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
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
- Diseases
- Type 2 diabetes
- 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
Sites (117)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center New Polyclinic Gabrovo Ltd. | Gabrovo | Bulgaria | Recruiting |
| University Multiprofessional Hospital For Active Treatment Kanev AD | Ruse | Bulgaria | Recruiting |
| MBAL Dr. Ivan Seliminski Sliven AD | Sliven | Bulgaria | Recruiting |
| Medical Center Smolyan Klinikal Research Ltd. | Smolyan | Bulgaria | Recruiting |
| Medikal Centre St. Dimitar Ltd. | Sofia | Bulgaria | Recruiting |
| Medical Center Drujba Ltd. | Sofia | Bulgaria | Recruiting |
| Alexandrovska University Hospital | Sofia | Bulgaria | Recruiting |
| Medical Center Orthopedic Institute Kinov Ltd. | Sofia | Bulgaria | Recruiting |
| Medical Center Higiya Ltd. | Varna | Bulgaria | Recruiting |
| INTENDIA klinika s.r.o. | Chrudim | Czechia | Recruiting |
| Aidin VK s.r.o. | Hranice I-Mesto | Czechia | Recruiting |
| Diabetologicke centrum s.r.o. | Olomouc | Czechia | Recruiting |
| EUC Klinika Praha a.s. | Prague | Czechia | Recruiting |
| Fledip s.r.o. | Prague | Czechia | Recruiting |
| MILAN KVAPIL s.r.o. | Prague | Czechia | Recruiting |
| Diabet2 s.r.o. | Prague 1 | Czechia | Recruiting |
| ENDOTRIAL s.r.o | Praha 22 | Czechia | Recruiting |
| Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum | Bad Oeynhausen | Germany | Not yet recruiting |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR | Berlin | Germany | Not yet recruiting |
| MVZ Hausaerzte Grossenbaum GmbH | Duisburg | Germany | Not yet recruiting |
| Zentrum für klinische Forschung, Dr. med. Lüdemann | Falkensee | Germany | Not yet recruiting |
| Hausarztzentrum Butendorf | Gladbeck | Germany | Not yet recruiting |
| Diabeteszentrum Hamburg West | Hamburg | Germany | Not yet recruiting |
| Zentrum für Klinische Forschung Köln-Dünnwald | Köln-Dünnwald | Germany | Not yet recruiting |
| Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut | Leipzig | Germany | Not yet recruiting |
| Schwerpunktpraxis für Diabetes und Ernährungsmedizin | Münster | Germany | Not yet recruiting |
| Hausärztliche und Diabetologische Praxis Pirna | Pirna | Germany | Not yet recruiting |
| Centrum Fuer Diabetologie Und Allgemeinmedizin | Pohlheim | Germany | Not yet recruiting |
| Praxis Reinfeld Mitte | Reinfeld | Germany | Not yet recruiting |
| Praxis für Prävention und Therapie, Drs Jacob | Villingen-Schwenningen | Germany | Not yet recruiting |
| Region Midtjylland | Aarhus N | Denmark | Not yet recruiting |
| Sanos A/S | Gandrup | Denmark | Not yet recruiting |
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Not yet recruiting |
| Region Sjaelland | Koege | Denmark | Not yet recruiting |
| Region Syddanmark | Odense C | Denmark | Not yet recruiting |
| Centro Periférico de Especialidades Bola Azul | Almería | Spain | Recruiting |
| Consorci D'atencio Primaria De Salut Barcelona Esquerra | Barcelona | Spain | Recruiting |
| Eba Vallcarca Slp | Barcelona | Spain | Recruiting |
| Centre d'Atenció Primària Canet de Mar | Barcelona | Spain | Recruiting |
| Centre d'Atenció Primària Sarrià | Barcelona | Spain | Recruiting |
| Centro De Salud Cabra Matrona Antonia Mesa Fernandez | Cabra | Spain | Recruiting |
| Hospital Nisa Sevilla Aljarafe | Castilleja De La Cuesta | Spain | Recruiting |
| Centro de Salud San Juan de la Cruz | Pozuelo de Alarcón | Spain | Recruiting |
| CAP Turó de Can Mates | San Cugat del Vallés | Spain | Recruiting |
| Centro de Salud La Cuesta | Santa Cruz de Tenerife | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Recruiting |
| Equip D'assistencia Primaria Vic S.L.P. | Vic | Spain | Recruiting |
| General Hospital of Athens "G. Gennimatas" | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Recruiting |
| General Hospital Of Chios Skylitseio | Chios | Greece | Recruiting |
| University General Hospital of Ioannina | Ioannina | Greece | Recruiting |
| City Hospital Kliniki Monoprosopi I.K.E. | Kalamata | Greece | Recruiting |
| General University Hospital of Larissa | Larissa | Greece | Recruiting |
| Athens Medical Center S.A. | Paleo Faliro | Greece | Recruiting |
