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

NCT07668388
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
300
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Lead sponsor
Novo Nordisk A/S
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Start date
2026-06-22
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Number of sites
70
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Summary
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.
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Short title
A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes
clinicaltrials.gov
Official title
Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-15
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First posted
2026-06-25
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Registry last updated
2026-08-10
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Primary completion date
2027-10-04
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Start date
2026-06-22
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Number of sites
70
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07668388
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ClinicalTrials.gov ID
NCT07668388
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. UBT251: Change in glycated haemoglobin (HbA1c)

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

    Measured as percentage (%)-point.

  1. UBT251: Relative change in body weight

    Timeframe: From baseline (week 0) to week 40

    Measured as %.

  2. UBT251: Change in body weight

    Timeframe: From baseline (week 0) to week 40

    Measured as kilogram (kg).

  3. UBT251 vs placebo: Change in HbA1c

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

    Measured as %-point.

  4. Change in HbA1c

    Timeframe: From baseline (week 0) to week 40

    Measured as %-point.

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

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

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

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  7. Change in fasting plasma glucose (FPG)

    Timeframe: 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))

    Timeframe: 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

    Timeframe: From baseline (week 0) to week 40

    Measured as %.

  10. UBT251 vs placebo: Change in body weight

    Timeframe: From baseline (week 0) to week 40

    Measured as kg.

  11. Change in body mass index (BMI)

    Timeframe: From baseline (week 0) to week 40

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

  12. Change in waist circumference

    Timeframe: From baseline (week 0) to week 40

    Measured as centimeter (cm).

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

    Timeframe: From baseline (week 0) to week 40

  14. Change in systolic blood pressure (SBP)

    Timeframe: From baseline (week 0) to week 40

    Measured as millimetres of mercury (mmHg).

  15. Change in diastolic blood pressure (DBP)

    Timeframe: From baseline (week 0) to week 40

    Measured as mmHg.

  16. Change in pulse rate

    Timeframe: From baseline (week 0) to week 40

    Measured in beats/min.

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

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  18. Change in total cholesterol

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

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

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

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

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  21. Change in triglycerides

    Timeframe: From baseline (week 0) to week 40

    Measured as ratio to baseline.

  22. Change in urine albumin creatinine ratio (UACR)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: From baseline (week 0) to week 46

    Measured as number of events.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Flourish ResearchBirmingham, United StatesRecruiting
  • Ark Clinical ResearchFountain Valley, United StatesRecruiting
  • Ark Clinical ResearchLong Beach, United StatesRecruiting
  • Los Angeles Institute for Metabolic ResearchLos Angeles, United StatesRecruiting
  • Catalina Research Institute, LLCMontclair, United StatesRecruiting
  • Encore Medical Research LLCHollywood, United StatesRecruiting
  • South Broward Research LLCMiramar, United StatesRecruiting
  • Encore Medical Research of WestonWeston, United StatesRecruiting
  • Midwest Inst For Clin ResIndianapolis, United StatesNot yet recruiting
  • Cotton O'Neil Diabetes & EndocrinologyTopeka, United StatesRecruiting
  • MD Medical ResearchOxon Hill, United StatesRecruiting
  • PharmQuestGreensboro, United StatesNot yet recruiting
  • KDCILM, LLC & Accellacare US, Inc.Wilmington, United StatesRecruiting
  • Plains Clinical Research Center, LLC_FargoFargo, United StatesNot yet recruiting
  • Preferred Primary Care Physicians, Inc.Uniontown, United StatesRecruiting
  • Monroe Biomedical Research, LLCNorth Charleston, United StatesRecruiting
  • LifeDoc HealthMemphis, United StatesRecruiting
  • IMA Clinical ResearchAustin, United StatesRecruiting
  • Houston, United StatesRecruiting
  • Radiance Clinical ResearchLampasas, United StatesRecruiting
  • Quality Research IncSan Antonio, United StatesRecruiting
  • Tekton Research IncSan Antonio, United StatesRecruiting
  • Consano Clin Res-Shavano ParkShavano Park, United StatesRecruiting
  • Chrysalis Clinical ResearchSt. George, United StatesRecruiting
  • The Vancouver ClinicVancouver, United StatesNot yet recruiting

And 45 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2026-525465-42
  • U1111-1329-7014
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)