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2026-525472-26-00RecruitingPhase 3

AMBITION 3: A research study investigating how well zenagamtide at higher dose levels lowers blood sugar and body weight compared to semaglutide in people with type 2 diabetes treated with metformin, SGLT2i, or both

Efficacy and safety of zenagamtide s.c. once weekly compared to semaglutide s.c. once weekly at higher dose levels in participants with type 2 diabetes inadequately controlled on metformin, SGLT2i, or both (AMBITION 3)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026

Next steps

Brief summary (registry, in English)

To confirm non-inferiority of [CCI] zenagamtide versus [CCI] semaglutide on change in glycated haemoglobin (HbA1c) in participants with T2D not in adequate glycaemic control on stable dose of metformin, SGLT2i, or both

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
595 (estimated)
First submitted
10 Jul 2026
Start date
27 Oct 2026
Lead sponsor
Novo Nordisk A/S
EU CT number
2026-525472-26-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 595
  • 117 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes whose blood sugar is not well controlled on metformin, an SGLT2 inhibitor, or both.

Age
18 years or older
Sex
All sexes can join (sex assigned at birth, all gender identities).
Disease stage
Type 2 diabetes diagnosed at least 180 days before screening, with blood sugar (HbA1c) not well controlled.
Earlier treatment
Must be on a stable daily dose of metformin, an SGLT2 inhibitor, or both. Must not have had GLP-1 based treatments or amylin analogues, or other diabetes or obesity medicines.
Biomarker or test result
HbA1c level measured by a central laboratory at screening (the exact range is not shown in the record).

Main reasons for not taking part

  • Pregnant, breast-feeding, planning pregnancy, or able to become pregnant and not using adequate contraception
  • Heart attack, stroke, mini-stroke or hospital stay for unstable angina within 60 days before screening
  • Chronic heart failure of NYHA Class IV
  • Planned heart, neck or leg artery revascularisation
  • Diabetic eye disease treated within 180 days before screening, or expected to need treatment within 180 days after

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria [CCI] before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
  • 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 [CCI] 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.

Other illness

  • Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • [CCI].

Who the study is looking for

  • 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) ≥ 180 days before screening.
  • On stable daily dose(s) of metformin, SGLT2 inhibitor, or both (at effective or maximum tolerated dose as judged by the investigator) [CCI] prior to screening.
  • Haemoglobin (HbA1c) [CCI] as determined by central laboratory at screening.
  • [CCI]
  • [CCI]

