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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 | Experimental | Stage 1: subcutaneous injection, qw; dose ranging from 2.0mg to 15.0mg,44w Stage 2: subcutaneous injection, q2w; 12.0mg or 15.0mg, 12w; |
|
| Placebo | Placebo Comparator | Stage 1: subcutaneous injection, 0mg, qw, 44w Stage 2: subcutaneous injection, dose ranging from 2.0mg to 6.0mg,qw, 12w |
|
| Tirzepatide | Active Comparator | Open label: subcutaneous injection, qw, dose ranging from 2.5mg to 15.0mg, 44w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Tirzepatide administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of adverse events and serious adverse events during the treatment period | week 44 | |
| The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS) | week 44 | |
| The incidence rates of Adverse Event of Special Interest | week 44 | |
| The value of systolic and diastolic pressures | week 44 | |
| The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram | 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 | week 44 |
| The value of pulse rate | week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetic (PK) characteristics of IBI362 | Maximum Plasma Concentration Area under the concentration-time curve | week 44 |
| The change in body weight from baseline | week 44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210003 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| C000719829 | mazdutide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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blinded: participant, investigator, outcome assessor
| Placebo |
| Drug |
Placebo administered subcutaneously (SC) once a week. |
|
| IBI362 | Drug | IBI362 administered subcutaneously (SC) once a week. |
|
| Immunogenicity | The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab) | week 44 |
| The change in waist circumference from baseline | 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 | week 44 |
| Changes and percentage changes of liver fat content compared with the baseline | 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 | week 44 |
| The change in body-mass index from baseline | week 44 |
| The change in neck circumference from baseline | week 44 |
| The change in hip circumference from baseline | week 44 |
| The change in waist circumference/hip circumference ratio from baseline | week 44 |
| Changes in hemoglobin A1c (HbA1c%) , from baseline | week 44 |
| Changes in fasting blood glucose , from baseline | week 44 |
| Changes in Fasting insulin, from baseline | week 44 |
| Changes in Fasting C-peptide, from baseline | week 44 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |