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

June 19, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Castle Hill, New South Wales, Australia, 2154
        • Castle Hill Medical Centre
      • New Lambton Heights, New South Wales, Australia, 2305
        • Hunter Medical Research Institute - Endocrinology and Diabetes
      • Sydney, New South Wales, Australia, 2148
        • Roger Chih Yu Chen
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital - Cardiology Department
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Baker Heart and Diabetes Institute
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Berlin, Germany, 13597
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Bochum, Germany, 44869
        • DSP Bochum, Diabetes- und Stoffwechselpraxis
      • Bünde, Germany, 32257
        • Studiengesellschaft Dres. Könemann/Steinmann GbR
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Hof, Germany, 95030
        • Mesut Durmaz, Hof
      • Mannheim, Germany, 68167
        • CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)
    • Bavaria
      • Amberg, Bavaria, Germany, 92224
        • Versdias - Diabetologikum Amberg
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1032
        • Szent Margit Rendelőintézet Nonprofit Kft.
      • Budapest, Hungary, 1102
        • PVN Kutató Kft.
      • Pécs, Hungary, 7624
        • Pécsi Tudományegyetem ÁOK
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Kielce, Poland, 25-355
        • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar
      • Lublin, Poland, 20-011
        • Clinical Best Solutions Sp. z o.o., Sp. k
      • Oświęcim, Poland, 32-600
        • Formed 2 Sp. z o.o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-049
        • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-879
        • NZOZ Vita-Diabetica Malgorzata Buraczyk
  • Romania
      • Brasov, Romania, 500101
        • Mariodiab Clinic SRL
      • Bucharest, Romania, 013764
        • SC Nutrilife SRL
      • Galati, Romania, 800001
        • S.C Milena Sante SRL
      • Satu Mare, Romania, 440055
        • Clinica Korall S.R.L. Satu Mare
      • Timișoara, Romania, 300723
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
    • Dolj
      • Craiova, Dolj, Romania, 200515
        • S.C. Top Diabet Srl
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Medispektrum s.r.o.
      • Lučenec, Slovakia, 984 01
        • IN-DIA s.r.o.
      • Sabinov, Slovakia, 08301
        • MEDI-DIA s.r.o.
      • Trebišov, Slovakia, 075 01
        • ARETEUS s.r.o.
  • South Korea
      • Gwangju, South Korea, 61453
        • Chosun University Hospital_Endocrinology
      • Seoul, South Korea, 05505
        • Asan Medical Center_Endocrinology
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital_Endocrinology
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Centelles (Barcelona), Spain, 08540
        • Eap Osona Sud Alt Congost S.L.P
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Seville, Spain, 41010
        • H. Infanta Luisa_Endocrino y Obesidad
    • Barcelona
      • Vic, Barcelona, Spain, 08500
        • Equip D'assistencia Primaria Vic S.L.P.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Flourish Research
    • California
      • Fountain Valley, California, United States, 92708
        • Ark Clinical Research
      • Long Beach, California, United States, 90815
        • Ark Clinical Research
      • Los Angeles, California, United States, 90015
        • Los Angeles Institute for Metabolic Research
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
    • Florida
      • Hollywood, Florida, United States, 33021
        • Encore Medical Research LLC
      • Miramar, Florida, United States, 33027
        • South Broward Research LLC
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Inst For Clin Res
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Wilmington, North Carolina, United States, 28401
        • KDCILM, LLC & Accellacare US, Inc.
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC_Fargo
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians, Inc.
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Monroe Biomedical Research, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • LifeDoc Health
    • Texas
      • Austin, Texas, United States, 78745
        • IMA Clinical Research
      • Houston, Texas, United States, 77089
        • Private Practice - Dr. Laila A. Hassan
      • Lampasas, Texas, United States, 76550
        • Radiance Clinical Research
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc
      • San Antonio, Texas, United States, 78258
        • Tekton Research Inc
      • Shavano Park, Texas, United States, 78231
        • Consano Clin Res-Shavano Park
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Washington
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UBT251
Participants will receive once weekly UBT251 subcutaneously.
Drug: UBT251
UBT251 will be administered subcutaneously once-weekly.
Placebo Comparator: UBT251 Placebo
Participants will receive once weekly UBT251 placebo subcutaneously.
Drug: UBT251 Placebo
UBT251 placebo will be administered subcutaneously once-weekly.
Active Comparator: Semaglutide
Participants will receive once weekly semaglutide subcutaneously.
Drug: Semaglutide
Semaglutide will be administered subcutaneously once-weekly.
Placebo Comparator: Semaglutide Placebo
Participants will receive once weekly semaglutide placebo subcutaneously.
Drug: Semaglutide Placebo
Semaglutide placebo will be administered subcutaneously once-weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UBT251: Relative change in body weight
Time Frame: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251: Change in body weight
Time Frame: From baseline (week 0) to week 40
Measured as kilogram (kg).
From baseline (week 0) to week 40
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.
From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in HbA1c
Time Frame: From baseline (week 0) to week 40
Measured as %-point.
From baseline (week 0) to week 40
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
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.
From baseline (week 0) to week 40
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).
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))
Time Frame: From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively
Measured as %-points.
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
Time Frame: From baseline (week 0) to week 40
Measured as %.
From baseline (week 0) to week 40
UBT251 vs placebo: Change in body weight
Time Frame: From baseline (week 0) to week 40
Measured as kg.
From baseline (week 0) to week 40
Change in body mass index (BMI)
Time Frame: From baseline (week 0) to week 40
Measured as Kilograms per square meter (kg/m^2).
From baseline (week 0) to week 40
Change in waist circumference
Time Frame: From baseline (week 0) to week 40
Measured as centimeter (cm).
From baseline (week 0) to week 40
Change in waist-to-height ratio (WHtR)
Time Frame: From baseline (week 0) to week 40
From baseline (week 0) to week 40
Change in systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to week 40
Measured as millimetres of mercury (mmHg).
From baseline (week 0) to week 40
Change in diastolic blood pressure (DBP)
Time Frame: From baseline (week 0) to week 40
Measured as mmHg.
From baseline (week 0) to week 40
Change in pulse rate
Time Frame: From baseline (week 0) to week 40
Measured in beats/min.
From baseline (week 0) to week 40
Change in high sensitivity C-Reactive Protein (hsCRP)
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in total cholesterol
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in high-density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in low-density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
Change in triglycerides
Time Frame: From baseline (week 0) to week 40
Measured as ratio to baseline.
From baseline (week 0) to week 40
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.
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)
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).
From baseline (week 0) to week 40
Number of treatment-emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to week 46
Measured as number of events.
From baseline (week 0) to week 46

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

October 4, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9559-8577
  • U1111-1329-7014 (Other Identifier: World Health Organization (WHO))
  • 2026-525465-42 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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