A Phase 3 interventional study of ARRY-371797 (PF-07265803) and Placebo in Dilated Cardiomyopathy and Lamin A/C Gene Mutation, sponsored by Pfizer. Terminated at 107 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
Among 64 studies in Cardiomyopathy, Dilated with a site in United States — 14 open to participants now, 20 under way, 2 of them phase 3. Cardiomyopathy, Dilated · United States.
Among the 64 studies in Cardiomyopathy, Dilated with a site in United States, this one is the 13th largest by enrollment of the 42 interventional ones that give a count, is one of 6 that started in 2018, is one of 4 in phase 3, and was the 38th registered.
255 studies on the registry are indexed under Cardiomyopathy, Dilated; 66 are open to participants now.
Browse Cardiomyopathy, Dilated studies →14 of the 64 studies in Cardiomyopathy, Dilated with a site in United States are open now. Recruiting first, the newest first:
Affinia Therapeutics · Sites in United States, Canada
Ages 18–70
Kardigan, Inc. · Sites in United States, Belgium, Denmark and 8 more countries
Ages 18+
Nuevocor Pte. Ltd. · Sites in United States
Ages 18+
Rocket Pharmaceuticals Inc. · Sites in United States
Ages 18–65
Kardigan, Inc. · Sites in United States, Belgium, Denmark and 8 more countries
Ages 18+
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 53 Cardiomyopathy, Dilated studies recruiting now, 30 (57%) set no upper age limit and 15 (28%) stop at 75 or younger; 13 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · 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.
64 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 13 · Phase 2 17 · Phase 3 5 · Phase 4 2
First in 1992; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 77 is above the median of 43 across 145 interventional studies indexed under Cardiomyopathy, Dilated.
Median enrollment 37 across the 42 interventional studies, 166 across the 20 observational. Of the 38 that completed or were terminated, 16 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 64 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
Pfizer has 3 studies filed under Cardiomyopathy, Dilated — fewer than ten, so there is no comparison to draw.
7 of the studies in Cardiomyopathy, Dilated with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07210723Phase 3Kardigan, Inc.A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy | 2027-09 |
| NCT04638621Ohio State UniversityDilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Ancillary Study | 2026-12 |
| NCT06688396Lancaster General HospitalDilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT) | 2026-12 |
| NCT04476901Joshua M HareAdministration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy | 2027-04 |
| NCT06464588Emory UniversityA Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM) | 2027-07 |
Add all 7 to your calendar (.ics) → With an account.
Among the 64 studies in Cardiomyopathy, Dilated with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.
Selected Key Inclusion Criteria:
Selected 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 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally
Drug: ARRY-371797 (PF-07265803) · Other: Placebo
ARRY-371797 (PF-07265803) tablet orally
Drug: ARRY-371797 (PF-07265803)
400 mg twice daily (BID)
BID
Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional. Study discontinuation \& death were incorporated into endpoint definition through ranking in hypothesis testing of treatment difference. Missing data resulting from study discontinuation were imputed using control-based multiple imputation method to estimate treatment effect.
Time frame: Baseline, Week 24
Change From Baseline in 6 MWT at Weeks 4 and 12
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional.
Time frame: Baseline, Week 4, Week 12
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24
The KCCQ measured the effects of symptoms, functional (physical) limitations, and psychological distress on an individual's health-related quality of life. It contains 23 items, which assessed the ability to perform activities of daily living, frequency and severity of symptoms, the impact of these symptoms, and health-related quality of life. PL was a single questionnaire with score range of 0 to 100, where higher scores reflected better physical functioning status. TSS included frequency and severity of symptoms, and the impact of these symptoms. TSS scores were transformed to a range of 0 to 100, where higher scores reflected better health status.
Time frame: Baseline, Week 12, Week 24
Number of Participants With Improvement From Baseline in Patient Global Impression of Severity (PGI-S) Score at Weeks 12 and 24
PGI-S is a global index that rate the severity of the disease using a 5-point scale. In this outcome the number of participants with improvements in PGI-S the severity of their heart failure symptoms and in the severity of their PL were reported. Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse).
