A Phase 2 interventional study of UBT251 and UBT251 Placebo in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Recruiting at 70 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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.
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor.
Exclusion Criteria:
Participants will receive once weekly UBT251 subcutaneously.
Drug: UBT251
Participants will receive once weekly UBT251 placebo subcutaneously.
Drug: UBT251 Placebo
Participants will receive once weekly semaglutide subcutaneously.
Drug: Semaglutide
Participants will receive once weekly semaglutide placebo subcutaneously.
Drug: Semaglutide Placebo
UBT251 will be administered subcutaneously once-weekly.
UBT251 placebo will be administered subcutaneously once-weekly.
Semaglutide will be administered subcutaneously once-weekly.
Semaglutide placebo will be administered subcutaneously once-weekly.
UBT251: Change in glycated haemoglobin (HbA1c)
Measured as percentage (%)-point.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
UBT251: Relative change in body weight
Measured as %.
Time frame: From baseline (week 0) to week 40
UBT251: Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to week 40
UBT251 vs placebo: Change in HbA1c
Measured as %-point.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in HbA1c
Measured as %-point.
Time frame: From baseline (week 0) to week 40
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in homeostasis model assessment of beta-cell function (HOMA2-B)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in fasting plasma glucose (FPG)
Measured as millimoles per litre (mmol/L).
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL))
Measured as %-points.
Time frame: From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively
UBT251 vs placebo: Relative change in body weight
Measured as %.
Time frame: From baseline (week 0) to week 40
UBT251 vs placebo: Change in body weight
Measured as kg.
Time frame: From baseline (week 0) to week 40
Change in body mass index (BMI)
Measured as Kilograms per square meter (kg/m\^2).
Time frame: From baseline (week 0) to week 40
Change in waist circumference
Measured as centimeter (cm).
Time frame: From baseline (week 0) to week 40
Change in waist-to-height ratio (WHtR)
Time frame: From baseline (week 0) to week 40
Change in systolic blood pressure (SBP)
Measured as millimetres of mercury (mmHg).
Time frame: From baseline (week 0) to week 40
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to week 40
Change in pulse rate
Measured in beats/min.
Time frame: From baseline (week 0) to week 40
Change in high sensitivity C-Reactive Protein (hsCRP)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in total cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in high-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in triglycerides
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in urine albumin creatinine ratio (UACR)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in eGFR (creatinine-cystatin C-based CKD-EPI 2021)
Measured in milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
Time frame: From baseline (week 0) to week 40
Number of treatment-emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From baseline (week 0) to week 46
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Novo Nordisk A/S