Ghrelin agonist as a nOvel mechanism and Alternative myotrope Lacking sympathomimetic adverse effects Heart Failure study
Sponsor: Anacardio
This study focuses on evaluating AC01, an oral ghrelin peptidomimetic small-molecule, in patients with heart failure and reduced ejection fraction (HFrEF). The GOAL-HF1 study is a Phase 1b/2a multicenter trial, randomized and double-blind, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of AC01 in HFrEF patients. The study comprises a dose escalation phase and a cohort expansion phase. It is conducted at specialized heart failure centers in Europe, with the aim of establishing proof-of-concept for future confirmatory studies. The study includes noninvasive measurements of cardiac function and various biomarkers to assess target modulation.
Study Team:
SI: drs. B.J. van Essen
Project coordinator: G.H. de Jong