Heart Failure With Reduced Ejection FractionPhase 1/2GOAL-HF1NCT05642507
Phase Ib/IIa Trial With AC01 in Patients With HFrEF
A Phase 1/2 study testing AC01 in people with Heart Failure With Reduced Ejection Fraction, run by AnaCardio AB at 14 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- AC01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 23 Feb 2023to 27 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female out-patients of any ethnicity, between 18-80 years (inclusive), with stable HFrEF.
- Chronic HF for at least 6 months duration defined by history with current NYHA class II-III severity.
- LVEF ≤40% by TTE more than 6 months before screening and again at screening (screening measurement confirmed by echocardiography core lab).
- Sinus rhythm with mean resting heart rate 55-90 bpm.
- Cardiac Index 0.5-2.4 measured by Innocor at screening and Day -1. Screening measurement confirmed by core lab.
- Transvenous ICD for primary prevention in place and active (as long as it is not subcutaneous).
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- Optimal guideline-based medical therapy for HFrEF as judged by the Investigator, at stable doses for ≥2 weeks with no intention to change dosing during trial duration.
- Male and female out-patients of any ethnicity, between 18-80 years (inclusive), with stable HFrEF.
- Chronic HF for at least 6 months duration defined by history with current NYHA class II-III severity.
- LVEF ≤40% by TTE more than 6 months before screening and again at screening (screening measurement confirmed by echocardiography core lab).
- Sinus rhythm or permanent, persistent or paroxysmal AFF (AFF at screening capped at ≥25% of enrolled patients) with mean resting heart rate 55-90 bpm measured as part of vital signs, at screening and on Day -1. Mean defined as mean of 3 separate measurements 1 minute apart.
- Transvenous ICD for primary prevention in place and active (i.e., subcutaneous ICD not accepted).
- Optimal guideline-based medical therapy for HFrEF as judged by the Investigator, at stable doses for ≥2 weeks with no intention to change dosing during trial duration.
Who cannot join
- Any cardiac rhythm that does or could interfere with ECG or TTE interpretation, including but not limited to permanent or persistent atrial fibrillation or flutter or paroxysmal atrial fibrillation or flutter with an episode in the last 3 months, frequent premature ventricular contractions, or atrial or ventricular pacing
- Ongoing or planned mechanical circulatory support, treatment with any IV vasoactive drugs (vasodilators, inotropes, or vasopressors) or diuretics, and/or dialysis or hemofiltration or ultrafiltration.
- Probable alternative explanations for symptoms or signs (e.g., but not limited to, known primary cardiomyopathy [hypertrophic, constrictive, restrictive, infiltrative, congenital]). Primary uncorrected hemodynamically significant valve disease, right-sided HF not due to left-sided HF.
- History of aborted cardiac arrest (cardiac arrest in the setting of myocardial infarction is allowed).
- Hospitalized for HF or received IV diuretics, vasodilators, or inotropes for HF ≤30 days.
- Clinical diagnosis of acute coronary syndrome or stroke ≤30 days.
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- PCI or percutaneous valve intervention ≤30 days or planned.
- Angina pectoris ≤30 days.
- Any cardiovascular procedure planned during study duration.
- Hospitalized or unplanned visit to the emergency department for any reason in last 30 days; patient is eligible 30 days from discharge from hospital.
- Use of any drugs or substances known to be strong inducers of CYP3A4 enzyme within 28 days prior to the first dose of study drug and/or planned to be used during the overall study period until the day after the final dose of study drug (e.g., rifampin, phenytoin).
- eGFR by CKD-EPI <30 mL/min/1.73 m2 at screening or at Day -1.
- Serum or plasma potassium <3.5 or >5.2 mEq/L at screening or at Day -1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times upper limit of normal (ULN) or total bilirubin >2 times ULN at screening or at Day -1 or known cirrhosis or severe liver or pancreatic disease, or Gilbert's syndrome.
- Any condition that in the opinion of the Investigator may interfere with adherence to, or makes patient not suitable for, entry into the study.
- Mean systolic blood pressure <90 mmHg or >140 mmHg, sitting after at least 5 minutes rest at screening or at Day -1.
