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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.

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Title: 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.
Authors: Lund LH; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. Electronic address: lars.lund@ki.se., Barandiarán Aizpurua A; Department of Cardiology, Maastricht University Medical Centre+ (MUMC+), Maastricht, Netherlands; CARIM (Cardiovascular Research Institute Maastricht), Maastricht, Netherlands., Bollano E; Department of Cardiology, Institute of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden., Braun O; Cardiology, Department of Clinical Sciences, Lund University and Skåne University Hospital, Lund, Sweden., Brouwer JLP; ICON Early Phase and Bioanalytical, Groningen, Netherlands., Buikema JW; Amsterdam Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, VU University, Amsterdam University Medical Center, Amsterdam, Netherlands., Cannata A; Department of Cardiology, King's College Hospital London, London, UK., Gardner RS; Scottish National Advanced Heart Failure Service, Golden Jubilee National Hospital, Clydebank, UK., Handoko ML; Department of Cardiology, Transplantation Center Utrecht, University Medical Center Utrecht, Utrecht, Netherlands., Lang CC; Division of Cardiovascular Research, School of Medicine, University of Dundee, Dundee, UK., Metra M; Cardiology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy., Sinagra G; Center for Diagnosis and Treatment of Cardiomyopathies, Cardiothoracovascular Department, University of Trieste, Trieste, Italy., Thorvaldsen T; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden., van der Boon RMA; Department of Cardiology, Cardiovascular Institute, Erasmus Medical Center, Rotterdam, Netherlands., van Essen BJ; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands., Shah SJ; Feinberg Cardiovascular Research Institute, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Voors AA; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands., Lam CSP; National Heart Centre, Singapore; Duke-NUS Medical School, Singapore., Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA., Solomon SD; Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA., Hage C; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden., Stahlberg M; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden., Bernareggi A; Helsinn Healthcare, Lugano, Switzerland., Gordon A; AnaCardio, Solna, Sweden., Del Sole M; AnaCardio, Solna, Sweden., Rosendahl E; AnaCardio, Solna, Sweden., Stromberg P; AnaCardio, Solna, Sweden., Westerberg G; AnaCardio, Solna, Sweden., Edfors R; AnaCardio, Solna, Sweden; Department of Clinical Sciences, Danderyd University Hospital, Division of Cardiovascular Medicine, Karolinska Institutet, Stockholm, Sweden., Petrie MC; School of Cardiovascular and Metabolic Health, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow, UK.
Source: Lancet (London, England) [Lancet] 2026 Jul 18; Vol. 408 (10551), pp. 248-262. Date of Electronic Publication: 2026 Jun 24.
Publication Type: Journal Article; Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase I; Clinical Trial, Phase II
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
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  Data: 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.
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  Data: <searchLink fieldCode="AU" term="%22Lund+LH%22">Lund LH</searchLink>; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. Electronic address: lars.lund@ki.se.<br /><searchLink fieldCode="AU" term="%22Barandiarán+Aizpurua+A%22">Barandiarán Aizpurua A</searchLink>; Department of Cardiology, Maastricht University Medical Centre+ (MUMC+), Maastricht, Netherlands; CARIM (Cardiovascular Research Institute Maastricht), Maastricht, Netherlands.<br /><searchLink fieldCode="AU" term="%22Bollano+E%22">Bollano E</searchLink>; Department of Cardiology, Institute of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.<br /><searchLink fieldCode="AU" term="%22Braun+O%22">Braun O</searchLink>; Cardiology, Department of Clinical Sciences, Lund University and Skåne University Hospital, Lund, Sweden.<br /><searchLink fieldCode="AU" term="%22Brouwer+JLP%22">Brouwer JLP</searchLink>; ICON Early Phase and Bioanalytical, Groningen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Buikema+JW%22">Buikema JW</searchLink>; Amsterdam Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, VU University, Amsterdam University Medical Center, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Cannata+A%22">Cannata A</searchLink>; Department of Cardiology, King's College Hospital London, London, UK.<br /><searchLink fieldCode="AU" term="%22Gardner+RS%22">Gardner RS</searchLink>; Scottish National Advanced Heart Failure Service, Golden Jubilee National Hospital, Clydebank, UK.<br /><searchLink fieldCode="AU" term="%22Handoko+ML%22">Handoko ML</searchLink>; Department of Cardiology, Transplantation Center Utrecht, University Medical Center Utrecht, Utrecht, Netherlands.<br /><searchLink fieldCode="AU" term="%22Lang+CC%22">Lang CC</searchLink>; Division of Cardiovascular Research, School of Medicine, University of Dundee, Dundee, UK.<br /><searchLink fieldCode="AU" term="%22Metra+M%22">Metra M</searchLink>; Cardiology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Sinagra+G%22">Sinagra G</searchLink>; Center for Diagnosis and Treatment of Cardiomyopathies, Cardiothoracovascular Department, University of Trieste, Trieste, Italy.<br /><searchLink fieldCode="AU" term="%22Thorvaldsen+T%22">Thorvaldsen T</searchLink>; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.<br /><searchLink fieldCode="AU" term="%22van+der+Boon+RMA%22">van der Boon RMA</searchLink>; Department of Cardiology, Cardiovascular Institute, Erasmus Medical Center, Rotterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Essen+BJ%22">van Essen BJ</searchLink>; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Shah+SJ%22">Shah SJ</searchLink>; Feinberg Cardiovascular Research Institute, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Voors+AA%22">Voors AA</searchLink>; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Lam+CSP%22">Lam CSP</searchLink>; National Heart Centre, Singapore; Duke-NUS Medical School, Singapore.<br /><searchLink fieldCode="AU" term="%22Pitt+B%22">Pitt B</searchLink>; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.<br /><searchLink fieldCode="AU" term="%22Solomon+SD%22">Solomon SD</searchLink>; Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Hage+C%22">Hage C</searchLink>; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.<br /><searchLink fieldCode="AU" term="%22Stahlberg+M%22">Stahlberg M</searchLink>; Unit of Cardiology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.<br /><searchLink fieldCode="AU" term="%22Bernareggi+A%22">Bernareggi A</searchLink>; Helsinn Healthcare, Lugano, Switzerland.<br /><searchLink fieldCode="AU" term="%22Gordon+A%22">Gordon A</searchLink>; AnaCardio, Solna, Sweden.<br /><searchLink fieldCode="AU" term="%22Del+Sole+M%22">Del Sole M</searchLink>; AnaCardio, Solna, Sweden.<br /><searchLink fieldCode="AU" term="%22Rosendahl+E%22">Rosendahl E</searchLink>; AnaCardio, Solna, Sweden.<br /><searchLink fieldCode="AU" term="%22Stromberg+P%22">Stromberg P</searchLink>; AnaCardio, Solna, Sweden.<br /><searchLink fieldCode="AU" term="%22Westerberg+G%22">Westerberg G</searchLink>; AnaCardio, Solna, Sweden.<br /><searchLink fieldCode="AU" term="%22Edfors+R%22">Edfors R</searchLink>; AnaCardio, Solna, Sweden; Department of Clinical Sciences, Danderyd University Hospital, Division of Cardiovascular Medicine, Karolinska Institutet, Stockholm, Sweden.<br /><searchLink fieldCode="AU" term="%22Petrie+MC%22">Petrie MC</searchLink>; School of Cardiovascular and Metabolic Health, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow, UK.
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  Data: <searchLink fieldCode="JN" term="%222985213R%22">Lancet (London, England)</searchLink> [Lancet] 2026 Jul 18; Vol. 408 (10551), pp. 248-262. <i>Date of Electronic Publication: </i>2026 Jun 24.
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