Active Not Recruiting
PHASE1, PHASE2
INTERVENTIONAL
NCT07000955
Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study
Interventions
Name:
Tirzepatide
Type:
DRUG
Description:
Tirzepatide administered subcutaneously (SC) once a week.
Name:
Placebo
Type:
DRUG
Description:
Placebo administered subcutaneously (SC) once a week.
Name:
IBI362
Type:
DRUG
Description:
IBI362 administered subcutaneously (SC) once a week.
Primary Outcomes
Measure:
The Incidence of adverse events and serious adverse events during the treatment period
TimeFrame:
week 44
Description:
Measure:
The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)
TimeFrame:
week 44
Description:
Measure:
The incidence rates of Adverse Event of Special Interest
TimeFrame:
week 44
Description:
Measure:
The value of systolic and diastolic pressures
TimeFrame:
week 44
Description:
Measure:
The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram
TimeFrame:
week 44
Description:
Measure:
Any adverse event evaluated by laboratory examinations
TimeFrame:
week 44
Description:
Including amylase, lipase, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], calcitonin, urinary albumin-to-creatinine ratio \[UACR\], creatine kinase \[CK\], lactate dehydrogenase \[LDH\], etc
Measure:
The value of pulse rate
TimeFrame:
week 44
Description:
Trial Information
NCT ID
NCT07000955
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE1, PHASE2
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Last Updated
December 15, 2025