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (117)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical Center New Polyclinic Gabrovo Ltd.GabrovoBulgariaRecruiting
University Multiprofessional Hospital For Active Treatment Kanev ADRuseBulgariaRecruiting
MBAL Dr. Ivan Seliminski Sliven ADSlivenBulgariaRecruiting
Medical Center Smolyan Klinikal Research Ltd.SmolyanBulgariaRecruiting
Medikal Centre St. Dimitar Ltd.SofiaBulgariaRecruiting
Medical Center Drujba Ltd.SofiaBulgariaRecruiting
Alexandrovska University HospitalSofiaBulgariaRecruiting
Medical Center Orthopedic Institute Kinov Ltd.SofiaBulgariaRecruiting
Medical Center Higiya Ltd.VarnaBulgariaRecruiting
INTENDIA klinika s.r.o.ChrudimCzechiaRecruiting
Aidin VK s.r.o.Hranice I-MestoCzechiaRecruiting
Diabetologicke centrum s.r.o.OlomoucCzechiaRecruiting
EUC Klinika Praha a.s.PragueCzechiaRecruiting
Fledip s.r.o.PragueCzechiaRecruiting
MILAN KVAPIL s.r.o.PragueCzechiaRecruiting
Diabet2 s.r.o.Prague 1CzechiaRecruiting
ENDOTRIAL s.r.oPraha 22CzechiaRecruiting
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad OeynhausenGermanyNot yet recruiting
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbRBerlinGermanyNot yet recruiting
MVZ Hausaerzte Grossenbaum GmbHDuisburgGermanyNot yet recruiting
Zentrum für klinische Forschung, Dr. med. LüdemannFalkenseeGermanyNot yet recruiting
Hausarztzentrum ButendorfGladbeckGermanyNot yet recruiting
Diabeteszentrum Hamburg WestHamburgGermanyNot yet recruiting
Zentrum für Klinische Forschung Köln-DünnwaldKöln-DünnwaldGermanyNot yet recruiting
Gemeinschaftspraxis Dr. Täschner/Dr. BonigutLeipzigGermanyNot yet recruiting
Schwerpunktpraxis für Diabetes und ErnährungsmedizinMünsterGermanyNot yet recruiting
Hausärztliche und Diabetologische Praxis PirnaPirnaGermanyNot yet recruiting
Centrum Fuer Diabetologie Und AllgemeinmedizinPohlheimGermanyNot yet recruiting
Praxis Reinfeld MitteReinfeldGermanyNot yet recruiting
Praxis für Prävention und Therapie, Drs JacobVillingen-SchwenningenGermanyNot yet recruiting
Region MidtjyllandAarhus NDenmarkNot yet recruiting
Sanos A/SGandrupDenmarkNot yet recruiting
Steno Diabetes Center CopenhagenHerlevDenmarkNot yet recruiting
Region SjaellandKoegeDenmarkNot yet recruiting
Region SyddanmarkOdense CDenmarkNot yet recruiting
Centro Periférico de Especialidades Bola AzulAlmeríaSpainRecruiting
Consorci D'atencio Primaria De Salut Barcelona EsquerraBarcelonaSpainRecruiting
Eba Vallcarca SlpBarcelonaSpainRecruiting
Centre d'Atenció Primària Canet de MarBarcelonaSpainRecruiting
Centre d'Atenció Primària SarriàBarcelonaSpainRecruiting
Centro De Salud Cabra Matrona Antonia Mesa FernandezCabraSpainRecruiting
Hospital Nisa Sevilla AljarafeCastilleja De La CuestaSpainRecruiting
Centro de Salud San Juan de la CruzPozuelo de AlarcónSpainRecruiting
CAP Turó de Can MatesSan Cugat del VallésSpainRecruiting
Centro de Salud La CuestaSanta Cruz de TenerifeSpainRecruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainRecruiting
Equip D'assistencia Primaria Vic S.L.P.VicSpainRecruiting
General Hospital of Athens "G. Gennimatas"AthensGreeceRecruiting
Laiko General Hospital of AthensAthensGreeceRecruiting
General Hospital Of Chios SkylitseioChiosGreeceRecruiting
University General Hospital of IoanninaIoanninaGreeceRecruiting
City Hospital Kliniki Monoprosopi I.K.E.KalamataGreeceRecruiting
General University Hospital of LarissaLarissaGreeceRecruiting
Athens Medical Center S.A.Paleo FaliroGreeceRecruiting
Nexthealth S.AThessalonikiGreeceRecruiting
Thermi Clinic S.A.ThessalonikiGreeceRecruiting
General Hospital Of Thessloniki G GennimatasThessalonikiGreeceRecruiting
Geniko Nosokomeio Thessalonikis George PapanikolaouThessalonikiGreeceRecruiting
