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

Official title

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

Overview

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.

Interventions

• Drug UBT251
  UBT251 will be administered subcutaneously once-weekly.
• Drug UBT251 Placebo
  UBT251 placebo will be administered subcutaneously once-weekly.
• Drug Semaglutide
  Semaglutide will be administered subcutaneously once-weekly.
• Drug Semaglutide Placebo
  Semaglutide placebo will be administered subcutaneously once-weekly.

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• UBT251: Relative change in body weight [Time frame: From baseline (week 0) to week 40]
• UBT251: Change in body weight [Time frame: 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)]
• Change in HbA1c [Time frame: 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]
• Change in homeostasis model assessment of beta-cell function (HOMA2-B) [Time frame: 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)]
• 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]
• UBT251 vs placebo: Relative change in body weight [Time frame: From baseline (week 0) to week 40]
• UBT251 vs placebo: Change in body weight [Time frame: From baseline (week 0) to week 40]
• Change in body mass index (BMI) [Time frame: From baseline (week 0) to week 40]
• Change in waist circumference [Time frame: From baseline (week 0) to week 40]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 25 centers

• Flourish Research — Birmingham
• Ark Clinical Research — Fountain Valley
• Ark Clinical Research — Long Beach
• Los Angeles Institute for Metabolic Research — Los Angeles
• Catalina Research Institute, LLC — Montclair
• Encore Medical Research LLC — Hollywood
• South Broward Research LLC — Miramar
• Encore Medical Research of Weston — Weston
• … and 17 more centers

Germany · 8 centers

• Versdias - Diabetologikum Amberg — Amberg
• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen
• Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR — Berlin
• DSP Bochum, Diabetes- und Stoffwechselpraxis — Bochum
• Studiengesellschaft Dres. Könemann/Steinmann GbR — Bünde
• InnoDiab Forschung GmbH — Essen
• Mesut Durmaz, Hof — Hof
• CRS Clinical Research Mannheim GmbH (hVIVO Mannheim) — Mannheim

Poland · 6 centers

• 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ — Lublin
• NZOZ Vita-Diabetica Malgorzata Buraczyk — Bialystok
• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok
• Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika P — Kielce
• Clinical Best Solutions Sp. z o.o., Sp. k — Lublin
• Formed 2 Sp. z o.o. — Oświęcim

Romania · 6 centers

• S.C. Top Diabet Srl — Craiova
• Mariodiab Clinic SRL — Brasov
• SC Nutrilife SRL — Bucharest
• S.C Milena Sante SRL — Galati
• Clinica Korall S.R.L. Satu Mare — Satu Mare
• Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara — Timișoara

Spain · 6 centers

• Equip D'assistencia Primaria Vic S.L.P. — Vic
• Hospital Vall d'Hebron — Barcelona
• Eap Osona Sud Alt Congost S.L.P — Centelles (Barcelona)
• Hospital Universitario de la Princesa — Madrid
• Hospital Universitario Marqués de Valdecilla — Santander
• H. Infanta Luisa_Endocrino y Obesidad — Seville

Australia · 5 centers

• Castle Hill Medical Centre — Castle Hill
• Hunter Medical Research Institute - Endocrinology and Diabetes — New Lambton Heights
• Roger Chih Yu Chen — Sydney
• Royal Adelaide Hospital - Cardiology Department — Adelaide
• Baker Heart and Diabetes Institute — Melbourne

Hungary · 5 centers

• Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged
• Szent Margit Rendelőintézet Nonprofit Kft. — Budapest
• Semmelweis Egyetem — Budapest
• PVN Kutató Kft. — Budapest
• Pécsi Tudományegyetem ÁOK — Pécs

Slovakia · 4 centers

• MEDISPEKTRUM s.r.o. — Bratislava
• IN-DIA s.r.o. — Lučenec
• MEDI-DIA s.r.o. — Sabinov
• ARETEUS s.r.o. — Trebišov

South Korea · 4 centers

• Chosun University Hospital_Endocrinology — Gwangju
• Asan Medical Center_Endocrinology — Seoul
• The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology — Seoul
• Korea University Guro Hospital_Endocrinology — Seoul

Identifiers

NCT: NCT07668388 · NN9559-8577 · U1111-1329-7014 · 2026-525465-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