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A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After a Single Ascending Dose in Healthy Participants and After Multiple Ascending Doses in Participants With Overweight or Obesity

NCT07160400•Innovent Biologics Technology Limited (Shanghai R&D Center)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 4, 2025

Primary Completion Date

May 29, 2026

Completion Date

September 30, 2026

Last Updated

January 22, 2026

Enrollment

104

ESTIMATED participants

Conditions

Part A: Healthy Part B: Overweight or Obesity

Interventions

Placebo

DRUG

IBI3032 tablets

DRUG

Contacts

Dee Li

CONTACT

18017984650 dee.li@innoventbio.com