AMBITION 1: A research study investigating how well zenagamtide lowers blood sugar and body weight compared to placebo in people with type 2 diabetes treated with diet and exercise.
Key facts
- Where
- Katowice, Malbork, Oswiecim, Plock, Staszow, Świnoujście és Warsaw, LengyelországSee the 7 sites
- Phase
- 3. fázis
Where in Lengyelország
- Pro Familia Altera Sp. z o.o.Katowice, LengyelországToborzás még nem indult
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. oMalbork, LengyelországToborzás még nem indult
- Formed 2 Sp. z o.o.Oswiecim, LengyelországToborzás még nem indult
- Cbk Med Clinic Sp. z o.o.Plock, LengyelországToborzás még nem indult
- Velocity Nova Sp. z o.o.Staszow, LengyelországToborzás még nem indult
- Balticmed Świnoujście Sp. z o. o.Świnoujście, LengyelországToborzás még nem indult
- Nbr Polska Tomasz KlodawskiWarsaw, LengyelországToborzás még nem indult
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 2026-525470-18-00
- Record updated
- 2026. november 6.
- Original description
To confirm superiority of [CCI] zenagamtide, each versus placebo on glycated haemoglobin (HbA1c) in participants with type 2 diabetes (T2D) not in adequate glycaemic control on diet and exerciseRead full original descriptionShow less
Efficacy and safety of zenagamtide s.c. once weekly compared to placebo in participants with type 2 diabetes inadequately controlled on diet and exercise (AMBITION 1)
To confirm superiority of [CCI] zenagamtide, each versus placebo on glycated haemoglobin (HbA1c) in participants with type 2 diabetes (T2D) not in adequate glycaemic control on diet and exercise
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) ≥ 30 days before screening; Treatment naïve to any glucose-lowering medication(s); Glycated haemoglobin (HbA1c) [CCI] as determined by central laboratory at screening; [CCI].
Exclusion: Current treatment or history of treatment with any medication for the indication of diabetes, or 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 for any indication. However, previous insulin treatment during Gestational Diabetes Mellitus is allowed; Treatment with any medication for the indication of obesity [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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination; Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening; Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening; [CCI] as determined by 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; [CCI].