Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Study Overview
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Brief Summary
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This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.

Official Title
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Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects

Conditions
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Overweight or Obesity

Intervention / Treatment
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* Drug: IBI362
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have stable body weight for the past 12 weeks prior to screening Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff Exclusion Criteria: Have a diagnosis of type 2 diabetes Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before. Surgical treatment for obesity Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study Unwilling to comply with smoking and alcohol restrictions during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI362<br>Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses. | Drug: IBI362<br>* Administered by subcutaneous injection<br>|
| Placebo Comparator: placebo<br>Participants received matching placebo dose regiments by subcutaneous injection | Drug: Placebo<br>* Administered by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment adverse events | The relationship of each adverse event to the investigational product was assessed by the investigator. | From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Anti-IBI362 Antibodies | Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies. | From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week) | 
| Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Evaluate the Glucagon of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Evaluate the Insulin of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Evaluate the C-peptide of IBI362 in overweight or obesity subjects; |  | From the first dose (Day 1 ) of study drug until 12 week | 
| Change in body weight from baseline |  | Baseline (Day 1 ) and 12 week for groups |