- Any of the following ECG findings at screening or at Day -1: atrial or ventricular pacing, QTcF >450 ms for males and >470 ms for females, AV block I with PQ >240 ms, AV block II or III. In the case of non-paced QRS prolongation >120 ms, the QTcF is allowed to be up to but not greater than 470 ms.
- Any cardiac rhythm other than AFF that does or could interfere with ECG or TTE interpretation, including but not limited to >20% of ventricular contractions on ECG strips being premature ventricular contractions including doublets, triplets, bigeminy or trigeminy, or atrial or ventricular pacing.
- Ongoing or planned mechanical circulatory support, treatment with any IV vasoactive drugs (vasodilators, inotropes, or vasopressors) or diuretics, and/or dialysis or hemofiltration or ultrafiltration.
- Probable alternative explanations for symptoms or signs (e.g., but not limited to, known primary cardiomyopathy [hypertrophic, constrictive, restrictive, infiltrative, congenital]). Primary uncorrected hemodynamically significant valve disease, right-sided HF not due to left-sided HF.
- History of aborted cardiac arrest (cardiac arrest in the setting of myocardial infarction is allowed).
- Hospitalized for HF or received IV diuretics, vasodilators, or inotropes for HF ≤30 days.
- Clinical diagnosis of acute coronary syndrome or stroke ≤30 days.
- PCI or percutaneous valve intervention ≤30 days or planned.
- Angina pectoris ≤30 days.
- Any cardiovascular procedure planned during study duration.
- Hospitalized for cardiovascular or other disease in last 30 days as per Investigator discretion; patient is eligible 30 days from discharge from hospital.
- Use of any drugs or substances known to be strong inducers of CYP3A4 enzyme within 28 days prior to the first dose of study drug and/or planned to be used during the overall study period until the day after the final dose of study drug (e.g., rifampin, phenytoin).
- eGFR by CKD-EPI <30 mL/min/1.73 m2 at screening.
- Serum or plasma potassium >5.2 mEq/L at screening. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times upper limit of normal (ULN) or total bilirubin >2 times ULN at screening or at Day -1 or known cirrhosis or severe liver or pancreatic disease, or Gilbert's syndrome.
- Any condition that in the opinion of the Investigator may interfere with adherence to, or makes patient not suitable for, entry into the study.
- Mean systolic blood pressure <90 mmHg or >140 mmHg, sitting after at least 5 minutes rest at screening or at Day -1.
- Any of the following ECG findings at screening or at Day -1: atrial or ventricular pacing, QTcF >450 ms for males and >470 ms for females, AV block I with PQ >240 ms, AV block II or III. In the case of non-paced QRS prolongation >120 ms, the QTcF is allowed to be up to but not greater than 470 ms.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Netherlands5 sites
Amsterdam University Medical Centre
Amsterdam, 1081 HV
University Medical Centre Groningen/ICON
Groningen, 9718 GZ
Maastricht Heart and Vascular Center
Maastricht, 6229 HX
Erasmus Medical Centre
Rotterdam, 3015 GD
University Medical Center
Utrecht
United Kingdom4 sites
Ninewells Hospital and Medical School
Dundee, DD1 9SY
University of Glasgow, Institute of Cardiovascular & Medical Sciences
Glasgow, G12 8QQ
Golden Jubilee National Hospital
Glasgow, G81 4DY
King's College Hospital
London, SE5 9RS
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 413045
Skånes Universitetssjukhus Lund
Lund, 222 42
Karolinska University Hospital
Stockholm, 171 76
Italy2 sites
Spedali Civilia di Brescia
Brescia, 25123
Azienda Sanitaria Universitaria Integrata
Trieste, 34149
About this study
Official title: Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled, Safety, Tolerability, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Phase Ib/IIa Clinical Trial With AC01 in Patients With HFrEF
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).
Read the detailed description
During the dose escalation phase, patients were given AC01 orally twice daily for seven days. In the cohort expansion phase, patients were given AC01 orally twice daily for 28 days at dose levels selected on the basis of results of the dose escalation phase.
