ObesityPhase 2NCT06862908
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
A Phase 2 study testing IBI362 in people with Obesity and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in Chinese subjects with heart failure with ejection fraction retention/mild ejection fraction reduction (HFpEF/HFmrEF) combined with obesity (BMI≥28kg/㎡). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2025to 11 Feb 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 at the time of signing the informed consent.
- BMI≥28kg/m2.
- NYHA class II-III.
- There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2).
- KCCQ-CSS score < 80 during the screening period and before randomization.
- Medication for chronic diseases: If used before screening, the dose should be stable for ≥4 weeks; If not used before screening, the drug should also be stopped for ≥4 weeks.
- The women of childbearing potential（WOCBP） agrees to use the contraceptive method prescribed in this protocol for the entire study period and for 3 months after the final treatment. Pregnancy test results for fertile women during the screening period must be negative. Female subjects should not breastfeed.
- Voluntarily sign the informed consent form, and be willing to strictly abide by the requirements and restrictions of the informed consent form and the protocol throughout the study period, including but not limited to: maintaining a stable diet and exercise lifestyle, injecting the study drugs as planned, and keeping a study diary.
Who cannot join
- myocardial infarction, stroke, or transient ischemic attacks, hospitalization for acute heart failure requiring any ventilatory and circulatory support devices (such as IABP ,I MPELLA, ECMO, CRRT, etc.) within 3 months before screening.
- Unstable angina pectoris or HF decompensation requiring IV diuretics, IV inotropes, or IV vasodilators within 30 days before screening.
- Poorly controlled hypertension at the screening stage, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. Or systolic blood pressure < 90mmHg during screening.
- Had previously undergone or planned to undergo bariatric surgery during the study period.
- The presence of endocrine diseases or medical history that may significantly affect body weight.
- Previous diagnosis of type 1 diabetes or specific type diabetes.
Show all 16Show fewer
- Use of GLP-1R agonists or glucagon receptor (GLP-1R/GCGR) agonists or GIPR (Glucagon dependent insulinotropic polypeptide) within 3 months before screening receptor) /GLP-1R agonist or GIPR/GLP-1R/GCGR agonist; Participants who stopped using these drugs more than 3 months prior to screening due to lack of efficacy or intolerance should also be excluded.
- Use of insulin in the 3 months prior to screening to control diabetes, except for short-term (cumulative ≤14 days) use of insulin in acute conditions, such as acute illness, hospitalization, or elective surgery. The last insulin treatment was less than 14 days from the screening date.
- History of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or family history.
- Clinically significant gastric empting abnormalities (such as severe diabetic gastroparesis, gastric pyloric obstruction, etc.) or gastrointestinal surgery.
- Active or untreated malignancies were present within 5 years prior to screening, or clinical malignancies were in remission (except in subjects with no recurrence after surgery for basal cell and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate, or papillary thyroid carcinoma).
- A history of atopic reactions (clinical manifestations of severe or multiple allergies) or a history of clinically significant multiple or severe drug allergies, or intolerance to local glucocorticoids, Or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme, linear immunoglobulin A dermatitis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis).
- History of organ transplantation (except corneal transplantation, autologous skin transplantation), or preparing to receive organ transplantation.
- The investigators identified major surgeries that might be planned during the study period that would affect the participants' ability to walk.
- Past suicidal thoughts or behaviors.
- The investigator believes that the subjects are not suitable to participate in the study because of any other factors (including previous serious mental illness) that may affect the efficacy, safety evaluation or compliance of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Subjects With HFpEF（Heart Failure With Preserved ejectIon Fraction）or HFmrEF（Heart Failure With Mildly Reduced Ejection Fraction）Combined With Obesity
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in Chinese subjects with heart failure with ejection fraction retention/mild ejection fraction reduction (HFpEF/HFmrEF) combined with obesity (BMI≥28kg/㎡). This study will enroll about 141 NYHA Class II-III HFpEF/HFmrEF subjects combined with obesity. Eligible participants will be randomly assigned to IBI362 4 mg, IBI362 6 mg, or placebo at a ratio of 1:1:1, randomized by concomitant atrial fibrillation during screening (history/screening ECG).
The trial period includes a 2-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.
