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Diabetes Mellitus, Type 2Phase 2NCT07668388

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

A Phase 2 study testing UBT251 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 70 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
UBT251 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
70 sitesin 9 countries
Study dates
22 Jun 2026to 15 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

70 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

70 sites in 9 countries

United States25 sites, 25 recruiting

  • IMA Clinical Research

    Austin, Texas, 78745

    Recruiting

  • Flourish Research

    Birmingham, Alabama, 35205

    Recruiting

  • Plains Clinical Research Center, LLC_Fargo

    Fargo, North Dakota, 58104

    Not yet recruiting

  • Ark Clinical Research

    Fountain Valley, California, 92708

    Recruiting

  • PharmQuest

    Greensboro, North Carolina, 27408

    Not yet recruiting

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

    Recruiting

  • Private Practice - Dr. Laila A. Hassan

    Houston, Texas, 77089

    Recruiting

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

    Not yet recruiting

  • Radiance Clinical Research

    Lampasas, Texas, 76550

    Recruiting

  • Ark Clinical Research

    Long Beach, California, 90815

    Recruiting

  • Los Angeles Institute for Metabolic Research

    Los Angeles, California, 90015

    Recruiting

  • LifeDoc Health

    Memphis, Tennessee, 38115

    Recruiting

  • South Broward Research LLC

    Miramar, Florida, 33027

    Recruiting

  • Catalina Research Institute, LLC

    Montclair, California, 91763

    Recruiting

  • Monroe Biomedical Research, LLC

    North Charleston, South Carolina, 29406

    Recruiting

  • MD Medical Research

    Oxon Hill, Maryland, 20745

    Recruiting

  • Quality Research Inc

    San Antonio, Texas, 78209

    Recruiting

  • Tekton Research Inc

    San Antonio, Texas, 78258

    Recruiting

  • Consano Clin Res-Shavano Park

    Shavano Park, Texas, 78231

    Recruiting

  • Chrysalis Clinical Research

    St. George, Utah, 84790

    Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

    Recruiting

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

    Recruiting

  • The Vancouver Clinic

    Vancouver, Washington, 98664

    Not yet recruiting

  • Encore Medical Research of Weston

    Weston, Florida, 33331

    Recruiting

  • KDCILM, LLC & Accellacare US, Inc.

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

Germany8 sites, 8 recruiting

  • Versdias - Diabetologikum Amberg

    Amberg, Bavaria, 92224

    Recruiting

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

    Recruiting

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597

    Recruiting

  • DSP Bochum, Diabetes- und Stoffwechselpraxis

    Bochum, 44869

    Not yet recruiting

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde, 32257

    Not yet recruiting

  • InnoDiab Forschung GmbH

    Essen, 45136

    Recruiting

  • Mesut Durmaz, Hof

    Hof, 95030

    Recruiting

  • CRS Clinical Research Services Mannheim GmbH (hVIVO Mannheim)

    Mannheim, 68167

    Recruiting

Other trials in Germany

Australia6 sites, 6 recruiting

  • Royal Adelaide Hospital - Cardiology Department

    Adelaide, South Australia, 5000

    Recruiting

  • Castle Hill Medical Centre

    Castle Hill, New South Wales, 2154

    Recruiting

  • Novatrials

    Charlestown, New South Wales, 2290

    Recruiting

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

    Recruiting

  • Hunter Medical Research Institute - Endocrinology and Diabetes

    New Lambton Heights, New South Wales, 2305

    Not yet recruiting

  • Roger Chih Yu Chen

    Sydney, New South Wales, 2148

    Recruiting

Other trials in Australia

Poland6 sites, 6 recruiting

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

    Recruiting

  • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar

    Kielce, 25-355

    Recruiting

  • 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Lublin, Lublin Voivodeship, 20-049

    Recruiting

  • Clinical Best Solutions Sp. z o.o., Sp. k

    Lublin, 20-011

    Not yet recruiting

  • Formed 2 Sp. z o.o.

    Oświęcim, 32-600

    Recruiting

Other trials in Poland

Romania6 sites, 6 recruiting

  • Mariodiab Clinic SRL

    Brasov, 500101

    Recruiting

  • SC Nutrilife SRL

    Bucharest, 013764

    Recruiting

  • S.C. Top Diabet Srl

    Craiova, Dolj, 200515

    Recruiting

  • S.C Milena Sante SRL

    Galati, 800001

    Recruiting

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

    Recruiting

  • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

    Timișoara, 300723

    Recruiting

Other trials in Romania

Spain6 sites, 6 recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Eap Osona Sud Alt Congost S.L.P

    Centelles (Barcelona), 08540

    Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006

    Recruiting

  • H. Univ. Marqués de Valdecilla_Endocrinología

    Santander, 39008

    Recruiting

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

    Recruiting

  • Equip D'assistencia Primaria Vic S.L.P.

