Status:
COMPLETED
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Overweight or Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04440345
Start Date
June 16 2020
End Date
August 6 2021
Last Update
November 28 2023
Active Locations (1)
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1
Peking University people's hospital
Beijing, China