- Conditions
- Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
- Being tested
- placebo, IBI362
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo administered subcutaneously(SC), once a week
IBI362Drug
IBI362 administered subcutaneously(SC), once a week
| Study group | Role | What they receive |
|---|---|---|
| IBI362 4.0mg | Experimental | Not described Receives: Drug: IBI362 |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
| IBI362 6.0mg | Experimental | Not described Receives: Drug: IBI362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: From baseline (week 0) to week 36
Body weight change from baseline at week 36
Measured: From baseline (week 0) to week 36
Secondary outcomes (12)
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: From baseline (week 0) to end of treatment (week 52)
Body weight change from baseline at week 52
Measured: From baseline (week 0) to end of treatment (week 52)
Incidence, severity, and association with study drugs of adverse events
Measured: From baseline (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure (SBP)
Measured: From baseline (week 0) to end of treatment (week 52)
Change in Diastolic Blood Pressure(DBP)
Measured: From baseline (week 0) to end of treatment (week 52)
Change in ECG heart rate
The electrocardiogram is performed by a 12-lead electrocardiogram machine
Measured: From baseline (week 0) to end of treatment (week 52)
Change in N terminal pro B type natriuretic peptide（NT-proBNP）
Measured: From baseline (week 0) to end of treatment (week 52)
Change in hypersensitive C-reactive protein（hsCRP）
Measured: From baseline (week 0) to end of treatment (week 52)
Occurrence of serum anti-iBI362 antibody (ADA) before and after administration
Measured: From baseliFrom baseline (week 0) to end of treatment (week 52)ne (week 0) to week 52
Occurrence of neutralizing antibody (NAb) before and after administration
Measured: From baseline (week 0) to end of treatment (week 52)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
Measured: From baseline (week 0) to end of treatment (week 52)
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362
Measured: From baseline (week 0) to end of treatment (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start26 Mar 2025
- Primary completion24 Sep 2026 (estimated)
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
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
- NCT06862908
- Sponsor's protocol ID
- CIBI362G201
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 22 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Subjects With HFpEF（Heart Failure With Preserved ejectIon Fraction）or HFmrEF（Heart Failure With Mildly Reduced Ejection Fraction）Combined With Obesity
- ClinicalTrials.gov ID
- NCT06862908
- Acronym / sponsor ID
- CIBI362G201
- Conditions
- Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 24 Sep 2026 (estimated)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 6 Mar 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 multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in Chinese subjects with heart failure with ejection fraction retention/mild ejection fraction reduction (HFpEF/HFmrEF) combined with obesity (BMI≥28kg/㎡). This study will enroll about 141 NYHA Class II-III HFpEF/HFmrEF subjects combined with obesity. Eligible participants will be randomly assigned to IBI362 4 mg, IBI362 6 mg, or placebo at a ratio of 1:1:1, randomized by concomitant atrial fibrillation during screening (history/screening ECG).
The trial period includes a 2-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI362 4.0mg | Experimental | Drug: IBI362 |
| placebo | Placebo comparator | Other: placebo |
| IBI362 6.0mg | Experimental | Drug: IBI362 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 at the time of signing the informed consent.
- BMI≥28kg/m2.
- NYHA class II-III.
- There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2).
- KCCQ-CSS score < 80 during the screening period and before randomization.
Key exclusion criteria (16 listed)
- myocardial infarction, stroke, or transient ischemic attacks, hospitalization for acute heart failure requiring any ventilatory and circulatory support devices (such as IABP ,I MPELLA, ECMO, CRRT, etc.) within 3 months before screening.
- Unstable angina pectoris or HF decompensation requiring IV diuretics, IV inotropes, or IV vasodilators within 30 days before screening.
- Poorly controlled hypertension at the screening stage, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. Or systolic blood pressure < 90mmHg during screening.
- Had previously undergone or planned to undergo bariatric surgery during the study period.
- The presence of endocrine diseases or medical history that may significantly affect body weight.
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 |
|---|---|---|
| placeboplacebo administered subcutaneously(SC), once a week | Other | placebo |
| IBI362IBI362 administered subcutaneously(SC), once a week | Drug | IBI362 4.0mg, IBI362 6.0mg |
Primary outcome
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame: From baseline (week 0) to week 36
The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Body weight change from baseline at week 36
Time frame: From baseline (week 0) to week 36
12 secondary outcomes
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame: From baseline (week 0) to end of treatment (week 52)
Body weight change from baseline at week 52
Time frame: From baseline (week 0) to end of treatment (week 52)
Incidence, severity, and association with study drugs of adverse events
Time frame: From baseline (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 52)
Change in Diastolic Blood Pressure(DBP)
Time frame: From baseline (week 0) to end of treatment (week 52)
Change in ECG heart rate
Time frame: From baseline (week 0) to end of treatment (week 52)
Change in N terminal pro B type natriuretic peptide（NT-proBNP）
Time frame: From baseline (week 0) to end of treatment (week 52)
Change in hypersensitive C-reactive protein（hsCRP）
Time frame: From baseline (week 0) to end of treatment (week 52)
Occurrence of serum anti-iBI362 antibody (ADA) before and after administration
Time frame: From baseliFrom baseline (week 0) to end of treatment (week 52)ne (week 0) to week 52
Occurrence of neutralizing antibody (NAb) before and after administration
Time frame: From baseline (week 0) to end of treatment (week 52)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
Time frame: From baseline (week 0) to end of treatment (week 52)
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362
Time frame: From baseline (week 0) to end of treatment (week 52)
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 22 Sep 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. 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 2 study testing IBI362 in people with Obesity and Heart Failure With Preserved Ejection Fraction (HFPEF), 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 8 inclusion and 16 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 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (time frame: From baseline (week 0) to week 36). The study lists 2 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 22 Sep 2026.