2026-525470-18-00RecruitingPhase 3
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.
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 4 Nov 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- EU CT number
- 2026-525470-18-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 85
- 19 sites in 3 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 who have never taken any glucose-lowering medicine and whose blood sugar is not well controlled with diet and exercise alone.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Type 2 diabetes diagnosed at least 30 days before screening, with blood sugar (HbA1c) not adequately controlled on diet and exercise.
- Earlier treatment
- People must never have had any glucose-lowering medicine. People who have had GLP-1 based treatments or amylin analogues cannot join. Insulin during gestational diabetes is allowed.
- Biomarker or test result
- An HbA1c result measured at screening by the central laboratory; the exact range is not given in the record.
Main reasons for not taking part
- Pregnant, breast-feeding, planning pregnancy, or able to become pregnant without adequate contraception
- Any past or current medicine for diabetes, or GLP-1 based or amylin analogue treatment for any reason
- Medicine for obesity before screening
- Eye damage from diabetes treated within 180 days before screening, or expected to need treatment within 180 days after
- Heart attack, stroke, mini-stroke or hospital stay for unstable angina within 60 days before screening
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
- 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.
Other illness
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
Lab values
- [CCI] as determined by 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.
- [CCI]
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) ≥ 30 days before screening.
- Treatment naïve to any glucose-lowering medication(s).
- 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 (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pro Familia Altera Sp. z o.o. | Katowice | Poland | Not yet recruiting |
| Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o. o | Malbork | Poland | Not yet recruiting |
| Formed 2 Sp. z o.o. | Oswiecim | Poland | Not yet recruiting |
| Cbk Med Clinic Sp. z o.o. | Plock | Poland | Not yet recruiting |
| Velocity Nova Sp. z o.o. | Staszow | Poland | Not yet recruiting |
| Balticmed Świnoujście Sp. z o. o. | Świnoujście | Poland | Not yet recruiting |
| Nbr Polska Tomasz Klodawski | Warsaw | Poland | Not yet recruiting |
| Nutrilife S.R.L. | Bucharest | Romania | Recruiting |
| Institutul de pneumoftiziologie Marius Nasta | Bucharest | Romania | Recruiting |
| Diabdana S.R.L. | Oradea | Romania | Recruiting |
| Poli Cardinal Med S.R.L. | Reghin | Romania | Recruiting |
| Gensan S.R.L. | Sibiu | Romania | Recruiting |
| Mediab S.R.L. | Târgu Mureş | Romania | Recruiting |
| Diabint s.r.o. | Bytca | Slovakia | Recruiting |
| Kardio-Sanus spol. s r.o. | Devinska Nova Ves | Slovakia | Recruiting |
| Univerzitna nemocnica L. Pasteura Kosice | Košice | Slovakia | Recruiting |
| FUNKYSTUFF s.r.o. | Nové Zámky | Slovakia | Recruiting |
| DEImedi, s. r. o. | Šurany | Slovakia | Recruiting |
| JAL s.r.o. | Trnava | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.