A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity

Not Applicable

Recruiting

• Conditions: Part A: Healthy Part B: Overweight or Obesity
• Interventions: Drug: IBI3032 tablets; Drug: Placebo

• Registration Number: NCT07160400
• 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 a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-21
• Study Start: 2025-08-27
• Study First Submitted QC: 2025-08-29
• Status Verified: 2025-09
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-10
• Primary Completion: 2025-11-03
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Male or female aged 18-65 years (inclusive) at the time of informed consent.
2. Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.

Exclusion Criteria

1. The investigator suspects that the participant may be allergic to any component of the study drug or GLP-1 receptor agonists, or have used GLP-1 receptor agonists within 3 months prior to screening.
2. History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose < 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.
3. Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single dose of IBI3032 administered orally.	IBI3032 tablets	Part A
Single dose of placebo administered orally.	Placebo	Part A
Multiple doses of IBI3032 administered orally.	IBI3032 tablets	Part B
Multiple doses of placebo administered orally.	Placebo	Part B

Primary Outcome Measures

Name	Time	Method
Number of Participants with adverse events (AEs)	Part B: Baseline up to Day 43	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.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug	Part B: 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	Part B: 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.

Secondary Outcome Measures

Name	Time	Method
Under the Serum Concentration-time Curve (AUC) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
maximum concentration (Cmax) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
time to maximum concentration (Tmax) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
clearance (CL) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
apparent volume of distribution (V) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
elimination half-life (T1/2) of IBI3032	Part B: Predose up to 168 hours postdose	To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.

Trial Locations

Locations (1)

Zhongshan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai Municipality, China