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
Key facts
- Where
- Biatorbágy, Budapest XIII, Budapest XXI, Pécs és Szolnok, MagyarországSee the 5 sites
- Phase
- 3. fázis
Where in Magyarország
- Biatros Kft.Biatorbágy, MagyarországTaking people
- Central Hospital Of Northern Pest Military HospitalBudapest XIII, MagyarországTaking people
- Szatmari-Med Kft.Budapest XXI, MagyarországTaking people
- University of PecsPécs, MagyarországTaking people
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointézetSzolnok, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- EU 2026-525474-20-00
- Record updated
- 2026. november 6.
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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].
Exclusion: 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; Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening; [CCI] as determined by the central laboratory at screening; 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.