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Active, not recruitingNCT07170319Updated Dec 31, 2025

A Study of IBI3032 in Chinese Participants With Overweight or Obesity

A Phase 1 interventional study of IBI3032 and placebo in Overweight or Obesity, sponsored by Innovent Biologics Technology Limited (Shanghai R&D Center). Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Innovent Biologics Technology Limited (Shanghai R&D Center) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight or Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 79 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Innovent Biologics Technology Limited (Shanghai R&D Center) is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Multiple ascending dose5 of IBI3032 administered orally.

    Cohort 5 IBI3032

    Drug: IBI3032

  • Placebo comparator
    Multiple ascending dose1 of placebo administered orally.

    Cohort 1 placebo

    Drug: placebo

  • Placebo comparator
    Multiple ascending dose4 of placebo administered orally.

    Cohort 4 placebo

    Drug: placebo

  • Experimental
    Multiple ascending dose3 of IBI3032 administered orally.

    Cohort 3 IBI3032

    Drug: IBI3032

  • Experimental
    Multiple ascending dose4 of IBI3032 administered orally.

    Cohort 4 IBI3032

    Drug: IBI3032

  • Experimental
    Multiple ascending dose2 of IBI3032 administered orally.

    Cohort 2 IBI3032

    Drug: IBI3032

  • Placebo comparator
    Multiple ascending dose3 of placebo administered orally.

    Cohort 3 placebo

    Drug: placebo

  • Placebo comparator
    Multiple ascending dose5 of placebo administered orally.

    Cohort 5 placebo

    Drug: placebo

  • Experimental
    Multiple ascending dose1 of IBI3032 administered orally.

    Cohort 1 IBI3032

    Drug: IBI3032

  • Placebo comparator
    Multiple ascending dose2 of placebo administered orally.

    Cohort 2 placebo

    Drug: placebo

Interventions

  • DrugIBI3032

    IBI3032. Method of administration: oral, fasted administration.

  • Drugplacebo

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline up to Day 43

  2. 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

    Time frame: Baseline up to Day 43

  3. Number of Participants with adverse events (AEs)

    Baseline up to Day 43

    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.

Secondary outcomes

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

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

    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.

  2. maximum concentration (Cmax) of IBI3032

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

    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.

  3. time to maximum concentration (Tmax) of IBI3032

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

    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.

  4. clearance (CL) of IBI3032

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

    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.

  5. apparent volume of distribution (V) of IBI3032

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

    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.

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

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

    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.

07

Study locations

1 site
  • The Frist Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07170319
Lead sponsor
Innovent Biologics Technology Limited (Shanghai R&D Center)
Responsible party
Sponsor
First posted
Sep 12, 2025
Start date
Sep 25, 2025
Primary completion
Dec 24, 2025
Completion
Mar 31, 2026 (estimated)
Last update
Dec 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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