Overweight or Obesity
Conditions
Brief summary
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.
Interventions
DRUGIBI362
Administered by subcutaneous injection
DRUGPlacebo
Administered by subcutaneous injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have stable body weight for the past 12 weeks prior to screening 2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening 3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion criteria
1. Have a diagnosis of type 2 diabetes 2. Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening 3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before. 4. Surgical treatment for obesity 5. 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 6. 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 7. Unwilling to comply with smoking and alcohol restrictions during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment adverse events | From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week) | The relationship of each adverse event to the investigational product was assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of Participants With Anti-IBI362 Antibodies | From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week) | 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. |
| 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 | — |
| Evaluate the Glucagon of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week | — |
Countries
China
Outcome results
None listed