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
Key facts
- Where
- Baja, Balatonfüred, Békéscsaba, Gyula, Kaposvár, Kecskemét, Nyíregyháza és Szeged, MagyarországSee the 8 sites
- Phase
- 3. fázis
Where in Magyarország
- Lausmed KftBaja, MagyarországTaking people
- DRC Kft.Balatonfüred, MagyarországTaking people
- Trial Pharma Kft.Békéscsaba, MagyarországTaking people
- Bekes Varmegyei Koezponti KorhazGyula, MagyarországTaking people
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, MagyarországTaking people
- KomplexLabor Kft.Kecskemét, MagyarországTaking people
- Medifarma-98 Kft.Nyíregyháza, MagyarországTaking people
- University of SzegedSzeged, 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 2026-525472-26-00
- Record updated
- 2026. november 6.
- Original description
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 bothRead full original descriptionShow less
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)
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
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) [CCI] prior to screening; Haemoglobin (HbA1c) [CCI] as determined by central laboratory at screening; [CCI]; [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; 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].