RecruitingPhase 1

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

China104 participantsStarted 2025-09-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of Participants with adverse events (AEs)

Timeframe: Part A: Baseline up to Day 15

Number of Participants with adverse events (AEs)

Timeframe: Part B: Baseline up to Day 43

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

Timeframe: Part A: Baseline up to Day 15

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

Timeframe: Part B: Baseline up to Day 43

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Timeframe: Part A: Baseline up to Day 15

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Timeframe: Part B: Baseline up to Day 43

Trial details

NCT IDNCT07160400

SponsorInnovent Biologics Technology Limited (Shanghai R&D Center)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-29

Contact for this trial

Dee Li

18017984650 dee.li@innoventbio.com

View on ClinicalTrials.gov More Part A: Healthy Part B: Overweight or Obesity trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of Participants with adverse events (AEs)

Timeframe: Part A: Baseline up to Day 15

Number of Participants with adverse events (AEs)

Timeframe: Part B: Baseline up to Day 43

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

Timeframe: Part A: Baseline up to Day 15

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

Timeframe: Part B: Baseline up to Day 43

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Timeframe: Part A: Baseline up to Day 15

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Timeframe: Part B: Baseline up to Day 43