A Study of IBI3032 in Chinese Participants With Overweight or Obesity

Not Applicable

Not yet recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: IBI3032; Drug: placebo

• Registration Number: NCT07170319
• Lead Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Brief Summary

This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of IBI3032 in participants with overweight or obesity. It is a multiple ascending dose study in participants with overweight or obesity during the 4-week treatment period.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

Exclusion Criteria

• Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
• Abnormal electrocardiogram (ECG) at screening
• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple ascending dose5 of IBI3032 administered orally.	IBI3032	Cohort 5 IBI3032
Multiple ascending dose5 of placebo administered orally.	placebo	Cohort 5 placebo
Multiple ascending dose1 of placebo administered orally.	placebo	Cohort 1 placebo
Multiple ascending dose4 of placebo administered orally.	placebo	Cohort 4 placebo
Multiple ascending dose3 of IBI3032 administered orally.	IBI3032	Cohort 3 IBI3032
Multiple ascending dose4 of IBI3032 administered orally.	IBI3032	Cohort 4 IBI3032
Multiple ascending dose2 of IBI3032 administered orally.	IBI3032	Cohort 2 IBI3032
Multiple ascending dose3 of placebo administered orally.	placebo	Cohort 3 placebo
Multiple ascending dose2 of placebo administered orally.	placebo	Cohort 2 placebo
Multiple ascending dose1 of IBI3032 administered orally.	IBI3032	Cohort 1 IBI3032

Primary Outcome Measures

Name	Time	Method
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug	Baseline up to Day 43	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	Baseline up to Day 43	A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with adverse events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	Baseline up to Day 43

Secondary Outcome Measures

Name	Time	Method
Under the Serum Concentration-time Curve (AUC) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
maximum concentration (Cmax) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
time to maximum concentration (Tmax) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
clearance (CL) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
apparent volume of distribution (V) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
elimination half-life (T1/2) of IBI3032	Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.	To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

Trial Locations

Locations (1)

The Frist Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China