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A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06862908•Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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. Medication for chronic 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 women of childbearing potential（WOCBP） 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, or transient ischemic attacks, hospitalization for acute heart failure requiring any ventilatory and circulatory support devices (such as IABP ,I MPELLA, ECMO, CRRT, etc.) within 3 months before screening.
•2. Unstable angina pectoris or HF decompensation requiring IV diuretics, IV inotropes, or IV vasodilators within 30 days 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.
+6 more criteria

Locations (1)

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

September 24, 2026

Completion Date

February 11, 2027

Last Updated

July 11, 2025

Enrollment

141

ESTIMATED participants

Conditions

ObesityHeart Failure With Preserved Ejection Fraction (HFPEF)Heart Failure With Mildly Reduced Ejection Fraction

Interventions

placebo

OTHER

IBI362

DRUG

Contacts

qingjiang ni

CONTACT

+86-0512-69566088 qingjiang.ni@innoventbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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