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NCT Number: NCT07668388

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Castle Hill Medical Centre, Castle Hill, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UBT251

Drug

UBT251 will be administered subcutaneously once-weekly.

UBT251 Placebo

Drug

UBT251 placebo will be administered subcutaneously once-weekly.

semaglutide

Drug

Semaglutide will be administered subcutaneously once-weekly.

Semaglutide Placebo

Drug

Semaglutide placebo will be administered subcutaneously once-weekly.

Primary outcomes

  1. UBT251: Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

    Measured as percentage (%)-point.

Secondary outcomes

  1. UBT251: Relative change in body weight

    Time frame: From baseline (week 0) to week 40

    Measured as %.

  2. UBT251: Change in body weight

    Time frame: From baseline (week 0) to week 40

    Measured as kilogram (kg).

  3. UBT251 vs placebo: Change in HbA1c

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

    Measured as %-point.

  4. Change in HbA1c

    Time frame: From baseline (week 0) to week 40

    Measured as %-point.

  5. Change in homeostasis model assessment of insulin resistance (HOMA2-IR)

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  6. Change in homeostasis model assessment of beta-cell function (HOMA2-B)

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  7. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

    Measured as millimoles per litre (mmol/L).

  8. CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL))

    Time frame: From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively

    Measured as %-points.

  9. UBT251 vs placebo: Relative change in body weight

    Time frame: From baseline (week 0) to week 40

    Measured as %.

  10. UBT251 vs placebo: Change in body weight

    Time frame: From baseline (week 0) to week 40

    Measured as kg.

  11. Change in body mass index (BMI)

    Time frame: From baseline (week 0) to week 40

    Measured as Kilograms per square meter (kg/m^2).

  12. Change in waist circumference

    Time frame: From baseline (week 0) to week 40

    Measured as centimeter (cm).

  13. Change in waist-to-height ratio (WHtR)

    Time frame: From baseline (week 0) to week 40

  14. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to week 40

    Measured as millimetres of mercury (mmHg).

  15. Change in diastolic blood pressure (DBP)

    Time frame: From baseline (week 0) to week 40

    Measured as mmHg.

  16. Change in pulse rate

    Time frame: From baseline (week 0) to week 40

    Measured in beats/min.

  17. Change in high sensitivity C-Reactive Protein (hsCRP)

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  18. Change in total cholesterol

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  19. Change in high-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  20. Change in low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  21. Change in triglycerides

    Time frame: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  22. Change in urine albumin creatinine ratio (UACR)

    Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

    Measured as ratio to baseline.

  23. Change in eGFR (creatinine-cystatin C-based CKD-EPI 2021)

    Time frame: From baseline (week 0) to week 40

    Measured in milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).

  24. Number of treatment-emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to week 46

    Measured as number of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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