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

Phase 2

Recruiting

• Conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFPEF); Heart Failure With Mildly Reduced Ejection Fraction
• Interventions: Drug: IBI362; Other: placebo

• Registration Number: NCT06862908
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-09-24
• Study Completion: 2027-02-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI362 4.0mg	IBI362	-
placebo	placebo	-
IBI362 6.0mg	IBI362	-

Primary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)	From baseline (week 0) to week 36	The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Body weight change from baseline at week 36	From baseline (week 0) to week 36

Secondary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)	From baseline (week 0) to end of treatment (week 52)	The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change in Systolic Blood Pressure (SBP)	From baseline (week 0) to end of treatment (week 52)
Body weight change from baseline at week 52	From baseline (week 0) to end of treatment (week 52)
Incidence, severity, and association with study drugs of adverse events	From baseline (week 0) to end of treatment (week 52)
Change in Diastolic Blood Pressure(DBP)	From baseline (week 0) to end of treatment (week 52)
Change in ECG heart rate	From baseline (week 0) to end of treatment (week 52)	The electrocardiogram is performed by a 12-lead electrocardiogram machine
Change in N terminal pro B type natriuretic peptide（NT-proBNP）	From baseline (week 0) to end of treatment (week 52)
Change in hypersensitive C-reactive protein（hsCRP）	From baseline (week 0) to end of treatment (week 52)
Occurrence of serum anti-iBI362 antibody (ADA) before and after administration	From baseliFrom baseline (week 0) to end of treatment (week 52)ne (week 0) to week 52
Occurrence of neutralizing antibody (NAb) before and after administration	From baseline (week 0) to end of treatment (week 52)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362	From baseline (week 0) to end of treatment (week 52)
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362	From baseline (week 0) to end of treatment (week 52)

Trial Locations

Locations (1)

Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China