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A Study of IBI3032 in Chinese Participants With Overweight or Obesity

NCT ID: NCT07170319

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Multiple ascending dose3 of placebo administered orally.

Cohort 3 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Multiple ascending dose5 of placebo administered orally.

Cohort 5 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Multiple ascending dose1 of IBI3032 administered orally.

Cohort 1 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032. Method of administration: oral, fasted administration.

Multiple ascending dose2 of placebo administered orally.

Cohort 2 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Multiple ascending dose5 of IBI3032 administered orally.

Cohort 5 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032. Method of administration: oral, fasted administration.

Multiple ascending dose1 of placebo administered orally.

Cohort 1 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Multiple ascending dose4 of placebo administered orally.

Cohort 4 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Multiple ascending dose3 of IBI3032 administered orally.

Cohort 3 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032. Method of administration: oral, fasted administration.

Multiple ascending dose4 of IBI3032 administered orally.

Cohort 4 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032. Method of administration: oral, fasted administration.

Multiple ascending dose2 of IBI3032 administered orally.

Cohort 2 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032. Method of administration: oral, fasted administration.

Interventions

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IBI3032

IBI3032. Method of administration: oral, fasted administration.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovent Biologics Technology Limited (Shanghai R&D Center)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Other Identifiers

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CIBI3032T002

Identifier Type: -

Identifier Source: org_study_id