Obesity
Conditions
Brief summary
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
Interventions
DRUGTirzepatide
Tirzepatide administered subcutaneously (SC) once a week.
DRUGPlacebo
Placebo administered subcutaneously (SC) once a week.
DRUGIBI362
IBI362 administered subcutaneously (SC) once a week.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
blinded: participant, investigator, outcome assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 1\. The age at the time of screening is 18 to 55 years old (including both ends), male or female; * 2\. BMI≥32.5 kg/m2 during screening; * 3\. At the time of screening, after simple diet and exercise control for at least 12 weeks, the weight change was less than 5% \[(Maximum weight within 3 months before screening - minimum weight within 3 months before screening)/maximum weight within 3 months before screening ×100%, self-reported by the subjects\] * 4\. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and within 3 months after the last treatment. Female subjects with reproductive capacity must have negative pregnancy test results during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment; * 5\. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions in the informed consent form and protocol throughout the research period, including but not limited to: diet, exercise, lifestyle management, planned injection of research drugs, keeping research diaries, and completing relevant questionnaires, etc;
Exclusion criteria
* 1\. The investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution; * 2\. Use any of the following drugs or treatments within 3 months before screening including but not limited to GLP-1R, GIPR, GCGR, any drugs, Chinese herbal medicines, health supplements or meal replacements that have an impact on body weight, or participated in other clinical trials; * 3\. There is a history or evidence of any of the following diseases before screening or at the time of screening including but not limited to diabetes, have received or plan to undergo bariatric surgery during the research period in the past, with retinopathy in the past or at the time of screening, secondary diseases or drugs lead to obesity, have a history of depression in the past or have a history of serious mental illness in the past, hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment, a history of malignant tumors was present during the screening, heart disease, A 2A or 2B history or family history of medullary thyroid carcinoma and multiple endocrine adenomatosis (MEN) , history of acute and chronic pancreatitis, limb deformity or disability, have a history of suicidal tendencies or suicidal behaviors, etc according to the protocol. * 4\. Any of the laboratory examination indicators meets the following standards during screening: serum calcitonin ≥20ng/L during screening, alanine aminotransferase ≥2.0×ULN and/or aspartate aminotransferase ≥2.0×ULN and/or total bilirubin ≥1.5×ULN and/or alkaline phosphatase ≥2.0×ULN, eGFR is less than 60 Ml/min/1.73 m2, abnormal thyroid function including FT3, FT4, or TSH, fasting triglycerides ≥5.64 mmol/L (500 mg/dl), blood amylase or lipase 1.0 x ULN; * 5\. During the screening, the 12-lead electrocardiogram showed a heart rate of \<50 beats per minute or \>90 beats per minute; * 6\. There were clinically significant ECGs abnormalities during the screening; * 7\. History of other risk factors for tachycardia; * 8\. The blood donation volume and/or blood loss volume within 3 months prior to screening is ≥400mL, or bone marrow donation has been performed, or there are anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, etc., or hemoglobin.. 110g/ L (male) or 100g/L (females). * 9\. The investigators believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study and are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | week 44 | Including amylase, lipase, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], calcitonin, urinary albumin-to-creatinine ratio \[UACR\], creatine kinase \[CK\], lactate dehydrogenase \[LDH\], etc |
| The value of pulse rate | week 44 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Evaluate the pharmacokinetic (PK) characteristics of IBI362 | week 44 | Maximum Plasma Concentration Area under the concentration-time curve |
| 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 | — |
| Changes in hemoglobin A1c (HbA1c%) , from baseline | week 44 | — |
| The change in body weight from baseline | week 44 | — |
| Immunogenicity | week 44 | The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab) |
| 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 | — |
Countries
China
Outcome results
None listed