Clinical trial

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

Name
CIBI362B101
Description
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.
Trial arms
Trial start
2020-06-16
Estimated PCD
2021-06-16
Trial end
2021-08-06
Status
Completed
Phase
Early phase I
Treatment
IBI362
Administered by subcutaneous injection
Arms:
IBI362
Placebo
Administered by subcutaneous injection
Arms:
placebo
Size
60
Primary endpoint
Number of treatment adverse events
From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-11-28

1 organization

2 products

1 indication

Product
Placebo
Indication
Obesity
Product
IBI362