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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
UBT251 will be administered subcutaneously once-weekly.
UBT251 placebo will be administered subcutaneously once-weekly.
Semaglutide will be administered subcutaneously once-weekly.
Semaglutide placebo will be administered subcutaneously once-weekly.
Flourish Research
Birmingham, Alabama, United States
RECRUITINGArk Clinical Research
Fountain Valley, California, United States
RECRUITINGArk Clinical Research
Long Beach, California, United States
RECRUITINGLos Angeles Institute for Metabolic Research
Los Angeles, California, United States
UBT251: Change in glycated haemoglobin (HbA1c)
Measured as percentage (%)-point.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
UBT251: Relative change in body weight
Measured as %.
Time frame: From baseline (week 0) to week 40
UBT251: Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to week 40
UBT251 vs placebo: Change in HbA1c
Measured as %-point.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
Change in HbA1c
Measured as %-point.
Time frame: From baseline (week 0) to week 40
Change in homeostasis model assessment of insulin resistance (HOMA2-IR)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in homeostasis model assessment of beta-cell function (HOMA2-B)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in fasting plasma glucose (FPG)
Measured as millimoles per litre (mmol/L).
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))
Measured as %-points.
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
Measured as %.
Time frame: From baseline (week 0) to week 40
UBT251 vs placebo: Change in body weight
Measured as kg.
Time frame: From baseline (week 0) to week 40
Change in body mass index (BMI)
Measured as Kilograms per square meter (kg/m\^2).
Time frame: From baseline (week 0) to week 40
Change in waist circumference
Measured as centimeter (cm).
Time frame: From baseline (week 0) to week 40
Change in waist-to-height ratio (WHtR)
Time frame: From baseline (week 0) to week 40
Change in systolic blood pressure (SBP)
Measured as millimetres of mercury (mmHg).
Time frame: From baseline (week 0) to week 40
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to week 40
Change in pulse rate
Measured in beats/min.
Time frame: From baseline (week 0) to week 40
Change in high sensitivity C-Reactive Protein (hsCRP)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in total cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in high-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in triglycerides
Measured as ratio to baseline.
Time frame: From baseline (week 0) to week 40
Change in urine albumin creatinine ratio (UACR)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40)
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).
Time frame: From baseline (week 0) to week 40
Number of treatment-emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From baseline (week 0) to week 46
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Catalina Research Institute, LLC
Montclair, California, United States
RECRUITINGEncore Medical Research LLC
Hollywood, Florida, United States
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Miramar, Florida, United States
RECRUITINGEncore Medical Research of Weston
Weston, Florida, United States
RECRUITINGMidwest Inst For Clin Res
Indianapolis, Indiana, United States
NOT_YET_RECRUITINGCotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
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