Phase Ib/IIa Trial With AC01 in Patients With HFrEF

Summary

This is a randomized, double-blind, placebo-controlled two-part study with a multiple escalating dose phase followed by a cohort expansion phase to assess safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF).

Timeline

Start

2023-02-23

Primary completion

2025-10-27

Completion

2025-10-27

Publications

• Lund LH, Barandiaran Aizpurua A, Bollano E, Braun O, Brouwer JLP, Buikema JW, Cannata A, Gardner RS, Handoko ML, Lang CC, Metra M, Sinagra G, Thorvaldsen T, van der Boon RMA, van Essen BJ, Shah SJ, Voors AA, Lam CSP, Pitt B, Solomon SD, Hage C, Stahlberg M, Bernareggi A, Gordon A, Del Sole M, Rosendahl E, Stromberg P, Westerberg G, Edfors R, Petrie MC. Safety, pharmacokinetics, and exploratory efficacy of the oral ghrelin receptor agonist AC01 in heart failure with reduced ejection fraction (GOAL-HF1): a randomised, double-blind, placebo-controlled, phase 1b/2a study. Lancet. 2026 Jun 24:S0140-6736(26)00904-9. doi: 10.1016/S0140-6736(26)00904-9. Online ahead of print.

Drugs

Indications