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.
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).
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.