| Nexthealth S.A | Thessaloniki | Greece | Recruiting |
| Thermi Clinic S.A. | Thessaloniki | Greece | Recruiting |
| General Hospital Of Thessloniki G Gennimatas | Thessaloniki | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou | Thessaloniki | Greece | Recruiting |
| Poliklinika Solmed d.o.o. | Grad Zagreb | Croatia | Recruiting |
| Opća bolnica Karlovac | Karlovac | Croatia | Recruiting |
| Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice | Krapinske Toplice | Croatia | Recruiting |
| Klinički bolnički centar Osijek | Osijek | Croatia | Recruiting |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia | Recruiting |
| General Hospital Dr. Josip Bencevic | Slavonski Brod | Croatia | Recruiting |
| Poliklinika za oftalmologiju optometriju i neurologiju Lux | Solin | Croatia | Recruiting |
| Lausmed Kft | Baja | Hungary | Recruiting |
| DRC Kft. | Balatonfüred | Hungary | Recruiting |
| Trial Pharma Kft. | Békéscsaba | Hungary | Recruiting |
| Bekes Varmegyei Koezponti Korhaz | Gyula | Hungary | Recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | Hungary | Recruiting |
| KomplexLabor Kft. | Kecskemét | Hungary | Recruiting |
| Medifarma-98 Kft. | Nyíregyháza | Hungary | Recruiting |
| University of Szeged | Szeged | Hungary | Recruiting |
| Ente Ecclesiastico ospedale generale Regionale Miulli | Acquaviva delle Fonti | Italy | Not yet recruiting |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari | Bari | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Not yet recruiting |
| ASST Fatebenefratelli Sacco | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Not yet recruiting |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny | Bialystok | Poland | Recruiting |
| Optitrial Sp. z o.o. | Chojnice | Poland | Recruiting |
| Reumed Sp. z o.o. | Lublin | Poland | Recruiting |
| Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. | Piotrkow Trybunalski | Poland | Recruiting |
| Metabolica Sp. z o.o. | Tarnów | Poland | Recruiting |
| Nbr Polska Tomasz Klodawski | Warsaw | Poland | Recruiting |
| Clinical Study Center S.C. | Wrocław | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach | Zabrze | Poland | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. | Almada | Portugal | Not yet recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Not yet recruiting |
| Sanfil-Casa De Saude De Santa Filomena S.A. | Coimbra | Portugal | Not yet recruiting |
| Unidade Local De Saude Da Guarda E.P.E. | Guarda | Portugal | Not yet recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. | Guimaraes | Portugal | Not yet recruiting |
| Hospital de S. Francisco S.A. | Leiria | Portugal | Not yet recruiting |
| Hospital Cuf Tejo S.A. | Lisbon | Portugal | Not yet recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. | Lisbon | Portugal | Not yet recruiting |
| Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda | Ponte de Lima | Portugal | Not yet recruiting |
| Hospital CUF Porto S.A. | Porto | Portugal | Not yet recruiting |
| Unidade Local De Saude De Matosinhos E.P.E. | Senhora Da Hora | Portugal | Not yet recruiting |
| Hospor Hospitais Portugueses S.A. | Setubal | Portugal | Not yet recruiting |
| Casa de Saude Sao Mateus S.A. | Viseu | Portugal | Not yet recruiting |
| Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia | Baia Mare | Romania | Recruiting |
| Diabet Center S.R.L. | Brasov | Romania | Recruiting |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti | Bucharest | Romania | Recruiting |
| Grandmed S.R.L. | Oradea | Romania | Recruiting |
| Bella Praxis S.R.L. | Paşcani | Romania | Recruiting |
| Medis Muntenia S.R.L. | Pitesti | Romania | Recruiting |
| Diabmed Dr. Popescu Alexandrina S.R.L. | Ploiesti | Romania | Recruiting |
| CMI Dr. Busegeanu Mihaela Magdalena | Ploieşti | Romania | Recruiting |
| DIADA, s.r.o. | Bardejov | Slovakia | Recruiting |
| Human-Care s.r.o. | Kosice 1 | Slovakia | Recruiting |
| DIAMARTIN, s. r. o. | Martin | Slovakia | Recruiting |
| Dentavia s.r.o. | Poprad | Slovakia | Recruiting |
| Ambulancia diabetologie a poruch latkovej premeny a vyzivy - MUDr. Gabriela Zimova | Spisska Nova Ves | Slovakia | Recruiting |
| Sirco 2 s.r.o. | Svidnik | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.