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Active, Not Recruiting

NCT Number: NCT07170319

A Study of IBI3032 in Chinese 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 multiple ascending doses of IBI3032 in participants with overweight or obesity. It is a multiple ascending dose study in participants with overweight or obesity during the 4-week treatment period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or females, as determined by medical history
  • Have safety laboratory results within normal reference ranges

Exclusion criteria

  • Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
  • Abnormal electrocardiogram (ECG) at screening
  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Treatment and study plan

IBI3032

Drug

IBI3032. Method of administration: oral, fasted administration.

Placebo

Drug

Placebo (without active ingredients). Method of administration: oral, fasted administration.

Primary outcomes

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

    Time frame: Baseline up to Day 43

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

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

    Time frame: 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

  3. Number of Participants with adverse events (AEs)

    Time frame: 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.

    Baseline up to Day 43

Secondary outcomes

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

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

  2. maximum concentration (Cmax) of IBI3032

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

  3. time to maximum concentration (Tmax) of IBI3032

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

  4. clearance (CL) of IBI3032

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

  5. apparent volume of distribution (V) of IBI3032

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

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

    Time frame: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

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

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 Multiple Ascending Doses in Participants With Overweight or Obesity

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Dec 31, 2025

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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