Rumænien, 410147
        • Diabdana S.R.L.
    • Mureș County
      • Reghin, Mureș County, Rumænien, 545300
        • Poli Cardinal Med Srl
      • Târgu Mureş, Mureș County, Rumænien, 540142
        • Sc Mediab Srl
  • Slovakiet
      • Bratislava, Slovakiet, 84108
        • KARDIO-SANUS, spol. s r.o.
      • Bytča, Slovakiet, 014 01
        • Diab - Int, s.r.o.
      • Košice, Slovakiet, 040 01
        • Univerzitna nemocnica L. Pasteura Kosice
      • Nové Zámky, Slovakiet, 940 59
        • FUNKYSTUFF s.r.o
      • Trnava, Slovakiet, 91701
        • JAL s.r.o.
      • Šurany, Slovakiet, 942 01
        • DEImedi, s. r. o.
  • Tyrkiet (Türkiye)
      • Adapazarı/Sakarya, Tyrkiet (Türkiye), 54100
        • Sakarya Eğitim ve Araştırma Hastanesi- Dahiliye
      • Ankara, Tyrkiet (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Dahiliye
      • Bursa, Tyrkiet (Türkiye), 16250
        • Bursa Şehir Hastanesi- Dahiliye
      • Giresun, Tyrkiet (Türkiye), 28100
        • Giresun Eğitim ve Araştırma Hastanesi-Dahiliye
      • Istanbul, Tyrkiet (Türkiye), 34722
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Aile Hekimliği
      • Yuregir/Adana, Tyrkiet (Türkiye), 01060
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo

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

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

Participants will receive zenagamtide subcutaneously.
Medicin: Zenagamtide

Zenagamtide will be administered subcutaneously once weekly.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. november 2026

Primær færdiggørelse (Anslået)

5. juni 2028

Studieafslutning (Anslået)

28. august 2028

Datoer for studieregistrering

Først indsendt

6. november 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9489-8033
  • U1111-1335-3191 (Anden identifikator: World Health Organization (WHO))
  • 2026-525470-18 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner