Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 22, 2026
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Phase 2 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06862908). This is a study registration, not published results. Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 141 participants (ACTUAL). Conditions: Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction. Interventions: OTHER: placebo; DRUG: IBI362. Primary outcome measures: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) , From baseline (week 0) to week 36; Body weight change from baseline at week 36 , From baseline (week 0) to week 36. Brief 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/㎡). 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.