A Phase 2 interventional study of AC01 and Placebo in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by AnaCardio AB. Recruiting at 14 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AnaCardio AB · Phase 2, Interventional, and Treatment
Bulgaria, Canada, Czechia, Poland, Slovakia, Spain, Sweden, United States
Among 2,157 studies in Heart Failure with a site in United States — 346 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.
Among the 2,157 studies in Heart Failure with a site in United States, this one is the 296th largest by planned enrollment of the 1,601 interventional ones that give a count, is one of 95 that started in 2026, is one of 227 in phase 2, reaches primary completion later than 322 of the 436 other live ones, and was the 2,119th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →346 of the 2,157 studies in Heart Failure with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18–80
Mayo Clinic · Sites in United States
Ages 18–80 · Healthy volunteers
Tufts Medical Center · Sites in United States
Ages 18+
Stanford University · Sites in United States
Ages 60+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,157 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 313 · Phase 3 177 · Phase 4 139
First in 1983; this study’s year is marked. 95 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 65 across the 1,601 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
746 of 2,157 have an industry lead sponsor. The 10 most frequent:
AnaCardio AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
AnaCardio AB has 2 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
135 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Add all 135 to your calendar (.ics) → With an account.
Among the 2,157 studies in Heart Failure with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of the study is to evaluate the safety and efficacy of 2 doses of AC01 compared to placebo over 12 weeks in participants with chronic advanced HFrEF.
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to evaluate the safety and efficacy of the ghrelin-receptor agonist AC01 compared to placebo in participants with chronic advanced HFrEF. Approximately 400 participants will be randomized to 1 of 3 treatment arms: 3 milligram (mg) AC01, 1 milligram (mg) AC01, or placebo twice daily for 12 weeks. The primary objective is to evaluate the effect of AC01 compared to placebo on cardiac structure and function assessed by echocardiography.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
This study's planned enrollment of 400 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →AnaCardio AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Heart Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Chronic advanced HFrEF defined as:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive AC01 orally twice daily (BID) for 12 weeks.
Drug: AC01
Participants will receive AC01 orally BID for 12 weeks.
Drug: AC01
Participants will receive matching placebo orally BID for 12 weeks.
Other: Placebo
AC01 tablets for oral administration.
AC01 matching placebo tablets for oral administration.
Absolute Change from Baseline in Composite Echocardiography Z-Score at Week 12
The composite echocardiography Z-score integrates left ventricular stroke volume (LVSV), left ventricular end systolic volume (LVESV), left ventricular ejection fraction (LVEF), and left atrial minimal volume index (LAVImin).
Time frame: Baseline and Week 12
Absolute Change from Baseline in LVSV at Week 12
Time frame: Baseline and Week 12
Absolute Change from Baseline in LVEF at Week 12
Time frame: Baseline and Week 12
Absolute Change from Baseline in LVESV at Week 12
Time frame: Baseline and Week 12
Absolute Change From Baseline in LAVImin at Week 12
Time frame: Baseline and Week 12
Absolute Change from Baseline in N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)
Time frame: Baseline and Week 12
Absolute Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 12
The KCCQ is a validated, 23-item, self-administered questionnaire designed to assess health status in participants with congestive heart failure. It evaluates six domains: symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability. Each domain score is transformed to a scale of 0 to 100, with higher scores indicating better health status. The KCCQ-TSS is derived from the domain scores.
Time frame: Baseline and Week 12
Absolute Change From Baseline in Patient Global Impression of Severity (PGIS) at Week 12
PGIS is 1-item questionnaire used to rate the severity of a specific condition. Participants record their perceived severity of heart failure (HF) symptoms, specifically shortness of breath, fatigue, and swelling, and choose 1 response that best described the extent of their symptoms based on a 5-point scale. Response options include none, mild, moderate, severe, and very severe. Higher PGIS scores indicate more severe HF symptoms; lower scores indicate less severe symptoms.
Time frame: Baseline and Week 12
Patient Global Impression of Change (PGIC) at Week 12
The PGIC questionnaire is administered to assess the participant's impression of change in HF symptoms since the initiation of study treatment, specifically changes in shortness of breath, fatigue, and swelling. Participants select one response to describe the overall change (if any) in HF symptoms on a 7-category scale: 7=very much improved, 6 =much improved, 5 =minimally improved, 4 =no change, 3 =minimally worse, 2 =much worse, and 1 =very much worse. Higher PGIC scores indicate greater improvement in HF symptoms, while lower scores indicate worsening or no change.
Time frame: At Week 12
Number of Participants With Death, Cardiovascular Death, Hospitalization, Cardiovascular Hospitalization, Heart Failure Hospitalization, Heart Failure Events, Other Adjudicated Events, and Listed for Heart Transplantation
Time frame: At Week 12
Change From Baseline in Guideline-directed Medical Therapy (GDMT) Use for HFrEF at Week 12
Time frame: Baseline and Week 12
Absolute Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and Week 12
Number of Participants With Dialysis
Time frame: At Week 12
Absolute Change from Baseline in Council on Nutrition Appetite Questionnaire (CNAQ) Total Score
The CNAQ is an 8-item, self-administered questionnaire used to assess appetite over time. Each item is scored on a scale of 1 to 5, and the total score is calculated as the sum of all item scores. The instrument has demonstrated acceptable psychometric properties, including internal consistency, construct validity, and predictive validity, for assessing appetite in participants with heart failure. Higher CNAQ scores indicate better appetite.
Time frame: Baseline and Week 12
Absolute Change From Baseline in New York Heart Association (NYHA) Class
Time frame: Baseline and Week 12
AUC,ss: Area Under the Concentration-Time Curve at Steady State of AC01 and its Metabolite M6
Population pharmacokinetic parameters
Time frame: At Week 4 and Week 12
Cmax,ss: Maximum Observed Concentration at Steady State of AC01 and its Metabolite M6
Population pharmacokinetic parameters
Time frame: At Week 4 and Week 12
Tmax,ss: Time to Reach Maximum Concentration at Steady State
Population pharmacokinetic parameters
Time frame: At Week 4 and Week 12
Ctrough: Trough concentration at steady state of AC01 and its Metabolite M6
Population pharmacokinetic parameters
Time frame: At Week 4 and Week 12
Rac (Cmax): Accumulation Ratio of Cmax for AC01 and its Metabolite M6
Population pharmacokinetic parameters. Accumulation ratio of Cmax calculated as Cmax at Week 12/Cmax at Week 4.
Time frame: At Week 4 and Week 12
Rac (AUC): Accumulation Ratio of AUC for AC01 and its Metabolite M6
Population pharmacokinetic parameters. Accumulation ratio of AUC calculated as AUC at Week 12/AUC at Week 4.
Time frame: At Week 4 and Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time frame: From first dose of study drug up to end of follow up (up to Week 16)
Plan to share: Yes — Individual de-identified participant data 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. Proposals should be directed to the Central Contact Person.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Links to the Study Protocol and Statistical Analysis Plan will be made available on ClinicalTrials.gov
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2028, 20 months later.
Of 73 industry-sponsored phase 2 interventional studies under Heart Failure, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 31. This study's planned 20 months is close to that.
Counting every sponsor, half of 184 studies reached it within 29 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Bulgaria, Canada, Czechia, Poland, Slovakia, Spain, Sweden, United States
Bulgaria, Canada, Czechia, Poland, Slovakia, Spain, Sweden, United States
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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AnaCardio AB