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

NCT06862908 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the drug IBI362 in adults who have heart failure with preserved or mildly reduced ejection fraction and are also living with obesity.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 141 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-04 · est. completion 2027-02

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06862908 ↗

Description as written by the study sponsor.

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.

Treatments tested

placebo Other

placebo administered subcutaneously(SC), once a week
IBI362 Drug

IBI362 administered subcutaneously(SC), once a week

Main thing measured	Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Conditions studied	Obesity, Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06862908 ↗