Trial · Interventional
Active, not recruitingPhase 2Registry dataA Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
Overview
- Status
- Active, not recruiting
- Phase
- Phase 2
- Enrollment
- 141 participants (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Design
- Randomized · Double masking
- Countries
1 country
China
- Start
- 26 Mar 2025
- Primary completion
- 24 Sept 2026 (estimated)
- Completion
- 11 Feb 2027 (estimated)
- First posted
- 6 Mar 2025
- Last update posted
- 22 Sept 2026
- Conditions
- Obesity · Heart Failure With Preserved Ejection Fraction (HFPEF) · Heart Failure With Mildly Reduced Ejection Fraction
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
NCT0686290826 Mar 2025 to est. 11 Feb 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- placeboOther
- IBI362Drug
Arms3
Experimental
IBI362 4.0mg
Placebo comparator
placebo
Experimental
IBI362 6.0mg
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame · From baseline (week 0) to week 36
Registry description
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
Time frame · From baseline (week 0) to week 36
Secondary outcomes(12)
Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time frame · From baseline (week 0) to end of treatment (week 52)
Registry description
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 52
Time frame · From baseline (week 0) to end of treatment (week 52)
Incidence, severity, and association with study drugs of adverse events
Time frame · From baseline (week 0) to end of treatment (week 52)
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 52)
Change in Diastolic Blood Pressure(DBP)
Time frame · From baseline (week 0) to end of treatment (week 52)
Change in ECG heart rate
Time frame · From baseline (week 0) to end of treatment (week 52)
Registry description
The electrocardiogram is performed by a 12-lead electrocardiogram machine
Change in N terminal pro B type natriuretic peptide(NT-proBNP)
Time frame · From baseline (week 0) to end of treatment (week 52)
Change in hypersensitive C-reactive protein(hsCRP)
Time frame · From baseline (week 0) to end of treatment (week 52)
Occurrence of serum anti-iBI362 antibody (ADA) before and after administration
Time frame · 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
Time frame · From baseline (week 0) to end of treatment (week 52)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
Time frame · From baseline (week 0) to end of treatment (week 52)
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362
Time frame · From baseline (week 0) to end of treatment (week 52)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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