Part A: Healthy Part B: Overweight or ObesityPhase 1NCT07160400
A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity
A Phase 1 study testing IBI3032 tablets in people with Part A: Healthy Part B: Overweight or Obesity, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Part A: Healthy Part B: Overweight or Obesity
- What is being tested?
- IBI3032 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 10 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200030
About this study
Official 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
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.
- Being tested
- Placebo, IBI3032 tablets
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose placebo IBI3032 administered orally
IBI3032 tabletsDrug
Single dose of IBI3032 administered orally
| Study group | Role | What they receive |
|---|---|---|
| Single dose of IBI3032 administered orally. | Experimental | Part A Receives: Drug: IBI3032 tablets |
| Single dose of placebo administered orally. | Placebo comparator | Part A Receives: Drug: Placebo |
| Multiple doses of IBI3032 administered orally. | Experimental | Part B Receives: Drug: IBI3032 tablets |
| Multiple doses of placebo administered orally. | Placebo comparator | Part B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part B: Baseline up to Day 43
Secondary outcomes (12)
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
clearance (CL) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
clearance (CL) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Part A: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Measured: Part B: Predose up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start4 Sep 2025
- Primary completion6 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Part A: Healthy Part B: Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160400
- Sponsor's protocol ID
- CIBI3032A101
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07160400
- Acronym / sponsor ID
- CIBI3032A101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single dose of IBI3032 administered orally. | Experimental | Drug: IBI3032 tabletsPart A |
| Single dose of placebo administered orally. | Placebo comparator | Drug: PlaceboPart A |
| Multiple doses of IBI3032 administered orally. | Experimental | Drug: IBI3032 tabletsPart B |
| Multiple doses of placebo administered orally. | Placebo comparator | Drug: PlaceboPart B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSingle dose placebo IBI3032 administered orally | Drug | Multiple doses of placebo administered orally., Single dose of placebo administered orally. |
| IBI3032 tabletsSingle dose of IBI3032 administered orally | Drug | Multiple doses of IBI3032 administered orally., Single dose of IBI3032 administered orally. |
Primary outcome
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Under the Serum Concentration-time Curve (AUC) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
Under the Serum Concentration-time Curve (AUC) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
maximum concentration (Cmax) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
time to maximum concentration (Tmax) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
clearance (CL) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
clearance (CL) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
apparent volume of distribution (V) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
Time frame: Part A: Predose up to 168 hours postdose
elimination half-life (T1/2) of IBI3032
Time frame: Part B: Predose up to 168 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI3032 tablets in people with Part A: Healthy Part B: Overweight or Obesity, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse events (AEs) (time frame: Part A: Baseline up to Day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.