2026-525474-20-00RecruitingPhase 3
AMBITION 4: A research study investigating how well zenagamtide at lower dose levels lowers blood sugar and body weight compared to semaglutide at lower dose levels 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 lower dose levels in participants with type 2 diabetes inadequately controlled on metformin, SGLT2i, or both (AMBITION 4)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026
Brief summary (registry, in English)
To confirm non-inferiority of [CCI] mg zenagamtide versus [CCI] mg semaglutide and [CCI] mg zenagamtide versus [CCI] mg semaglutide on change in glycated haemoglobin A1c (HbA1c) in participants with type 2 diabetes (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
- 245 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- 29 Oct 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- EU CT number
- 2026-525474-20-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 245
- 36 sites in 6 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
- Men and women
- Disease stage
- Type 2 diabetes diagnosed at least 180 days before screening, with blood sugar 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 treatment or amylin analogues before screening.
- Biomarker or test result
- A set 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, or planning pregnancy, or of childbearing age and not using adequate contraception
- Heart attack, stroke, mini-stroke or hospital stay for unstable angina within 60 days before screening
- Severe chronic heart failure (NYHA Class IV)
- Planned procedure to reopen heart, neck or leg arteries
- Eye disease from diabetes 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.
Lab values
- [CCI] as determined by the central laboratory 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.
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) for [CCI] prior to screening.
- Glycated haemoglobin (HbA1c) [CCI] as determined by central laboratory at screening.
- [CCI]
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD | Blagoevgrad | Bulgaria | Recruiting |
| Individualna praktika za specializirana medicinska pomost d-r Ivan Danov EOOD | Burgas | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Pazardzik AD | Pazardzhik | Bulgaria | Recruiting |
| Medical Center Academica 2008 EOOD | Pleven | Bulgaria | Recruiting |
| Specialized Outpatient Clinic For Individual Practice In Endocrinology And Metabolic Diseases D-R Mariya Kalinkova EOOD | Sofia | Bulgaria | Recruiting |
| Endomedical Center OOD | Sofia | Bulgaria | Recruiting |
| Medical Center New Rehabilitation Center EOOD | Stara Zagora | Bulgaria | Recruiting |
| Equip D'atencio Primaria Barcelona Sardenya S.L.P. | Barcelona | Spain | Recruiting |
| Clinica Bofill S.L. | Girona | Spain | Recruiting |
| CAP Alhambra | L'Hospitalet de Llobregat (Barcelona) | Spain | Recruiting |
| CS Monzón Urbano | Monzón | Spain | Recruiting |
| Area De Salud De Salamanca | Salamanca | Spain | Recruiting |
| Hospital Quironsalud Infanta Luisa | Sevilla | Spain | Recruiting |
| Poliklinika Solmed d.o.o. | Grad Zagreb | Croatia | Recruiting |
| Poliklinika MEDIKOL | Grad Zagreb | Croatia | Recruiting |
| Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu | Osijek | Croatia | Recruiting |
| Pula General Hospital Ospedale Generale di Pola | Pula - Pola | Croatia | Recruiting |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia | Recruiting |
| Specijalna Bolnica Medico | Rijeka | Croatia | Recruiting |
| Opca Bolnica Varazdin | Varazdin | Croatia | Recruiting |
| Biatros Kft. | Biatorbágy | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital | Budapest XIII | Hungary | Recruiting |
| Szatmari-Med Kft. | Budapest XXI | Hungary | Recruiting |
| University of Pecs | Pécs | Hungary | Recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet | Szolnok | Hungary | Recruiting |
| R57 Sp. z o.o. | Cracow | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej | Leczna | Poland | Recruiting |
| Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o | Malbork | Poland | Recruiting |
| Velocity Nova Sp. z o.o. | Skierniewice | Poland | Recruiting |
| Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA | Sosnowiec | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Not yet recruiting |
| ICB Instituto Cardiovascular De Braga Lda. | Braga | Portugal | Not yet recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. | Lisbon | Portugal | Not yet recruiting |
| Unidade Local De Saude De Matosinhos E.P.E. | Senhora Da Hora | Portugal | Not yet recruiting |
| Spamedic Sociedade Prestadora De Assistencia Medica Lda. | Torres Novas | Portugal | Not yet recruiting |
| Casa de Saude Sao Mateus S.A. | Viseu | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.