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

NCT07668388 · Novo Nordisk A/S
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Official title
Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study
About this 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.
Eligibility criteria
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 design
Enrollment target: 300 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-06-22
Estimated completion: 2027-11-15
Last updated: 2026-07-14
Interventions
Drug: UBT251Drug: UBT251 PlaceboDrug: SemaglutideDrug: Semaglutide Placebo
Primary outcomes
  • UBT251: Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40))
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency dept. 2834 · study_director, Novo Nordisk A/S
All locations (69)
Flourish ResearchRecruiting
Birmingham, Alabama, United States
Ark Clinical ResearchRecruiting
Fountain Valley, California, United States
Ark Clinical ResearchRecruiting
Long Beach, California, United States
Los Angeles Institute for Metabolic ResearchRecruiting
Los Angeles, California, United States
Catalina Research Institute, LLCRecruiting
Montclair, California, United States
Encore Medical Research LLCRecruiting
Hollywood, Florida, United States
South Broward Research LLCRecruiting
Miramar, Florida, United States
Encore Medical Research of WestonRecruiting
Weston, Florida, United States
Midwest Inst For Clin ResNot Yet Recruiting
Indianapolis, Indiana, United States
Cotton O'Neil Diabetes & EndocrinologyRecruiting
Topeka, Kansas, United States
MD Medical ResearchRecruiting
Oxon Hill, Maryland, United States
PharmQuestNot Yet Recruiting
Greensboro, North Carolina, United States
KDCILM, LLC & Accellacare US, Inc.Recruiting
Wilmington, North Carolina, United States
Plains Clinical Research Center, LLC_FargoNot Yet Recruiting
Fargo, North Dakota, United States
Preferred Primary Care Physicians, Inc.Recruiting
Uniontown, Pennsylvania, United States
Monroe Biomedical Research, LLCRecruiting
North Charleston, South Carolina, United States
LifeDoc HealthRecruiting
Memphis, Tennessee, United States
IMA Clinical ResearchRecruiting
Austin, Texas, United States
Private Practice - Dr. Laila A. HassanRecruiting
Houston, Texas, United States
Radiance Clinical ResearchRecruiting
Lampasas, Texas, United States
Quality Research IncRecruiting
San Antonio, Texas, United States
Tekton Research IncRecruiting
San Antonio, Texas, United States
Consano Clin Res-Shavano ParkRecruiting
Shavano Park, Texas, United States
Chrysalis Clinical ResearchRecruiting
St. George, Utah, United States
The Vancouver ClinicNot Yet Recruiting
Vancouver, Washington, United States
Castle Hill Medical CentreNot Yet Recruiting
Castle Hill, New South Wales, Australia
Hunter Medical Research Institute - Endocrinology and DiabetesNot Yet Recruiting
New Lambton Heights, New South Wales, Australia
Roger Chih Yu ChenNot Yet Recruiting
Sydney, New South Wales, Australia
Royal Adelaide Hospital - Cardiology DepartmentNot Yet Recruiting
Adelaide, South Australia, Australia
Baker Heart and Diabetes InstituteNot Yet Recruiting
Melbourne, Victoria, Australia
Versdias - Diabetologikum AmbergNot Yet Recruiting
Amberg, Bavaria, Germany
Herz- und Diabeteszentrum NRW - Bad OeynhausenNot Yet Recruiting
Bad Oeynhausen, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbRNot Yet Recruiting
Berlin, Germany
DSP Bochum, Diabetes- und StoffwechselpraxisNot Yet Recruiting
Bochum, Germany
Studiengesellschaft Dres. Könemann/Steinmann GbRNot Yet Recruiting
Bünde, Germany
InnoDiab Forschung GmbHNot Yet Recruiting
Essen, Germany
Mesut Durmaz, HofNot Yet Recruiting
Hof, Germany
CRS Clinical Research Mannheim GmbH (hVIVO Mannheim)Not Yet Recruiting
Mannheim, Germany
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai KözpontNot Yet Recruiting
Szeged, Csongrád-Csanád, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.Not Yet Recruiting
Budapest, Hungary
Semmelweis EgyetemNot Yet Recruiting
Budapest, Hungary
PVN Kutató Kft.Not Yet Recruiting
Budapest, Hungary
Pécsi Tudományegyetem ÁOKNot Yet Recruiting
Pécs, Hungary
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZNot Yet Recruiting
Lublin, Lublin Voivodeship, Poland
NZOZ Vita-Diabetica Malgorzata BuraczykNot Yet Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w BialymstokuNot Yet Recruiting
Bialystok, Poland
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika PiwowarNot Yet Recruiting
Kielce, Poland
Clinical Best Solutions Sp. z o.o., Sp. kNot Yet Recruiting
Lublin, Poland
Formed 2 Sp. z o.o.Not Yet Recruiting
Oświęcim, Poland
S.C. Top Diabet SrlNot Yet Recruiting
Craiova, Dolj, Romania
Mariodiab Clinic SRLNot Yet Recruiting
Brasov, Romania
SC Nutrilife SRLNot Yet Recruiting
Bucharest, Romania
S.C Milena Sante SRLNot Yet Recruiting
Galati, Romania
Clinica Korall S.R.L. Satu MareNot Yet Recruiting
Satu Mare, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraNot Yet Recruiting
Timișoara, Romania
MEDISPEKTRUM s.r.o.Not Yet Recruiting
Bratislava, Slovakia
IN-DIA s.r.o.Not Yet Recruiting
Lučenec, Slovakia
MEDI-DIA s.r.o.Not Yet Recruiting
Sabinov, Slovakia
ARETEUS s.r.o.Not Yet Recruiting
Trebišov, Slovakia
Chosun University Hospital_EndocrinologyNot Yet Recruiting
Gwangju, South Korea
Asan Medical Center_EndocrinologyNot Yet Recruiting
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital_EndocrinologyNot Yet Recruiting
Seoul, South Korea
Korea University Guro Hospital_EndocrinologyNot Yet Recruiting
Seoul, South Korea
Equip D'assistencia Primaria Vic S.L.P.Not Yet Recruiting
Vic, Barcelona, Spain
Hospital Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Eap Osona Sud Alt Congost S.L.PNot Yet Recruiting
Centelles (Barcelona), Spain
Hospital Universitario de la PrincesaNot Yet Recruiting
Madrid, Spain
Hospital Universitario Marqués de ValdecillaNot Yet Recruiting
Santander, Spain
H. Infanta Luisa_Endocrino y ObesidadNot Yet Recruiting
Seville, Spain
A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes · TrialPath