RecruitingPhase 2

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

China141 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 at the time of signing the informed consent.
✓. BMI≥28kg/m2.
✓. NYHA class II-III.
✓. There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2).
✓. KCCQ-CSS score \< 80 during the screening period and before randomization.
✓. 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.
✓. 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.
✓. 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

What they're measuring

Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)

Timeframe: From baseline (week 0) to week 36

Body weight change from baseline at week 36

Timeframe: From baseline (week 0) to week 36

Trial details

NCT IDNCT06862908

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-24

Contact for this trial

qingjiang ni

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

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