Actively Recruiting
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-07-11
141
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Body mass index (BMI) of 28 kg/m2 or higher
- New York Heart Association (NYHA) class II or III heart failure
- No hospitalizations due to heart failure from screening visit to randomization
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) less than 80 during screening and before randomization
- Stable dose of medications for chronic diseases for at least 4 weeks prior to screening, or stopped such medications for at least 4 weeks if not used before screening
- Women of childbearing potential agree to use prescribed contraception during the study and for 3 months after last treatment; negative pregnancy test during screening; not breastfeeding
- Willingness to sign informed consent and comply with study requirements, including stable diet and exercise, study drug injections, and keeping a study diary
You will not qualify if you...
- Myocardial infarction, stroke, transient ischemic attack, or hospitalization for acute heart failure requiring ventilatory or circulatory support within 3 months before screening
- Unstable angina or heart failure decompensation requiring intravenous diuretics, inotropes, or vasodilators within 30 days before screening
- Poorly controlled hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or systolic blood pressure <90 mmHg during screening
- Previous or planned bariatric surgery during the study period
- Endocrine diseases or medical history significantly affecting body weight
- Previous diagnosis of type 1 diabetes or specific types of diabetes
- Use of GLP-1 receptor agonists, glucagon receptor agonists, or related drugs within 3 months before screening
- Use of insulin within 3 months before screening except short-term use (≤14 days) during acute conditions
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia types 2A or 2B
- Clinically significant gastric emptying abnormalities or gastrointestinal surgery
- Active or untreated malignancies within 5 years prior to screening, except certain skin and cervical cancers in remission
- History of severe allergic reactions or intolerances to local glucocorticoids or severe hypersensitivity reactions
- History of organ transplantation or planned transplantation
- Planned major surgeries during the study that would affect walking ability
- Past suicidal thoughts or behaviors
- Other factors deemed by the investigator to affect study safety, efficacy, or compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Q
qingjiang ni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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