A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
Recruiting
Phase 2
Interventional Study
Obesity
Heart Failure With Preserved Ejection Fraction (HFPEF)
Heart Failure With Mildly Reduced Ejection Fraction
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 141 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
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About This Trial
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 participan…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
1. Age ≥18 at the time of signing the informed consent.
2. BMI≥28kg/m2.
3. NYHA class II-III.
4. There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2).
5. KCCQ-CSS score \< 80 during the screening period and before randomization.
6.…
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