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Taking people in RomaniaPhase 3

Zenagamtide compared with semaglutide for type 2 diabetes not controlled by current treatment

Compares zenagamtide with semaglutide in adults with type 2 diabetes on metformin or SGLT2i.

Key facts

Who runs it
Novo Nordisk A/S
Where
Baia Mare, Brasov, Bucharest, Oradea, Paşcani, Pitesti, Ploiesti, and Ploieşti, RomaniaSee the 8 sitesAlso in 21 other countries, 222 sites
Trial code
Registry title
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
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,200 people, planned
Started
10 Nov 2026
Expected to end
8 Aug 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Zenagamtide
  • Semaglutide
  • Placebo
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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) above or equal to 180 days before screening
  • On stable daily dose(s) of metformin, sodium-glucose transport 2 (SGLT2) inhibitor, or both (at effective or maximum tolerated dose as judged by the investigator) prior to screening
  • Glycated haemoglobin (HbA1c) as determined by central laboratory at screening

Who cannot take part

  • 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 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 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

Where in Romania

Also in 21 other countries, 222 sites

  • Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop LaviniaBaia Mare, RomaniaTaking people
  • Diabet Center S.R.L.Brasov, RomaniaTaking people
  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu BucurestiBucharest, RomaniaTaking people
  • Grandmed S.R.L.Oradea, RomaniaTaking people
  • Bella Praxis S.R.L.Paşcani, RomaniaTaking people
  • Medis Muntenia S.R.L.Pitesti, RomaniaTaking people
  • Diabmed Dr. Popescu Alexandrina S.R.L.Ploiesti, RomaniaTaking people
  • CMI Dr. Busegeanu Mihaela MagdalenaPloieşti, RomaniaTaking people

About the trial

What the trial wants to find out

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will get one of the following: Zenagamtide (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator).

The 3 groups in the trial

  • ZenagamtideTreatment being tested

    Participants will receive zenagamtide subcutaneously once weekly

  • SemaglutideExisting treatment, for comparison

    Participants will receive semaglutide subcutaneously once weekly

  • PlaceboPlacebo, for comparison

    Participants will receive placebo matched to semaglutide or zenagamtide subcutaneously once weekly

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Zenagamtide compared with semaglutide for type 2 diabetes not controlled by current treatmentGenerated from the registry record. The registry title is the official one.
Record updated
12 November 2026