    Vic, Barcelona, 08500

    Recruiting

Other trials in Spain

Hungary5 sites, 5 recruiting

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1083

    Recruiting

  • PVN Kutató Kft.

    Budapest, 1102

    Recruiting

  • Pécsi Tudományegyetem ÁOK

    Pécs, 7624

    Recruiting

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

    Recruiting

Other trials in Hungary

Slovakia4 sites, 4 recruiting

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

    Recruiting

  • IN-DIA s.r.o.

    Lučenec, 984 01

    Recruiting

  • MEDI-DIA s.r.o.

    Sabinov, 08301

    Recruiting

  • ARETEUS s.r.o.

    Trebišov, 075 01

    Recruiting

Other trials in Slovakia

South Korea4 sites, 4 recruiting

  • Chosun University Hospital_Endocrinology

    Gwangju, 61453

    Not yet recruiting

  • Asan Medical Center_Endocrinology

    Seoul, 05505

    Not yet recruiting

  • The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology

    Seoul, 06591

    Not yet recruiting

  • Korea University Guro Hospital_Endocrinology

    Seoul, 08308

    Not yet recruiting

Other trials in South Korea

About this study

Official title: 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.

Being tested
UBT251, UBT251 Placebo, Semaglutide, Semaglutide Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UBT251Drug

    UBT251 will be administered subcutaneously once-weekly.

  • UBT251 PlaceboDrug

    UBT251 placebo will be administered subcutaneously once-weekly.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously once-weekly.

  • Semaglutide PlaceboDrug

    Semaglutide placebo will be administered subcutaneously once-weekly.

Study groups in NCT07668388
Study groupRoleWhat they receive
UBT251ExperimentalParticipants will receive once weekly UBT251 subcutaneously.
Receives: Drug: UBT251
UBT251 PlaceboPlacebo comparatorParticipants will receive once weekly UBT251 placebo subcutaneously.
Receives: Drug: UBT251 Placebo
SemaglutideActive comparatorParticipants will receive once weekly semaglutide subcutaneously.
Receives: Drug: Semaglutide
Semaglutide PlaceboPlacebo comparatorParticipants will receive once weekly semaglutide placebo subcutaneously.
Receives: Drug: Semaglutide Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UBT251: Change in glycated haemoglobin (HbA1c)

    Measured as percentage (%)-point.

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

Secondary outcomes (24)

  1. UBT251: Relative change in body weight

    Measured as %.

    Measured: From baseline (week 0) to week 40

  2. UBT251: Change in body weight

    Measured as kilogram (kg).

    Measured: From baseline (week 0) to week 40

  3. UBT251 vs placebo: Change in HbA1c

    Measured as %-point.

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

  4. Change in HbA1c

    Measured as %-point.

    Measured: From baseline (week 0) to week 40

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

  7. Change in fasting plasma glucose (FPG)

    Measured as millimoles per litre (mmol/L).

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

  8. CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 milligrams per deciliter (mg/dL))

    Measured as %-points.

    Measured: From baseline (week -2 to week 0) to week 14- 16, week 26-28 and week 38-40, respectively

  9. UBT251 vs placebo: Relative change in body weight

    Measured as %.

    Measured: From baseline (week 0) to week 40

  10. UBT251 vs placebo: Change in body weight

    Measured as kg.

    Measured: From baseline (week 0) to week 40

  11. Change in body mass index (BMI)

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

    Measured: From baseline (week 0) to week 40

  12. Change in waist circumference

    Measured as centimeter (cm).

    Measured: From baseline (week 0) to week 40

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

    Measured: From baseline (week 0) to week 40

  14. Change in systolic blood pressure (SBP)

    Measured as millimetres of mercury (mmHg).

    Measured: From baseline (week 0) to week 40

  15. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to week 40

  16. Change in pulse rate

    Measured in beats/min.

    Measured: From baseline (week 0) to week 40

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

  18. Change in total cholesterol

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

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

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

  21. Change in triglycerides

    Measured as ratio to baseline.

    Measured: From baseline (week 0) to week 40

  22. Change in urine albumin creatinine ratio (UACR)

    Measured as ratio to baseline.

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

  23. 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).

    Measured: From baseline (week 0) to week 40

  24. Number of treatment-emergent adverse events (TEAEs)

    Measured as number of events.

    Measured: From baseline (week 0) to week 46

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start22 Jun 2026
  3. Primary completion4 Oct 2027 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07668388
Sponsor's protocol ID
NN9559-8577
Other IDs
U1111-1329-7014, 2026-525465-42
Status last verified
Oct 2026
First submitted
19 Jun 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing UBT251 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 70 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Germany, Australia, Poland, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07668388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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