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Efficacy and safety of once-weekly subcutaneous UBT251 in participants with type 2 diabetes – a dose-finding study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525465-42-00
Enrollment
110
Registered
2026-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes (T2D)

Brief summary

Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point

Detailed description

Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point, Change in HbA1c from baseline (week 0) to end of treatment (week 40); unit = %-point, Change in HOMA2-IR from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in HOMA2-B from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in fasting plasma glucose (FPG) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = mmol/L, CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -2 to week 0) to week 14-16, week 26-28 and week 38-40, respectively; unit = %-points, Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in body mass index (BMI) from baseline (week 0) to end of treatment (week 40); unit = kg/m2, Change in waist circumference from baseline (week 0) to end of treatment (week 40); unit = cm, Change in waist-to-height ratio (WHtR) from baseline (week 0) to end of treatment (week 40); no unit, Change in systolic blood pressure (SBP) from baseline (week 0) to end of treatment (week 40); unit = mmHg, Change in diastolic blood pressure (DBP) from baseline (week 0) to end of treatment (week 40); unit = mmHg, Change in pulse rate from baseline (week 0) to end of treatment (week 40); unit = beats/min, Change in high sensitivity C-Reactive Protein (hsCRP) from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in total cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in high-density lipoprotein (HDL) cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in low-density lipoprotein (LDL) cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in triglycerides from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in urine albumincreatinine ratio (UACR) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) ; unit = Ratio to baseline, Change in eGFR (creatininecystatin C-based CKD-EPI 2021) from baseline (week 0) to end of treatment (week 40); unit = mL/min/1.73 m2

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point

Secondary

MeasureTime frame
Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point, Change in HbA1c from baseline (week 0) to end of treatment (week 40); unit = %-point, Change in HOMA2-IR from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in HOMA2-B from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in fasting plasma glucose (FPG) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = mmol/L, CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -2 to week 0) to week 14-16, week 26-28 and week 38-40, respectively; unit = %-points, Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 2, 2026