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RECRUITING
NCT06862908
PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2025-04-01

Completion Date

2027-02-11

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

OTHER

placebo

placebo administered subcutaneously(SC), once a week

DRUG

IBI362

IBI362 administered subcutaneously(SC), once a week

Locations (1)

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China