Overweight or ObesityPhase 1NCT07170319
A Study of IBI3032 in Chinese Participants With Overweight or Obesity
A Phase 1 study testing IBI3032 in people with 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 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
- Overweight or Obesity
- What is being tested?
- IBI3032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 31 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Frist Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official 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
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.
- Conditions
- Overweight or Obesity
- Being tested
- IBI3032, placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3032Drug
IBI3032. Method of administration: oral, fasted administration.
placeboDrug
Placebo (without active ingredients). Method of administration: oral, fasted administration.
| Study group | Role | What they receive |
|---|---|---|
| Multiple ascending dose5 of IBI3032 administered orally. | Experimental | Cohort 5 IBI3032 Receives: Drug: IBI3032 |
| Multiple ascending dose1 of placebo administered orally. | Placebo comparator | Cohort 1 placebo Receives: Drug: placebo |
| Multiple ascending dose4 of placebo administered orally. | Placebo comparator | Cohort 4 placebo Receives: Drug: placebo |
| Multiple ascending dose3 of IBI3032 administered orally. | Experimental | Cohort 3 IBI3032 Receives: Drug: IBI3032 |
| Multiple ascending dose4 of IBI3032 administered orally. | Experimental | Cohort 4 IBI3032 Receives: Drug: IBI3032 |
| Multiple ascending dose2 of IBI3032 administered orally. | Experimental | Cohort 2 IBI3032 Receives: Drug: IBI3032 |
| Multiple ascending dose3 of placebo administered orally. | Placebo comparator | Cohort 3 placebo Receives: Drug: placebo |
| Multiple ascending dose5 of placebo administered orally. | Placebo comparator | Cohort 5 placebo Receives: Drug: placebo |
| Multiple ascending dose1 of IBI3032 administered orally. | Experimental | Cohort 1 IBI3032 Receives: Drug: IBI3032 |
| Multiple ascending dose2 of placebo administered orally. | Placebo comparator | Cohort 2 placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Baseline up to Day 43
Number of Participants with adverse events (AEs)
Baseline up to Day 43
Measured: 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 (6)
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: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 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: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.
clearance (CL) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Measured: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 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: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 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: Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start25 Sep 2025
- Primary completion24 Dec 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 79 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
- NCT07170319
- Sponsor's protocol ID
- CIBI3032T002
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2025
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. 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 Multiple Ascending Doses in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07170319
- Acronym / sponsor ID
- CIBI3032T002
- Conditions
- Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Multiple ascending dose5 of IBI3032 administered orally. | Experimental | Drug: IBI3032Cohort 5 IBI3032 |
| Multiple ascending dose1 of placebo administered orally. | Placebo comparator | Drug: placeboCohort 1 placebo |
| Multiple ascending dose4 of placebo administered orally. | Placebo comparator | Drug: placeboCohort 4 placebo |
| Multiple ascending dose3 of IBI3032 administered orally. | Experimental | Drug: IBI3032Cohort 3 IBI3032 |
| Multiple ascending dose4 of IBI3032 administered orally. | Experimental | Drug: IBI3032Cohort 4 IBI3032 |
| Multiple ascending dose2 of IBI3032 administered orally. | Experimental | Drug: IBI3032Cohort 2 IBI3032 |
| Multiple ascending dose3 of placebo administered orally. | Placebo comparator | Drug: placeboCohort 3 placebo |
| Multiple ascending dose5 of placebo administered orally. | Placebo comparator | Drug: placeboCohort 5 placebo |
| Multiple ascending dose1 of IBI3032 administered orally. | Experimental | Drug: IBI3032Cohort 1 IBI3032 |
| Multiple ascending dose2 of placebo administered orally. | Placebo comparator | Drug: placeboCohort 2 placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| IBI3032IBI3032. Method of administration: oral, fasted administration. | Drug | Multiple ascending dose1 of IBI3032 administered orally., Multiple ascending dose2 of IBI3032 administered orally., Multiple ascending dose3 of IBI3032 administered orally., Multiple ascending dose4 of IBI3032 administered orally., Multiple ascending dose5 of IBI3032 administered orally. |
| placeboPlacebo (without active ingredients). Method of administration: oral, fasted administration. | Drug | Multiple ascending dose1 of placebo administered orally., Multiple ascending dose2 of placebo administered orally., Multiple ascending dose3 of placebo administered orally., Multiple ascending dose4 of placebo administered orally., Multiple ascending dose5 of placebo administered orally. |
Primary outcome
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
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
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
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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 in people with 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug (time frame: Baseline up to Day 43). The study lists 3 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 31 Dec 2025.