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Completed

NCT Number: NCT07160400

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

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.

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Key information

Conditions

Part A: Healthy Part B: Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Single dose placebo IBI3032 administered orally

IBI3032 tablets

Drug

Single dose of IBI3032 administered orally

Primary outcomes

  1. Number of Participants with adverse events (AEs)

    Time frame: Part A: Baseline up to Day 15

    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.

  2. Number of Participants with adverse events (AEs)

    Time frame: 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.

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

    Time frame: Part A: Baseline up to Day 15

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.

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

    Time frame: Part B: Baseline up to Day 43

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.

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

    Time frame: Part A: Baseline up to Day 15

    A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

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

    Time frame: 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 outcomes

  1. Under the Serum Concentration-time Curve (AUC) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  2. Under the Serum Concentration-time Curve (AUC) of IBI3032

    Time frame: 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.

  3. maximum concentration (Cmax) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  4. maximum concentration (Cmax) of IBI3032

    Time frame: 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.

  5. time to maximum concentration (Tmax) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  6. time to maximum concentration (Tmax) of IBI3032

    Time frame: 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.

  7. clearance (CL) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  8. clearance (CL) of IBI3032

    Time frame: 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.

  9. apparent volume of distribution (V) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  10. apparent volume of distribution (V) of IBI3032

    Time frame: 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.

  11. elimination half-life (T1/2) of IBI3032

    Time frame: Part A: Predose up to 168 hours postdose

    To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

  12. elimination half-life (T1/2) of IBI3032

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Innovent Biologics Technology Limited (Shanghai R&D Center)

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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