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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 22, 2026 (before its estimated September 24, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment closed, study ongoing Start date: Apr 1, 2025 to Mar 26, 2025 · Eligibility criteria expanded, about 24 words · Secondary endpoints: details revised at 1 of 12 entries · 1 more Show 4 more changesShow less
    • Start date: Apr 1, 2025 to Mar 26, 2025
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Site details revised
  2. Eligibility criteria shortened, about 3 wordsv3 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 15, 2025 to Apr 1, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 15, 2025 to Apr 1, 2025
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06862908
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
Enrollment 141 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov