"AMBITION 2: A research study investigating how well zenagamtide lowers blood sugar and body weight compared to placebo in people with type 2 diabetes and chronic kidney disease treated with once daily basal insulin alone or in combination with metformin, SGLT2i, or both."
Key facts
- Where
- Chorzów, Gdansk, Lublin, Olsztyn, Oswiecim, Swiecie, Warsaw és Zabrze, LengyelországSee the 9 sites
- Phase
- 3. fázis
Where in Lengyelország
- M2M Med. Badania Sp. z o.o.Chorzów, LengyelországTaking people
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországTaking people
- Zanamed Medical Clinic Sp. z o.o.Lublin, LengyelországTaking people
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.Olsztyn, LengyelországTaking people
- Wojewódzki Szpital Specjalistyczny w OlsztynieOlsztyn, LengyelországTaking people
- Formed 2 Sp. z o.o.Oswiecim, LengyelországTaking people
- Nowy Szpital Sp. z o.o.Swiecie, LengyelországTaking people
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, LengyelországTaking people
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrze, LengyelországTaking 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 2026-525471-13-00
- Record updated
- 2026. november 6.
- Original description
To confirm superiority of [CCI] zenagamtide, each versus placebo on change in glycated haemoglobin (HbA1c) in participants with T2D and CKD not in adequate glycaemic control on once-daily basal insulin alone or in combination with metformin, SGLT2i, or both.Read full original descriptionShow less
Efficacy and safety of zenagamtide s.c. once weekly compared to placebo in participants with type 2 diabetes and chronic kidney disease inadequately controlled on once daily basal insulin alone or in combination with metformin, SGLT2i, or both (AMBITION 2)
To confirm superiority of [CCI] zenagamtide, each versus placebo on change in glycated haemoglobin (HbA1c) in participants with T2D and CKD not in adequate glycaemic control on once-daily basal insulin alone or in combination with metformin, SGLT2i, or both.
Inclusion: 1 Male or female (sex assigned at birth); 2 Age 18 years or above at the time of signing the informed consent; 3 Diagnosed with type 2 diabetes (T2D) ≥ 180 days before screening; 4 HbA1c [CCI] as determined by central laboratory at screening; 5 [CCI]; 6 On stable once-daily dose of basal insulin (minimum of 0.25 U/kg/day or 20 U/day) at the investigator’s discretion alone or in combination with metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i) or both (at stable effective or maximum tolerated dose as judged by the investigator) [CCI] prior to screening. Basal insulin dose is considered stable when all doses during this period are within the range defined by ±20%; 7 [CCI], as determined by central laboratory at screening; 8 History of chronic kidney disease based on medical records or as judged by the investigator; 9 Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Exclusion: 11 Combination use of an ACE inhibitor and an ARB within 30 days prior to screening; 2 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 or short-term insulin treatment for a maximum of 14 consecutive days is allowed; 3 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; 4 Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-vascular endothelial growth factor 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; 5 Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening; 9 Any primary or secondary kidney disease requiring immunosuppressive therapy [CCI] prior to screening; 6 Chronic heart failure classified as being in New York Heart Association Class IV at screening; 1 Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method; 10 Chronic or intermittent haemodialysis or peritoneal dialysis [CCI] before screening; 7 Planned coronary, carotid or peripheral artery revascularisation; 8 Lupus nephritis or antineutrophil cytoplasmic (ANCA)-associated vasculitis.