AC01 / AnaCardio - LARVOL DELTA

The Orally Available Ghrelin Receptor-Agonist AC01 Improves Systolic Function in HFrEF Mice and Nonhuman Primates. (PubMed, JACC Basic Transl Sci) - "Additionally, AC01 improved autonomic balance by increasing parasympathetic and decreasing sympathetic activity. Overall, AC01 produced rapid, consistent, and sustained improvements in systolic function across species, supporting its potential as a novel, load-independent inotropic therapy for heart failure."

Journal • Preclinical • Cardiovascular • Congestive Heart Failure • Heart Failure

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. (PubMed, Lancet) - P1/2 | "In patients with HFrEF, AC01 over 28 days appeared safe and well tolerated, and no major harms were identified in this early-phase study. These findings support further investigations of AC01 in larger studies."

Journal • P1/2 data • PK/PD data • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Hypotension • Otorhinolaryngology • Pain • Pulmonary Disease • Ventricular Tachycardia • Vertigo • TNNI3

GOAL-HF2: A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: AnaCardio AB

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=58 | Completed | Sponsor: AnaCardio AB | Active, not recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Oct 2025

Trial completion • Trial completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

The ghrelin receptor agonist AC01 improves cardiomyocyte contractility through Gαi signalling and without Ca2+ mobilization. (PubMed, Cardiovasc Res) - No abstract available

Journal

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=62 | Active, not recruiting | Sponsor: AnaCardio AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=62 | Recruiting | Sponsor: AnaCardio AB | Trial completion date: Jun 2025 ➔ Feb 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

The ghrelin receptor agonist AC01 improves cardiac function in non-human primates and in mice with heart failure by increasing cardiomyocyte contractility (ESC 2024) - "AC01 improved CO, SV, and EF in HF mice by increasing contractility in a load-independent fashion. AC01 increased cardiomyocyte contractility without affecting Ca2+ transient amplitudes, through ghrelin receptor Gαi signalling, leading to reduced phosphorylation of cTnI. AC01 improved left ventricle systolic function in monkeys."

Preclinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • TNNI3

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: AnaCardio AB | Trial completion date: Nov 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: AnaCardio AB | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

GOAL-HF1: Phase Ib/IIa Trial With AC01 in Patients With HFrEF (clinicaltrials.gov) - P1/2 | N=80 | Not yet recruiting | Sponsor: AnaCardio AB

New P1/2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure