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RecruitingPhase 1NCT07160400

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

Sponsor

Innovent Biologics Technology Limited (Shanghai R&D Center)

Enrollment

104 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Part A: Healthy Part B: Overweight or Obesity

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • Male or female aged 18-65 years (inclusive) at the time of informed consent.
  • 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 Criteria3

  • 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.
  • History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose < 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.
  • Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.

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Interventions

DRUGPlacebo

Single dose placebo IBI3032 administered orally

DRUGIBI3032 tablets

Single dose of IBI3032 administered orally

Locations(1)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

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NCT07160400