- Being tested
- AC01, Placebo Minitablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC01Drug
AC01 Minitablets
Placebo MinitabletsDrug
Placebo Minitablets are indistinguishable from active AC01 Minitablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Active (AC01) Minitablets 0.1 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 7 days. Receives: Drug: AC01 |
| Cohort A2: Active (AC01) Minitablets 0.3 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 7 days. Receives: Drug: AC01 |
| Cohort A3: Active (AC01) Minitablets 1 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 7 days. Receives: Drug: AC01 |
| Cohort A4: Active (AC01) Minitablets 3 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 7 days. Receives: Drug: AC01 |
| Placebo Minitablets | Placebo comparator | Participants will receive matching placebo orally BID for 7 days. Receives: Drug: Placebo Minitablets |
| Cohort B1: Active (AC01) Minitablets 1 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 28 days. Receives: Drug: AC01 |
| Cohort B2: Active (AC01) Minitablets 3 mg | Experimental | Participants will receive AC01 orally twice daily (BID) for 28 days. Receives: Drug: AC01 |
| Cohort B3: Placebo Minitablets | Placebo comparator | Participants will receive matching placebo orally BID for 28 days. Receives: Drug: Placebo Minitablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse Events (AEs)
Number of participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs).
Measured: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Safety and tolerability: Vital signs.
Change from baseline in pulse rate.
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion)
Safety and tolerability: Vital signs.
Change from baseline in systolic blood pressure.
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Vital signs.
Change from baseline in body weight.
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Electrocardiogram (ECG).
Number of participants with brady- or tachyarrhythmia.
Measured: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Safety and tolerability: Electrocardiogram (ECG).
Change from baseline in RR-, PR-, QRS- QTc intervals.
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Change from baseline in N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP).
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Change from baseline in hs-Troponin-I
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Change from baseline in eGFR
Measured: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Secondary outcomes (3)
Pharmacokinetics of AC01 and its major metabolite: Cmax.
Maximal observed concentration (Cmax).
Measured: Up to Day 8 during dose escalation phase and up to Day 32 during cohort expansion phase.
Pharmacokinetics of AC01 and its major metabolite: AUC
Area under the concentration-time curve.
Measured: Up to Day 8 during dose escalation phase and up to Day 32 during cohort expansion phase.
Pharmacodynamics: Mechanistic circulating biomarkers.
Growth hormone (GH), cystatin C, insulin (fasting), aldosterone, cortisol, ACTH and prolactin.
Measured: Up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start23 Feb 2023
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, escalating, multiple doses
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnaCardio AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars H Lund, MD PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642507
- Sponsor's protocol ID
- AC01-01
- Acronym
- GOAL-HF1
- Status last verified
- May 2026
- First submitted
- 18 Nov 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Disclosure of study data as per EU Clinical Trial Regulation principles. Publication of study data in peer-reviewed scientific journals. Individual de-identified participant data that underlie the results reported in this article, the study protocol and the clinical study report will be shared with qualified scientific and medical researchers whose proposed use of data has been approved by the study executive committee, beginning 9 months and ending 36 months following article publication.
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 Jul 18;408(10551):248-262. doi: 10.1016/S0140-6736(26)00904-9. Epub 2026 Jun 24.
PubMed 42341796
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled, Safety, Tolerability, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Phase Ib/IIa Clinical Trial With AC01 in Patients With HFrEF
- ClinicalTrials.gov ID
- NCT05642507
- Acronym / sponsor ID
- GOAL-HF1 / AC01-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AnaCardio ABIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
During the dose escalation phase, patients were given AC01 orally twice daily for seven days. In the cohort expansion phase, patients were given AC01 orally twice daily for 28 days at dose levels selected on the basis of results of the dose escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Sequential, escalating, multiple doses
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Active (AC01) Minitablets 0.1 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 7 days. |
| Cohort A2: Active (AC01) Minitablets 0.3 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 7 days. |
| Cohort A3: Active (AC01) Minitablets 1 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 7 days. |
| Cohort A4: Active (AC01) Minitablets 3 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 7 days. |
| Placebo Minitablets | Placebo comparator | Drug: Placebo MinitabletsParticipants will receive matching placebo orally BID for 7 days. |
| Cohort B1: Active (AC01) Minitablets 1 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 28 days. |
| Cohort B2: Active (AC01) Minitablets 3 mg | Experimental | Drug: AC01Participants will receive AC01 orally twice daily (BID) for 28 days. |
| Cohort B3: Placebo Minitablets | Placebo comparator | Drug: Placebo MinitabletsParticipants will receive matching placebo orally BID for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female out-patients of any ethnicity, between 18-80 years (inclusive), with stable HFrEF.
