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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called IBI362 for people who have heart failure with preserved or mildly reduced heart function (known as HFpEF or HFmrEF) and are also dealing with obesity. The study aims to see how effective and safe this treatment is for individuals with a body mass index (BMI) of 28 or higher. To participate, you need to be at least 18 years old, have a specific level of heart failure, and meet other health guidelines. The trial will involve about 141 participants who will be randomly assigned to receive either IBI362 in two different doses or a placebo (which looks like the medicine but has no active ingredients).

Participants will go through a screening period to ensure they qualify, followed by a year of treatment where neither the patients nor the healthcare providers will know who is receiving the actual treatment versus the placebo. After the treatment period, there will be an additional month of follow-up to check on safety. It’s important for participants to commit to maintaining a stable diet and exercise routine throughout the study. If you’re considering joining, make sure to discuss it with your healthcare provider to see if you meet the eligibility criteria and understand what is involved.

Gender

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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 Grade 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. Medication for underlying diseases: If used before screening, the dose should be stable for ≥4 weeks; If not used before screening, the drug should also be stopped for ≥4 weeks.
• • 7. The fertile subject agrees to use the contraceptive method prescribed in this protocol for the entire study period and for 3 months after the final treatment. Pregnancy test results for fertile women during the screening period must be negative. Female subjects should not breastfeed.
• • 8. Voluntarily sign the informed consent form, and be willing to strictly abide by the requirements and restrictions of the informed consent form and the protocol throughout the study period, including but not limited to: maintaining a stable diet and exercise lifestyle, injecting the study drugs as planned, and keeping a study diary.
• Exclusion criteria:
• • 1. Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris, or transient ischemic attack (TIA) in the 3 months prior to screening.
• • 2. Hospitalization for acute heart failure or use of any respiratory and circulatory AIDS (such as intraaortic balloon counterpulsation (IABP)/interventional artificial heart (IMPELLA)/extracorporeal membrane oxygenation (ECMO)/continuous kidney replacement therapy (CRRT)) within 3 months before screening.
• • 3. Poorly controlled hypertension at the screening stage, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. Or systolic blood pressure \< 90mmHg during screening.
• • 4. Had previously undergone or planned to undergo bariatric surgery during the study period.
• • 5. The presence of endocrine diseases or medical history that may significantly affect body weight.
• • 6. Previous diagnosis of type 1 diabetes or specific type diabetes.
• • 7. Use of GLP-1R agonists or glucagon receptor (GLP-1R/GCGR) agonists or GIPR (Glucagon dependent insulinotropic polypeptide) within 3 months before screening receptor) /GLP-1R agonist or GIPR/GLP-1R/GCGR agonist; Participants who stopped using these drugs more than 3 months prior to screening due to lack of efficacy or intolerance should also be excluded.
• • 8. Use of insulin in the 3 months prior to screening to control diabetes, except for short-term (cumulative ≤14 days) use of insulin in acute conditions, such as acute illness, hospitalization, or elective surgery. The last insulin treatment was less than 14 days from the screening date.
• • 9. History of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or family history.
• • 10. Clinically significant gastric empting abnormalities (such as severe diabetic gastroparesis, gastric pyloric obstruction, etc.) or gastrointestinal surgery.
• • 11. Active or untreated malignancies were present within 5 years prior to screening, or clinical malignancies were in remission (except in subjects with no recurrence after surgery for basal cell and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate, or papillary thyroid carcinoma).
• • 12. A history of atopic reactions (clinical manifestations of severe or multiple allergies) or a history of clinically significant multiple or severe drug allergies, or intolerance to local glucocorticoids, Or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme, linear immunoglobulin A dermatitis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis).
• • 13. History of organ transplantation (except corneal transplantation, autologous skin transplantation), or preparing to receive organ transplantation.
• • 14. The investigators identified major surgeries that might be planned during the study period that would affect the participants' ability to walk.
• • 15. Past suicidal thoughts or behaviors.
• • 16. The investigator believes that the subjects are not suitable to participate in the study because of any other factors (including previous serious mental illness) that may affect the efficacy, safety evaluation or compliance of the study.