AnaCardio AB
The primary purpose of the study is to evaluate the safety and efficacy of 2 doses of AC01 compared to placebo over 12 weeks in participants with chronic advanced HFrEF.
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to evaluate the safety and efficacy of the ghrelin-receptor agonist AC01 compared to placebo in participants with chronic advanced HFrEF. Approximately 400 participants will be randomized to 1 of 3 treatment arms: 3 milligram (mg) AC01, 1 milligram (mg) AC01, or placebo twice daily for 12 weeks. The primary objective is to evaluate the effect of AC01 compared to placebo on cardiac structure and function assessed by echocardiography.
Key Inclusion Criteria: * History of Chronic Heart Failure (CHF) diagnosed greater than or equal to (\>=6) months before screening, and in NYHA Class II to IV at screening. * Chronic advanced HFrEF defined as: * LVEF less than or equal to (\<=) 35 percentage (%) by local reading \>=6 months before screening or a record of LVEF qualitatively described as severely reduced or moderately-severely reduced \>=6 months before screening, and * LVEF \<=35% at the screening echocardiography (confirmed by core lab), and * no known LVEF greater than (\>) 35% (or qualitatively described as less tha…
AC01 tablets for oral administration.
AC01 matching placebo tablets for oral administration.