Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Subjects With HFpEF (Heart Failure With Preserved Ejection Fraction) or HFmrEF (Heart Failure With Mildly Reduced Ejection Fraction) Combined With Obesity
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-07-11
141
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of IBI362 in Chinese adults with heart failure characterized by preserved or mildly reduced ejection fraction combined with obesity. This randomized, double-blind, placebo-controlled Phase II clinical study aims to assess the safety and efficacy of IBI362 in this specific group of patients, classified as NYHA Class II-III. The study is designed to better understand treatment options for this population, with enrollment of approximately 141 participants. Participants will be randomly assigned to one of three groups receiving either IBI362 at 4 mg, IBI362 at 6 mg, or a placebo, all administered once a week by subcutaneous injection. The intervention period lasts 52 weeks following a 2-week screening period, with a 4-week safety follow-up after treatment completion. Randomization considers the presence of atrial fibrillation during screening. During the study, participants will complete questionnaires such as the Kansas City Cardiomyopathy Questionnaire to assess heart failure symptoms and quality of life, along with measurements of body weight and various blood pressure and heart rate parameters. Safety will be monitored through adverse event reporting and laboratory tests, including antibody development and drug pharmacokinetics. Total study participation spans at least 58 weeks including screening, treatment, and follow-up.
CONDITIONS
Brief 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 or older at time of consent
- Body mass index (BMI) of 28 kg/m2 or higher
- NYHA heart failure classification of class II or III
- No hospitalizations due to heart failure from screening to randomization
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) below 80 during screening
- Stable dose of medications for chronic diseases for at least 4 weeks before screening, or stopped medications for at least 4 weeks if not used before screening
- Women of childbearing potential must agree to use prescribed contraception during the study and for 3 months after final treatment, have a negative pregnancy test at screening, and not breastfeed
- Willingness to sign informed consent and comply with study requirements, including stable diet and exercise, planned 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 advanced support devices within 3 months before screening
- Unstable angina or heart failure decompensation needing intravenous treatments within 30 days before screening
- Poorly controlled hypertension with systolic blood pressure 160 mmHg or higher, diastolic blood pressure 100 mmHg or higher, or systolic blood pressure below 90 mmHg at screening
- Previous or planned bariatric surgery during the study period
- Presence of endocrine diseases or medical history affecting body weight
- Previous diagnosis of type 1 diabetes or specific diabetes types
- Use of GLP-1R, glucagon receptor, or GIPR agonists within 3 months before screening, or stopped these drugs over 3 months ago due to intolerance or lack of efficacy
- Use of insulin within 3 months before screening except short-term use (less than 14 days) in acute conditions
- History of medullary thyroid carcinoma, multiple endocrine neoplasia 2A or 2B, or family history
- Significant gastric emptying problems or gastrointestinal surgery
- Active or untreated cancers within 5 years before screening, except certain skin or cervical cancers in remission
- History of severe allergic reactions or multiple drug allergies
- History of organ transplantation, except corneal or autologous skin transplants, or planning organ transplantation
- Planned major surgeries affecting ability to walk during study
- Past suicidal thoughts or behaviors
- Any other factors judged by investigators that may affect study participation, safety, or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive weekly subcutaneous injections of either IBI362 or placebo and are monitored for efficacy and safety.
Weekly visits for up to 52 weeks
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
Q
qingjiang ni
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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