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

What Was Tested

This registered phase 2 trial tested Mazdutide.

This study will enroll about 141 NYHA Class II-III HFpEF/HFmrEF subjects combined with obesity.

It had three arms (groups): one (experimental), placebo (placebo comparator) and one (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 141 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 at the time of signing the informed consent. NYHA class II-III. There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2). KCCQ-CSS score \< 80 during the screening period and before randomization.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: unstable angina pectoris or hf decompensation requiring iv diuretics, iv inotropes, or iv vasodilators within 30 days before screening; had previously undergone or planned to undergo bariatric surgery during the study period; previous diagnosis of type 1 diabetes or specific type diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

The Mazdutide group and the comparison group ran side by side rather than switching.

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-03-26 with completion listed for 2026-09-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (time frame: From baseline (week 0) to week 36). Body weight change from baseline at week 36 (time frame: From baseline (week 0) to week 36).

It also tracked 12 secondary outcomes, for example Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), Body weight change from baseline at week 52, Incidence, severity, and association with study drugs of adverse events, Change in Systolic Blood Pressure (SBP), Change in Diastolic Blood Pressure(DBP) and Change in ECG heart rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 141 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.