Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg Administered Multiple Times in Chinese Patients With Moderate to Severe Obesity

Registration

Registration

NCT07000955

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1; PHASE2

Masking

TRIPLE

Status

ACTIVE_NOT_RECRUITING

Enrollment

98

Start

2025-06-17

Primary completion

2026-09-30

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Conditions

Obesity

Interventions

DRUG:Tirzepatide; DRUG:Placebo; DRUG:IBI362

Results posted

FALSE

Registered primary outcomes

• The Incidence of adverse events and serious adverse events during the treatment period [week 44]
• The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS) [week 44]
• The incidence rates of Adverse Event of Special Interest [week 44]
• The value of systolic and diastolic pressures [week 44]
• The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram [week 44]
• Any adverse event evaluated by laboratory examinations [week 44]
• The value of pulse rate [week 44]