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NCT07668388PHASE2Recruiting

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

Novo Nordisk A/S

Start Date

6/22/2026

Completion Date

11/15/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

UBT251

DRUG

UBT251 Placebo

DRUG

Semaglutide

DRUG

Semaglutide Placebo

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Conditions

Diabetes Mellitus, Type 2

Locations

Flourish Research

Birmingham, Alabama 35205

United States

Ark Clinical Research

Fountain Valley, California 92708

United States

Ark Clinical Research

Long Beach, California 90815

United States

Los Angeles Institute for Metabolic Research

Los Angeles, California 90015

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Encore Medical Research LLC

Hollywood, Florida 33021

United States

South Broward Research LLC

Miramar, Florida 33027

United States

Encore Medical Research of Weston

Weston, Florida 33331

United States

Midwest Inst For Clin Res

Indianapolis, Indiana 46260

United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas 66606

United States

MD Medical Research

Oxon Hill, Maryland 20745

United States

PharmQuest

Greensboro, North Carolina 27408

United States

KDCILM, LLC & Accellacare US, Inc.

Wilmington, North Carolina 28401

United States

Plains Clinical Research Center, LLC_Fargo

Fargo, North Dakota 58104

United States

Preferred Primary Care Physicians, Inc.

Uniontown, Pennsylvania 15401

United States

Monroe Biomedical Research, LLC

North Charleston, South Carolina 29406

United States

LifeDoc Health

Memphis, Tennessee 38115

United States

IMA Clinical Research

Austin, Texas 78745

United States

Private Practice - Dr. Laila A. Hassan

Houston, Texas 77089

United States

Radiance Clinical Research

Lampasas, Texas 76550

United States

Quality Research Inc

San Antonio, Texas 78209

United States

Tekton Research Inc

San Antonio, Texas 78258

United States

Consano Clin Res-Shavano Park

Shavano Park, Texas 78231

United States

Chrysalis Clinical Research

St. George, Utah 84790

United States

The Vancouver Clinic

Vancouver, Washington 98664

United States

Castle Hill Medical Centre

Castle Hill, New South Wales 2154

Australia

Hunter Medical Research Institute - Endocrinology and Diabetes

New Lambton Heights, New South Wales 2305

Australia

Roger Chih Yu Chen

Sydney, New South Wales 2148

Australia

Royal Adelaide Hospital - Cardiology Department

Adelaide, South Australia 5000

Australia

Baker Heart and Diabetes Institute

Melbourne, Victoria 3004

Australia

Versdias - Diabetologikum Amberg

Amberg, Bavaria 92224

Germany

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545

Germany

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

Berlin, 13597

Germany

DSP Bochum, Diabetes- und Stoffwechselpraxis

Bochum, 44869

Germany

Studiengesellschaft Dres. Könemann/Steinmann GbR

Bünde, 32257

Germany

InnoDiab Forschung GmbH

Essen, 45136

Germany

Mesut Durmaz, Hof

Hof, 95030

Germany

CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)

Mannheim, 68167

Germany

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád 6725

Hungary

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032

Hungary

Semmelweis Egyetem

Budapest, 1083

Hungary

PVN Kutató Kft.

Budapest, 1102

Hungary

Pécsi Tudományegyetem ÁOK

Pécs, 7624

Hungary

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Lublin, Lublin Voivodeship 20-049

Poland

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship 15-879

Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276

Poland

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

Kielce, 25-355

Poland

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

Lublin, 20-011

Poland

Formed 2 Sp. z o.o.

Oświęcim, 32-600

Poland

S.C. Top Diabet Srl

Craiova, Dolj 200515

Romania

Mariodiab Clinic SRL

Brasov, 500101

Romania

SC Nutrilife SRL

Bucharest, 013764

Romania

S.C Milena Sante SRL

Galati, 800001

Romania

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055

Romania

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, 300723

Romania

MEDISPEKTRUM s.r.o.

Bratislava, 851 01

Slovakia

IN-DIA s.r.o.

Lučenec, 984 01

Slovakia

MEDI-DIA s.r.o.

Sabinov, 08301

Slovakia

ARETEUS s.r.o.

Trebišov, 075 01

Slovakia

Chosun University Hospital_Endocrinology

Gwangju, 61453

South Korea

Asan Medical Center_Endocrinology

Seoul, 05505

South Korea

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

Seoul, 06591

South Korea

Korea University Guro Hospital_Endocrinology

Seoul, 08308

South Korea

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

Vic, Barcelona 08500

Spain

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Eap Osona Sud Alt Congost S.L.P

Centelles (Barcelona), 08540

Spain

Hospital Universitario de la Princesa

Madrid, 28006

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010

Spain