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Taking people in RomaniaPhase 3

Zenagamtide once a week for type 2 diabetes not controlled by diet and exercise

Tests zenagamtide against placebo in adults with type 2 diabetes.

Key facts

Who runs it
Novo Nordisk A/S
Where
Bucharest, Oradea, Reghin, Sibiu, and Târgu Mureş, RomaniaSee the 6 sitesAlso in 7 other countries, 42 sites
Trial code
Registry title
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
Status
Not yet recruiting
Phase
Phase 3
People taking part
200 people, planned
Started
10 Nov 2026
Expected to end
28 Aug 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Zenagamtide
  • 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 11 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) greater than or equal to (≥) 30 days before screening
  • Treatment naïve to any glucose-lowering medication(s)

Who cannot take part

  • 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 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
  • 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 7 other countries, 42 sites

  • Institutul de pneumoftiziologie Marius NastaBucharest, RomaniaTaking people
  • Nutrilife S.R.L.Bucharest, RomaniaTaking people
  • Diabdana S.R.L.Oradea, RomaniaTaking people
  • Poli Cardinal Med S.R.L.Reghin, RomaniaTaking people
  • Gensan S.R.L.Sibiu, RomaniaTaking people
  • Mediab S.R.L.Târgu Mureş, RomaniaTaking people

About the trial

What the trial wants to find out

This study is being done to look at how well zenagamtide lowers blood sugar levels and body weight in people with type 2 diabetes when compared to placebo. Participants will either get zenagamtide, the treatment being tested or placebo, a treatment that has no active medicine in it. Which treatment participants get is decided by chance. Zenagamtide is a new medicine that doctors cannot prescribe yet, but it has been tested in humans before.

The 2 groups in the trial

  • ZenagamtideTreatment being tested

    Participants will receive zenagamtide subcutaneously.

  • PlaceboPlacebo, for comparison

    Participants will receive placebo matched to zenagamtide subcutaneously.

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 Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
Plain-language title
Zenagamtide once a week for type 2 diabetes not controlled by diet and exerciseGenerated from the registry record. The registry title is the official one.
Record updated
12 November 2026