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

NCT07668388 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: NN9559-8577U1111-1329-70142026-525465-42
• Study Type: interventional
• Target: 300
• Locations: 9 countries
• Sites: 70

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• UBT251: Change in glycated haemoglobin (HbA1c)

  Measured as percentage (%)-point.

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

Secondary Outcomes (24)

• UBT251: Relative change in body weight

  From baseline (week 0) to week 40

• UBT251: Change in body weight

  From baseline (week 0) to week 40

• UBT251 vs placebo: Change in HbA1c

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

• Change in HbA1c

  From baseline (week 0) to week 40

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

  From baseline (week 0) to week 40

Study Arms (4)

UBT251

EXPERIMENTAL

Participants will receive once weekly UBT251 subcutaneously.

Drug: UBT251

UBT251 Placebo

PLACEBO COMPARATOR

Participants will receive once weekly UBT251 placebo subcutaneously.

Drug: UBT251 Placebo

Semaglutide

ACTIVE COMPARATOR

Participants will receive once weekly semaglutide subcutaneously.

Drug: Semaglutide

Semaglutide Placebo

PLACEBO COMPARATOR

Participants will receive once weekly semaglutide placebo subcutaneously.

Drug: Semaglutide Placebo

Interventions

UBT251 DRUG

UBT251 will be administered subcutaneously once-weekly.

UBT251

Semaglutide DRUG

Semaglutide will be administered subcutaneously once-weekly.

Semaglutide

UBT251 Placebo DRUG

UBT251 placebo will be administered subcutaneously once-weekly.

UBT251 Placebo

Semaglutide Placebo DRUG

Semaglutide placebo will be administered subcutaneously once-weekly.

Semaglutide Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (70)

Flourish Research

Birmingham, Alabama, 35205, United States

RECRUITING

Ark Clinical Research

Fountain Valley, California, 92708, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Los Angeles Institute for Metabolic Research

Los Angeles, California, 90015, United States

RECRUITING

Catalina Research Institute, LLC

Montclair, California, 91763, United States

RECRUITING

Encore Medical Research LLC

Hollywood, Florida, 33024, United States

RECRUITING

South Broward Research LLC

Miramar, Florida, 33027, United States

RECRUITING

Encore Medical Research of Weston

Weston, Florida, 33331, United States

RECRUITING

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

NOT YET RECRUITING

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

RECRUITING

MD Medical Research

Oxon Hill, Maryland, 20745, United States

RECRUITING

PharmQuest

Greensboro, North Carolina, 27408, United States

NOT YET RECRUITING

KDCILM, LLC & Accellacare US, Inc.

Wilmington, North Carolina, 28401, United States

RECRUITING

Plains Clinical Research Center, LLC_Fargo

Fargo, North Dakota, 58104, United States

NOT YET RECRUITING

Preferred Primary Care Physicians, Inc.

Uniontown, Pennsylvania, 15401, United States

RECRUITING

Monroe Biomedical Research, LLC

North Charleston, South Carolina, 29406, United States

RECRUITING

LifeDoc Health

Memphis, Tennessee, 38115, United States

RECRUITING

IMA Clinical Research

Austin, Texas, 78745, United States

RECRUITING

Private Practice - Dr. Laila A. Hassan

Houston, Texas, 77089, United States

RECRUITING

Radiance Clinical Research

Lampasas, Texas, 76550, United States

RECRUITING

Quality Research Inc

San Antonio, Texas, 78209, United States

RECRUITING

Tekton Research Inc

San Antonio, Texas, 78258, United States

RECRUITING

Consano Clin Res-Shavano Park

Shavano Park, Texas, 78231, United States

RECRUITING

Chrysalis Clinical Research

St. George, Utah, 84790, United States

RECRUITING

The Vancouver Clinic

Vancouver, Washington, 98664, United States

NOT YET RECRUITING

Castle Hill Medical Centre

Castle Hill, New South Wales, 2154, Australia

RECRUITING

Novatrials

Charlestown, New South Wales, 2290, Australia

NOT YET RECRUITING

Hunter Medical Research Institute - Endocrinology and Diabetes

New Lambton Heights, New South Wales, 2305, Australia

NOT YET RECRUITING

Roger Chih Yu Chen

Sydney, New South Wales, 2148, Australia

RECRUITING

Royal Adelaide Hospital - Cardiology Department

Adelaide, South Australia, 5000, Australia

RECRUITING

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

Versdias - Diabetologikum Amberg

Amberg, Bavaria, 92224, Germany

RECRUITING

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

RECRUITING

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

Berlin, 13597, Germany

RECRUITING

DSP Bochum, Diabetes- und Stoffwechselpraxis

Bochum, 44869, Germany

NOT YET RECRUITING

Studiengesellschaft Dres. Könemann/Steinmann GbR

Bünde, 32257, Germany

NOT YET RECRUITING

InnoDiab Forschung GmbH

Essen, 45136, Germany

RECRUITING

Mesut Durmaz, Hof

Hof, 95030, Germany

RECRUITING

CRS Clinical Research Services Mannheim GmbH (hVIVO Mannheim)

Mannheim, 68167, Germany

RECRUITING

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary

RECRUITING

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

RECRUITING

Semmelweis Egyetem

Budapest, 1083, Hungary

NOT YET RECRUITING

PVN Kutató Kft.

Budapest, 1102, Hungary

RECRUITING

Pécsi Tudományegyetem ÁOK

Pécs, 7624, Hungary

NOT YET RECRUITING

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Lublin, Lublin Voivodeship, 20-049, Poland

NOT YET RECRUITING

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

RECRUITING

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

Kielce, 25-355, Poland

RECRUITING

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

Lublin, 20-011, Poland

NOT YET RECRUITING

Formed 2 Sp. z o.o.

Oświęcim, 32-600, Poland

RECRUITING

S.C. Top Diabet Srl

Craiova, Dolj, 200515, Romania

RECRUITING

Mariodiab Clinic SRL

Brasov, 500101, Romania

RECRUITING

SC Nutrilife SRL

Bucharest, 013764, Romania

RECRUITING

S.C Milena Sante SRL

Galati, 800001, Romania

RECRUITING

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania

RECRUITING

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, 300723, Romania

RECRUITING

MEDISPEKTRUM s.r.o.

Bratislava, 851 01, Slovakia

RECRUITING

IN-DIA s.r.o.

Lučenec, 984 01, Slovakia

RECRUITING

MEDI-DIA s.r.o.

Sabinov, 08301, Slovakia

RECRUITING

ARETEUS s.r.o.

Trebišov, 075 01, Slovakia

RECRUITING

Chosun University Hospital_Endocrinology

Gwangju, 61453, South Korea

NOT YET RECRUITING

Asan Medical Center_Endocrinology

Seoul, 05505, South Korea

NOT YET RECRUITING

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

Seoul, 06591, South Korea

NOT YET RECRUITING

Korea University Guro Hospital_Endocrinology

Seoul, 08308, South Korea

NOT YET RECRUITING

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

Vic, Barcelona, 08500, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Eap Osona Sud Alt Congost S.L.P

Centelles (Barcelona), 08540, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, 28006, Spain

RECRUITING

H. Univ. Marqués de Valdecilla_Endocrinología

Santander, 39008, Spain

NOT YET RECRUITING

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): October 4, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

HU (5); US (25); AU (6); RO (6); DE (8); SL (4); KR (4); PL (6); ES (6)