Studies a new weekly medicine, UBT251, for lowering blood sugar in type 2 diabetes
Tests UBT251 against semaglutide or placebo in adults with type 2 diabetes.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Brasov, Bucharest, Craiova, Galati, Satu Mare, and Timisoara, RomaniaSee the 6 sitesAlso in 8 other countries, 64 sites
- Trial code
- NCT07668388
- EU 2026-525465-42-00
- U1111-1329-7014
- Registry title
- A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 300 people, planned
- Started
- 22 Jun 2026
- Expected to end
- 15 Nov 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- UBT251
- UBT251 Placebo
- Semaglutide
- Semaglutide Placebo
- Record updated
- 7 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. 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 take metformin, with or without an SGLT2 inhibitor, to test the medicine UBT251.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Type 2 diabetes diagnosed at least 180 days before screening, with HbA1c of 7.0-10.5 % (53-91 mmol/mol).
- Earlier treatment
- A stable daily dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days before screening. No other diabetes or obesity medicine in the 90 days before screening, except short-term insulin for at most 14 days in a row.
- Biomarker or test result
- HbA1c of 7.0-10.5 % (53-91 mmol/mol) and body mass index of 25.0-50.0 kg/m^2.
Main reasons for not taking part
- Other diabetes or obesity medicines in the 90 days before screening
- Uncontrolled and possibly unstable diabetic retinopathy or maculopathy
- Known hypoglycaemic unawareness (not noticing low blood sugar)
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Male or female (sex assigned at birth, inclusive of all gender identities)
- Age 18-75 years (both inclusive) at the time of signing the informed consent
- Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening
- Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:; metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor
- HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening
- Body mass index between 25.0 kg/m\^2 and 50.0 kg/m\^2 (both inclusive) at screening
Who cannot take part
- Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. 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
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Romania
Also in 8 other countries, 64 sites
- Mariodiab Clinic S.R.L.Brasov, RomaniaTaking people
- Nutrilife S.R.L.Bucharest, RomaniaTaking people
- Top Diabet S.R.L.Craiova, RomaniaTaking people
- Milena Sante S.R.L.Galati, RomaniaTaking people
- Clinica Korall S.R.L.Satu Mare, RomaniaTaking people
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoara, RomaniaTaking people
About the trial
What the trial wants to find out
The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.
The 4 groups in the trial
- UBT251Treatment being tested
Participants will receive once weekly UBT251 subcutaneously.
- UBT251 PlaceboPlacebo, for comparison
Participants will receive once weekly UBT251 placebo subcutaneously.
- SemaglutideExisting treatment, for comparison
Participants will receive once weekly semaglutide subcutaneously.
- Semaglutide PlaceboPlacebo, for comparison
Participants will receive once weekly semaglutide placebo subcutaneously.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study
- Plain-language title
- Studies a new weekly medicine, UBT251, for lowering blood sugar in type 2 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07668388, who can take part
- Record updated
- 7 October 2026