Study S000440

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Subjects With HFpEF（Heart Failure With Preserved ejectIon Fraction）or HFmrEF（Heart Failure With Mildly Reduced Ejection Fraction）Combined With Obesity

ClinicalTrials.gov record

Registration

Registration: NCT06862908
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 141
Start: 2025-03-26
Primary completion: 2026-09-24
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFPEF); Heart Failure With Mildly Reduced Ejection Fraction
Interventions: OTHER:placebo; DRUG:IBI362
Results posted: FALSE

Registered primary outcomes

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]

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