A Phase II Study to Test the Safety and Effectiveness of IBI362 in Adults With Heart Failure and Obesity

What this Trial Is About

Researchers are evaluating the effects of IBI362 in Chinese adults with heart failure characterized by preserved or mildly reduced ejection fraction combined with obesity. This randomized, double-blind, placebo-controlled Phase II clinical study aims to assess the safety and efficacy of IBI362 in this specific group of patients, classified as NYHA Class II-III. The study is designed to better understand treatment options for this population, with enrollment of approximately 141 participants. Participants will be randomly assigned to one of three groups receiving either IBI362 at 4 mg, IBI362 at 6 mg, or a placebo, all administered once a week by subcutaneous injection. The intervention period lasts 52 weeks following a 2-week screening period, with a 4-week safety follow-up after treatment completion. Randomization considers the presence of atrial fibrillation during screening. During the study, participants will complete questionnaires such as the Kansas City Cardiomyopathy Questionnaire to assess heart failure symptoms and quality of life, along with measurements of body weight and various blood pressure and heart rate parameters. Safety will be monitored through adverse event reporting and laboratory tests, including antibody development and drug pharmacokinetics. Total study participation spans at least 58 weeks including screening, treatment, and follow-up.

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