Not yet recruitingPhase 2

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

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

Lead sponsor

Novo Nordisk A/S

Assets

Semaglutide / UBT251

Listed sites

Recruiting sites

Estimated enrollment

300

Study population

Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-50•HbA1c 7-10.5%

Primary endpoint

•UBT251

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07668388

Org study IDNN9559-8577

Secondary ID2026-525465-42European Medical Agency (EMA)

Secondary IDU1111-1329-7014World Health Organization (WHO)

Timeline

Milestones

Study start2026-06-22estimated

Study first posted2026-06-25actual

Last update posted2026-06-25actual

Primary completion2027-10-04estimated

Study completion2027-11-15estimated

Assets

Investigational agents

Semaglutide UBT251

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Renal / kidney

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

7 endpoints

Secondary/protocol endpoint

UBT251: Relative change in body weight

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

percent change from baseline, improvement

Secondary/protocol endpoint

UBT251: Change in body weight

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

change from baseline, improvement

Secondary/protocol endpoint

UBT251 vs placebo: Relative change in body weight

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

percent change from baseline, improvement

Secondary/protocol endpoint

UBT251 vs placebo: Change in body weight

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

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

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

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio (WHtR)

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

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Renal / kidney

2 endpoints

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in pulse rate

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

change from baseline, improvement

Secondary/protocol endpoint

Change in high sensitivity C-Reactive Protein (hsCRP)

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

change from baseline, improvement

Secondary/protocol endpoint

Change in total cholesterol

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

change from baseline, improvement

Secondary/protocol endpoint

Change in high-density lipoprotein (HDL) cholesterol

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

change from baseline, improvement

Secondary/protocol endpoint

Change in low-density lipoprotein (LDL) cholesterol

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

change from baseline, improvement

Secondary/protocol endpoint

Change in triglycerides

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

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

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

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.