Trials / Recruiting
RecruitingNCT06862908
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Obesity
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- Heart Failure With Mildly Reduced Ejection Fraction
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | placebo | placebo administered subcutaneously(SC), once a week |
| DRUG | IBI362 | IBI362 administered subcutaneously(SC), once a week |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-09-24
- Completion
- 2027-02-11
- First posted
- 2025-03-06
- Last updated
- 2025-07-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06862908. Inclusion in this directory is not an endorsement.