Obesity and OverweightPhase 1NCT07809945
A Study of IBI3046 in Participants With Overweight or Obesity
A Phase 1 study testing IBI3046 in people with Obesity and Overweight, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- IBI3046
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2026to 9 Oct 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
- 2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
- 3.Body weight change ≤ 5 % within 3 months prior to screening ;
- 4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;
- 5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.
Who cannot join
- 1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
- 2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
- 3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
- 4. Positive screening results for infectious pathogen markers.
- 5. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
- 6. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
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- 7. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
- 8. History of malignant tumors (excluding partial skin cancers) within 5 years.
- 9. Positive screening results for infectious pathogen markers.
- 10. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening.
- 11. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis.
- 12. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk.
- 13. History of malignant tumors (excluding partial skin cancers) within 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101125
Ruihua Dong, 010-80839386, ruihua_dong_rw@163.com
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide
- Conditions
- Obesity and Overweight
- Being tested
- IBI3046, placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3046Drug
subcutaneous injection
placeboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part1-SAD Placebo Control Group | Placebo comparator | Subjects receive single-dose matching placebo for IBI3046 in Part1 SAD phase, across 5 corresponding cohorts. Receives: Drug: placebo |
| Part3-Combination Background Drug + IBI3046 Group | Experimental | All subjects receive active reference drug first, followed by administration of IBI3046 across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD. Receives: Drug: IBI3046 |
| Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group | Placebo comparator | All subjects receive continuous active reference drug. Matching placebo for IBI3046 is administered at corresponding time points across 2 cohorts in Part4 combination phase. Receives: Drug: placebo |
| Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group | Experimental | All subjects receive continuous active reference drug. IBI3046 is administered at different time points across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD. Receives: Drug: IBI3046 |
| Part3-Combination: Reference Drug followed by Placebo Control Group | Placebo comparator | All subjects receive active reference drug first, followed by matching placebo for IBI3046 across 2 corresponding cohorts in Part3 combination phase. Receives: Drug: placebo |
| Part2-MAD Placebo Control Group | Placebo comparator | Subjects receive matching placebo for IBI3046 in Part2 MAD phase, across 3 corresponding cohorts. Receives: Drug: placebo |
| Part2-MAD IBI3046 Treatment Group | Experimental | Subjects receive multiple ascending repeated doses of IBI3046 across 3 different dose cohorts, to evaluate safety, tolerability and steady-state pharmacokinetics. Receives: Drug: IBI3046 |
| Part1-SAD IBI3046 Treatment Group | Experimental | Subjects receive single ascending doses of IBI3046 across 5 different dose cohorts, to evaluate safety, tolerability and pharmacokinetics. Receives: Drug: IBI3046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Event
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Systolic blood pressure will be measured and recorded at each specified time point
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
diastolic blood pressure will be measured and recorded at each specified time point
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with clinically significant changes in physical examination results；
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with abnormal ECG changes before and after administration in each dose group
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Secondary outcomes (9)
renal clearance (CLr)
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Immunogenicity characteristics of IBI3046
To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol.
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.
Measured: up to Day 169 for SAD;up to Day 225 for MAD
Area Under the Curve (AUC) of the serum concentration-time profile
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Maximum Concentration (Cmax) of the drug in serum
Measured: up to Day 3 for SAD;up to Day 57 for MAD
time to maximum concentration (Tmax)
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Elimination Half-life (t1/2)
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Amount of drug excreted in urine (Ae)
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Fraction of dose excreted in urine(Fe)
Measured: up to Day 3 for SAD;up to Day 57 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start23 Sep 2026
- Primary completion16 Jul 2028 (estimated)
- Study completion9 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809945
- Sponsor's protocol ID
- CIBI3046A101
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07809945
- Acronym / sponsor ID
- CIBI3046A101
- Conditions
- Obesity and Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 16 Jul 2028 (estimated)
- Study completion
- 9 Oct 2028 (estimated)
- First posted
- 9 Sep 2026 (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 study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part1-SAD Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive single-dose matching placebo for IBI3046 in Part1 SAD phase, across 5 corresponding cohorts. |
| Part3-Combination Background Drug + IBI3046 Group | Experimental | Drug: IBI3046All subjects receive active reference drug first, followed by administration of IBI3046 across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD. |
| Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group | Placebo comparator | Drug: placeboAll subjects receive continuous active reference drug. Matching placebo for IBI3046 is administered at corresponding time points across 2 cohorts in Part4 combination phase. |
| Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group | Experimental | Drug: IBI3046All subjects receive continuous active reference drug. IBI3046 is administered at different time points across 2 different dose cohorts, to evaluate safety, tolerability, PK and PD. |
| Part3-Combination: Reference Drug followed by Placebo Control Group | Placebo comparator | Drug: placeboAll subjects receive active reference drug first, followed by matching placebo for IBI3046 across 2 corresponding cohorts in Part3 combination phase. |
| Part2-MAD Placebo Control Group | Placebo comparator | Drug: placeboSubjects receive matching placebo for IBI3046 in Part2 MAD phase, across 3 corresponding cohorts. |
| Part2-MAD IBI3046 Treatment Group | Experimental | Drug: IBI3046Subjects receive multiple ascending repeated doses of IBI3046 across 3 different dose cohorts, to evaluate safety, tolerability and steady-state pharmacokinetics. |
| Part1-SAD IBI3046 Treatment Group | Experimental | Drug: IBI3046Subjects receive single ascending doses of IBI3046 across 5 different dose cohorts, to evaluate safety, tolerability and pharmacokinetics. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;
- 2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;
- 3.Body weight change ≤ 5 % within 3 months prior to screening ;
- 4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;
- 5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.
Key exclusion criteria (13 listed)
- 1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.
- 2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.
- 3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.
- 4. Positive screening results for infectious pathogen markers.
- 5. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions 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 |
|---|---|---|
| IBI3046subcutaneous injection | Drug | Part1-SAD IBI3046 Treatment Group, Part2-MAD IBI3046 Treatment Group, Part3-Combination Background Drug + IBI3046 Group, Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment Group |
| placebosubcutaneous injection | Drug | Part1-SAD Placebo Control Group, Part2-MAD Placebo Control Group, Part3-Combination: Reference Drug followed by Placebo Control Group, Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control Group |
Primary outcome
Number of participants with Adverse Event
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Systolic blood pressure will be measured and recorded at each specified time point
Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
diastolic blood pressure will be measured and recorded at each specified time point
Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Number of participants with clinically significant changes in physical examination results；
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Number of participants with abnormal ECG changes before and after administration in each dose group
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
9 secondary outcomes
renal clearance (CLr)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Immunogenicity characteristics of IBI3046
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Area Under the Curve (AUC) of the serum concentration-time profile
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Maximum Concentration (Cmax) of the drug in serum
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
time to maximum concentration (Tmax)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Elimination Half-life (t1/2)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Amount of drug excreted in urine (Ae)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Fraction of dose excreted in urine(Fe)
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
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 19 Oct 2026.
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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.
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 IBI3046 in people with Obesity and Overweight, run by Innovent Biologics (Suzhou) Co. Ltd. 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 Oct 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?
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?
Contact baiyi yan (17710042669, baiyi.yan@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Event (time frame: up to Day 169 for SAD;up to Day 225 for MAD). 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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.