Status:
COMPLETED
A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Overweight/ Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant en...
Eligibility Criteria
Inclusion
- The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²)
- The weight change of the subjects before and after the introduction period was less than 5.0%
Exclusion
- Diabetes mellitus
- Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening
- Have used or are currently using weight loss drugs within 3 months before screening
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of moderate to severe depression，or have a history of serious mental illness
- Any lifetime history of a suicide attempt
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT04904913
Start Date
June 8 2021
End Date
December 6 2023
Last Update
November 17 2025
Active Locations (1)
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1
Peking University people's hospital
Beijing, Beijing Municipality, China, 100044