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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 4.0mg | Experimental |
| |
| placebo | Placebo Comparator |
| |
| IBI362 6.0mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | placebo administered subcutaneously(SC), once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (week 0) to week 36 |
| Body weight change from baseline at week 36 | From baseline (week 0) to week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qingjiang ni | Contact | +86-0512-69566088 | qingjiang.ni@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, CAMS&PUMC | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
IBI362 administered subcutaneously(SC), once a week |
|
| From baseline (week 0) to end of treatment (week 52) |
| Body weight change from baseline at week 52 | From baseline (week 0) to end of treatment (week 52) |
| Incidence, severity, and association with study drugs of adverse events | From baseline (week 0) to end of treatment (week 52) |
| Change in Systolic Blood Pressure (SBP) | From baseline (week 0) to end of treatment (week 52) |
| Change in Diastolic Blood Pressure(DBP) | 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 | From baseline (week 0) to end of treatment (week 52) |
| Change in N terminal pro B type natriuretic peptide(NT-proBNP) | From baseline (week 0) to end of treatment (week 52) |
| Change in hypersensitive C-reactive protein(hsCRP) | From baseline (week 0) to end of treatment (week 52) |
| Occurrence of serum anti-iBI362 antibody (ADA) before and after administration | 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 | From baseline (week 0) to end of treatment (week 52) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362 | From baseline (week 0) to end of treatment (week 52) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362 | From baseline (week 0) to end of treatment (week 52) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |