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A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

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Novo Nordisk

Status and phase

Not yet enrolling
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: UBT251
Drug: Semaglutide Placebo
Drug: UBT251 Placebo
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT07668388
2026-525465-42 (Other Identifier)
NN9559-8577
U1111-1329-7014 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 4 patient groups, including a placebo group

UBT251
Experimental group
Description:
Participants will receive once weekly UBT251 subcutaneously.
Treatment:
Drug: UBT251
UBT251 Placebo
Placebo Comparator group
Description:
Participants will receive once weekly UBT251 placebo subcutaneously.
Treatment:
Drug: UBT251 Placebo
Semaglutide
Active Comparator group
Description:
Participants will receive once weekly semaglutide subcutaneously.
Treatment:
Drug: Semaglutide
Semaglutide Placebo
Placebo Comparator group
Description:
Participants will receive once weekly semaglutide placebo subcutaneously.
Treatment:
Drug: Semaglutide Placebo

Trial contacts and locations

69

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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