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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06862908
Phase
PHASE2
Status
Recruiting
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Conditions

  • Heart Failure With Mildly Reduced Ejection Fraction
  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • placebo — OTHER
    placebo administered subcutaneously(SC), once a week
  • IBI362 — DRUG
    IBI362 administered subcutaneously(SC), once a week

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Jul 2025
Primary completion
Sep 24, 2026
Completion
Feb 11, 2027

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI362 4.0mg
  • Placebo Comparator: placebo
  • Experimental: IBI362 6.0mg

Primary Outcome Measure

Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [ Time Frame: From baseline (week 0) to week 36 ]

Central Contacts

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