Poliklinika Solmed d.o.o.Grad ZagrebCroatiaRecruiting
Opća bolnica KarlovacKarlovacCroatiaRecruiting
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske TopliceKrapinske TopliceCroatiaRecruiting
Klinički bolnički centar OsijekOsijekCroatiaRecruiting
Clinical Hospital Centre RijekaRijekaCroatiaRecruiting
General Hospital Dr. Josip BencevicSlavonski BrodCroatiaRecruiting
Poliklinika za oftalmologiju optometriju i neurologiju LuxSolinCroatiaRecruiting
Lausmed KftBajaHungaryRecruiting
DRC Kft.BalatonfüredHungaryRecruiting
Trial Pharma Kft.BékéscsabaHungaryRecruiting
Bekes Varmegyei Koezponti KorhazGyulaHungaryRecruiting
Somogy Vármegyei Kaposi Mór Oktató KórházKaposvárHungaryRecruiting
KomplexLabor Kft.KecskemétHungaryRecruiting
Medifarma-98 Kft.NyíregyházaHungaryRecruiting
University of SzegedSzegedHungaryRecruiting
Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle FontiItalyNot yet recruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico BariBariItalyNot yet recruiting
Azienda Ospedaliero-Universitaria CareggiFlorenceItalyNot yet recruiting
ASST Fatebenefratelli SaccoMilanItalyNot yet recruiting
Azienda Ospedaliero Universitaria ParmaParmaItalyNot yet recruiting
Hospital Santa Maria Della MisericordiaPerugiaItalyNot yet recruiting
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto IRomeItalyNot yet recruiting
Humanitas Mirasole S.p.A.RozzanoItalyNot yet recruiting
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno DiabetologicznyBialystokPolandRecruiting
Optitrial Sp. z o.o.ChojnicePolandRecruiting
Reumed Sp. z o.o.LublinPolandRecruiting
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.Piotrkow TrybunalskiPolandRecruiting
Metabolica Sp. z o.o.TarnówPolandRecruiting
Nbr Polska Tomasz KlodawskiWarsawPolandRecruiting
Clinical Study Center S.C.WrocławPolandRecruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrzePolandRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.AlmadaPortugalNot yet recruiting
CCAB Centro Clinico Academico Braga AssociacaoBragaPortugalNot yet recruiting
Sanfil-Casa De Saude De Santa Filomena S.A.CoimbraPortugalNot yet recruiting
Unidade Local De Saude Da Guarda E.P.E.GuardaPortugalNot yet recruiting
Unidade Local De Saude Do Alto Ave E.P.E.GuimaraesPortugalNot yet recruiting
Hospital de S. Francisco S.A.LeiriaPortugalNot yet recruiting
Hospital Cuf Tejo S.A.LisbonPortugalNot yet recruiting
Unidade Local De Saude De Lisboa Ocidental E.P.E.LisbonPortugalNot yet recruiting
Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima LdaPonte de LimaPortugalNot yet recruiting
Hospital CUF Porto S.A.PortoPortugalNot yet recruiting
Unidade Local De Saude De Matosinhos E.P.E.Senhora Da HoraPortugalNot yet recruiting
Hospor Hospitais Portugueses S.A.SetubalPortugalNot yet recruiting
Casa de Saude Sao Mateus S.A.ViseuPortugalNot yet recruiting
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop LaviniaBaia MareRomaniaRecruiting
Diabet Center S.R.L.BrasovRomaniaRecruiting
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu BucurestiBucharestRomaniaRecruiting
Grandmed S.R.L.OradeaRomaniaRecruiting
Bella Praxis S.R.L.PaşcaniRomaniaRecruiting
Medis Muntenia S.R.L.PitestiRomaniaRecruiting
Diabmed Dr. Popescu Alexandrina S.R.L.PloiestiRomaniaRecruiting
CMI Dr. Busegeanu Mihaela MagdalenaPloieştiRomaniaRecruiting
DIADA, s.r.o.BardejovSlovakiaRecruiting
Human-Care s.r.o.Kosice 1SlovakiaRecruiting
DIAMARTIN, s. r. o.MartinSlovakiaRecruiting
Dentavia s.r.o.PopradSlovakiaRecruiting
Ambulancia diabetologie a poruch latkovej premeny a vyzivy - MUDr. Gabriela ZimovaSpisska Nova VesSlovakiaRecruiting
Sirco 2 s.r.o.SvidnikSlovakiaRecruiting

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