This randomized, double-blind, parallel, placebo-controlled phase II study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
205
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Body Weight
Percentage change in body weight from baseline after 24 weeks of treatment
Time frame: Week 24
Waist Circumference
change in waist circumference from baseline after 24 weeks of treatment
Time frame: Week 24
BMI
change in BMI from baseline after 24 weeks of treatment
Time frame: Week 24
Fasting Serum Lipids
change in fasting serum lipids from baseline after 24 weeks of treatment
Time frame: Week 24
Systolic blood pressure
change in systolic blood pressure from baseline after 24 weeks of treatment
Time frame: Week 24
Diastolic blood pressure
change in diastolic blood pressure from baseline after 24 weeks of treatment
Time frame: Week 24
HbA1c
change in HbA1c from baseline after 24 weeks of treatment
Time frame: Week 24
Adverse Events
The incidence of Adverse Event (AE), Adverse Event of Special Interest (AESI), Adverse Drug Reaction (ADR), Serious Adverse Event (SAE) and withdrawal due to Adverse Events
Time frame: Through study completion, an average of six months
Mental Health Status
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UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
Changes in mental health status which will be evaluated using the PHQ-9 scale
Time frame: Through study completion, an average of six months
Plasma Concentration
Plasma Concentration of UBT251 at different time point
Time frame: Through study completion, an average of six months
Serum Anti-UBT251 Antibody Incidence
Change in serum anti-UBT251 antibody incidence
Time frame: Through study completion, an average of six months
Titre and neutralizing antibody testing of antibody-positive samples
change in titre and neutralizing antibody testing of antibody-positive samples
Time frame: Through study completion, an average of six months
ECG
change in components of the ECG (e.g. QRS Complex, QT Interval, etc.)
Time frame: Through study completion, an average of six months
Respiration in breaths per minute by investigator
change in respiration in breaths per minute by investigator
Time frame: Through study completion, an average of six months
Temperature in degree Celsius by thermometer
change in temperature in degree Celsius by thermometer
Time frame: Through study completion, an average of six months
Pulse in beats per minute by investigator
change in pulse in beats per minute as measured by the investigator
Time frame: Through study completion, an average of six months
Abnormal findings in physical examination by investigator
change in physical examination by investigator which includes the skin, lymph nodes, head, neck, heart, lungs, abdomen, umbilical region, and spine/limbs. Abnormal findings from the physical examination will be recorded.
Time frame: Through study completion, an average of six months