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

NCT06862908 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-07-11

No results posted yet for this study

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

OTHER

placebo

placebo administered subcutaneously(SC), once a week

DRUG

IBI362

IBI362 administered subcutaneously(SC), once a week

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-09-24
Completion
2027-02-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862908 on ClinicalTrials.gov