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

NCT07160400 | Recruiting Phase 1

• 1 other identifier: CIBI3032A101
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Part A: Healthy Part B: Overweight or Obesity

Outcome Measures

Primary Outcomes (6)

• Number of Participants with adverse events (AEs)

  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.

  Part A: Baseline up to Day 15

• Number of Participants with adverse events (AEs)

  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.

  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

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

  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

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

  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

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

  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

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

  Part B: Baseline up to Day 43

Secondary Outcomes (12)

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

  Part A: Predose up to 168 hours postdose

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

  Part B: Predose up to 168 hours postdose

• maximum concentration (Cmax) of IBI3032

  Part A: Predose up to 168 hours postdose

• maximum concentration (Cmax) of IBI3032

  Part B: Predose up to 168 hours postdose

• time to maximum concentration (Tmax) of IBI3032

  Part A: Predose up to 168 hours postdose

Study Arms (4)

Single dose of IBI3032 administered orally.

EXPERIMENTAL

Part A

Drug: IBI3032 tablets

Single dose of placebo administered orally.

PLACEBO COMPARATOR

Part A

Drug: Placebo

Multiple doses of IBI3032 administered orally.

EXPERIMENTAL

Part B

Drug: IBI3032 tablets

Multiple doses of placebo administered orally.

PLACEBO COMPARATOR

Part B

Drug: Placebo

Interventions

Placebo DRUG

Single dose placebo IBI3032 administered orally

Multiple doses of placebo administered orally.; Single dose of placebo administered orally.

IBI3032 tablets DRUG

Single dose of IBI3032 administered orally

Multiple doses of IBI3032 administered orally.; Single dose of IBI3032 administered orally.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dee Li

CONTACT

18017984650; dee.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)