Clinical Trial

A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-03; most recent amendment 2025-07-09.
Status change: Not Yet Recruiting → Recruiting 2025-04-24
Trial Details
NCT Number NCT06862908
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
Enrollment 141 participants
Start Date 2025-04-01
Primary Completion 2026-09-24 (estimated)
Study Completion 2027-02-11 (estimated)
Updated on ClinicalTrials.gov 2025-07-11