Condition: Obesity · Heart Failure With Preserved Ejection Fraction (HFPEF) · Heart Failure With Mildly Reduced Ejection Fraction · Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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.
This description comes directly from the study's public registry record.
qingjiang ni · +86-0512-69566088 · qingjiang.ni@innoventbio.com
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| Fuwai Hospital, CAMS&PUMC | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06862908