- Chronic HF for at least 6 months duration defined by history with current NYHA class II-III severity.
- LVEF ≤40% by TTE more than 6 months before screening and again at screening (screening measurement confirmed by echocardiography core lab).
- Sinus rhythm with mean resting heart rate 55-90 bpm.
- Cardiac Index 0.5-2.4 measured by Innocor at screening and Day -1. Screening measurement confirmed by core lab.
Key exclusion criteria (32 listed)
- Any cardiac rhythm that does or could interfere with ECG or TTE interpretation, including but not limited to permanent or persistent atrial fibrillation or flutter or paroxysmal atrial fibrillation or flutter with an episode in the last 3 months, frequent premature ventricular contractions, or atrial or ventricular pacing
- Ongoing or planned mechanical circulatory support, treatment with any IV vasoactive drugs (vasodilators, inotropes, or vasopressors) or diuretics, and/or dialysis or hemofiltration or ultrafiltration.
- Probable alternative explanations for symptoms or signs (e.g., but not limited to, known primary cardiomyopathy [hypertrophic, constrictive, restrictive, infiltrative, congenital]). Primary uncorrected hemodynamically significant valve disease, right-sided HF not due to left-sided HF.
- History of aborted cardiac arrest (cardiac arrest in the setting of myocardial infarction is allowed).
- Hospitalized for HF or received IV diuretics, vasodilators, or inotropes for HF ≤30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC01AC01 Minitablets | Drug | Cohort A1: Active (AC01) Minitablets 0.1 mg, Cohort A2: Active (AC01) Minitablets 0.3 mg, Cohort A3: Active (AC01) Minitablets 1 mg, Cohort A4: Active (AC01) Minitablets 3 mg, Cohort B1: Active (AC01) Minitablets 1 mg, Cohort B2: Active (AC01) Minitablets 3 mg |
| Placebo MinitabletsPlacebo Minitablets are indistinguishable from active AC01 Minitablets. | Drug | Cohort B3: Placebo Minitablets, Placebo Minitablets |
Primary outcome
Safety and tolerability: Adverse Events (AEs)
Time frame: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Number of participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs).
Safety and tolerability: Vital signs.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion)
Change from baseline in pulse rate.
Safety and tolerability: Vital signs.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in systolic blood pressure.
Safety and tolerability: Vital signs.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in body weight.
Safety and tolerability: Electrocardiogram (ECG).
Time frame: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Number of participants with brady- or tachyarrhythmia.
Safety and tolerability: Electrocardiogram (ECG).
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in RR-, PR-, QRS- QTc intervals.
Safety and tolerability: Clinical laboratory evaluations.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP).
Safety and tolerability: Clinical laboratory evaluations.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in hs-Troponin-I
Safety and tolerability: Clinical laboratory evaluations.
Time frame: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Change from baseline in eGFR
3 secondary outcomes
Pharmacokinetics of AC01 and its major metabolite: Cmax.
Time frame: Up to Day 8 during dose escalation phase and up to Day 32 during cohort expansion phase.
Pharmacokinetics of AC01 and its major metabolite: AUC
Time frame: Up to Day 8 during dose escalation phase and up to Day 32 during cohort expansion phase.
Pharmacodynamics: Mechanistic circulating biomarkers.
Time frame: Up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 42341796Lund 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 Jul 18;408(10551):248-262. doi: 10.1016/S0140-6736(26)00904-9. Epub 2026 Jun 24.
- Individual participant dataSharing planned: Yes. Disclosure of study data as per EU Clinical Trial Regulation principles. Publication of study data in peer-reviewed scientific journals. Individual de-identified participant data that underlie the results reported in this article, the study protocol and the clinical study report will be shared with qualified scientific and medical researchers whose proposed use of data has been approved by the study executive committee, beginning 9 months and ending 36 months following article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars H Lund, MD PhD study chair
Karolinska University Hospital
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AC01 in people with Heart Failure With Reduced Ejection Fraction, run by AnaCardio AB at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands, United Kingdom, Sweden, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Adverse Events (AEs) (time frame: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.