This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
Tirzepatide administered subcutaneously (SC) once a week.
Placebo administered subcutaneously (SC) once a week.
IBI362 administered subcutaneously (SC) once a week.
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Incidence of adverse events and serious adverse events during the treatment period
Time frame: week 44
The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: week 44
The incidence rates of Adverse Event of Special Interest
Time frame: week 44
The value of systolic and diastolic pressures
Time frame: week 44
The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram
Time frame: week 44
Any adverse event evaluated by laboratory examinations
Including amylase, lipase, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], calcitonin, urinary albumin-to-creatinine ratio \[UACR\], creatine kinase \[CK\], lactate dehydrogenase \[LDH\], etc
Time frame: week 44
The value of pulse rate
Time frame: week 44
Evaluate the pharmacokinetic (PK) characteristics of IBI362
Maximum Plasma Concentration Area under the concentration-time curve
Time frame: week 44
The change in body weight from baseline
Time frame: week 44
Immunogenicity
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The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab)
Time frame: week 44
The change in waist circumference from baseline
Time frame: week 44
Changes and percentage changes of abdominal visceral fat (VAT) content, abdominal subcutaneous fat (SAT) content, and abdominal total fat (TAAT) content relative to the baseline
Time frame: week 44
Changes and percentage changes of liver fat content compared with the baseline
Time frame: week 44
The changes in insulin resistance index (HOMA2-IR) and islet β-cell function index (HOMA2-B) from baseline calculated by the concentration of fasting blood glucose and the concentration of fasting insulin
Time frame: week 44
The change in body-mass index from baseline
Time frame: week 44
The change in neck circumference from baseline
Time frame: week 44
The change in hip circumference from baseline
Time frame: week 44
The change in waist circumference/hip circumference ratio from baseline
Time frame: week 44
Changes in hemoglobin A1c (HbA1c%) , from baseline
Time frame: week 44
Changes in fasting blood glucose , from baseline
Time frame: week 44
Changes in Fasting insulin, from baseline
Time frame: week 44
Changes in Fasting C-peptide, from baseline
Time frame: week 44