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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
141
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
RECRUITINGChange 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.
Time frame: From baseline (week 0) to week 36
Body weight change from baseline at week 36
Time frame: From baseline (week 0) to week 36
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.
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
The electrocardiogram is performed by a 12-lead electrocardiogram machine
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.