Time frame: Week 12, Week 24
Number of Participants With Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Weeks 12 and 24
PGI-C is a global index that rate the severity of the disease using a 7-point scale. In this outcome the number participants with improvements in their heart failure symptoms and "in their physical activity limitations?", were reported. Measured by the scale of: very much better, moderately better, a little better, no change, a little worse, moderately worse, very much worse (listed from better to worse).
Time frame: Week 12, Week 24
Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Weeks 4, 12, and 24
NT pro-BNP is a cardiac biomarker that is released in the blood in response to changes in the pressure inside of the heart. Levels go up when heart failure develops or gets worse, and levels go down when heart failure is stable or improves. This biomarker helps to measure the changes in the severity of heart failure over time in response to therapy.
Time frame: Baseline, Week 4, Week 12, Week 24
Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF)
Defined as the time from randomization to the first occurrence of any event of death due to any cause, or worsening heart failure (HF-related hospitalization or HF-related urgent care visit). Kaplan-Meier method and cox regression model were used for analysis.
Time frame: Maximum up to 212.28 weeks (maximum exposure was 208 weeks)
Overall Survival (OS)
OS was defined as time from randomization to death due to any cause. Participants who did not have a death date were censored for OS at their last contact date. Kaplan-Meier method and cox regression model were used for analysis.
Time frame: From randomization up to death due to any cause or censored date, maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With Treatment Emergent Adverse Events (AEs) and by Severity
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 30 days after last dose. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all Non-SAEs. Grade \>=3 AEs meant severe AEs.
Time frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With Laboratory Test Abnormalities
Following parameters were analyzed for laboratory examination: hematology (eosinophils, erythrocytes, hemoglobin, hematocrit, granulocytes, leukocytes, lymphocytes, monocytes, platelets, neutrophils, nucleated erythrocytes); blood chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, C-reactive protein, calcium, chloride, creatinine, creatine kinase, epidermal growth factor receptor, follicle stimulating hormone, gamma glutamyl transferase, glucose, magnesium, N-Terminal ProB-type natriuretic peptide, phosphate, potassium, protein, sodium, potassium, thyrotropin, troponin I, troponin T, urate).
Time frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants According to Categorization of Abnormal Vital Signs
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, heart rate, and body weight. Vital sign abnormalities criteria included: a) systolic blood pressure (mmHg): decrease (change \<= -20, or value \<90) and increase (change \>=20, or value \>140); b) diastolic blood pressure (mmHg): decrease (change \<= -15, or value \<60) and increase (change \>=15, or value \>90); c) heart Rate (bpm) decrease: (change \<= -15, or value \<50) and increase (change \>=15, or value \>100); d) weight: (kg) decrease (Change \<= -7%) and increase (Change \> =7%).
Time frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants According to Categorization of Electrocardiogram (ECG) Data
Following parameters were analyzed: heart rate, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, and Fridericia's correction (QTcF) interval. Criteria for notable ECG values were as follows: QT interval (in millisecond \[msec\]) new (newly occurring post-baseline value) greater than (\>) 450, 480, 500, increase from baseline \>30, increase from baseline \>60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) \> 450, 480, 500, increase from baseline \>30, increase from baseline \>60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) \> 450, 480, 500, increase from baseline \>30, increase from baseline \>60; heart rate in bpm new (newly occurring post-baseline value) \<60 and \>100.
Time frame: Maximum up to 212.28 weeks (maximum exposure was of 208 weeks)
Number of Participants With a New Clinically Significant Ventricular or Atrial Arrhythmias
Arrhythmia assessment: incidence of new and clinically significant ventricular or atrial arrhythmias was assessed by an implantable cardioverter defibrillator (ICD) or CRT defibrillator (CRT-D) applicable device interrogations.
Time frame: Baseline, Week 12, Week 24
A total of 77 participants with Lamin A/C protein (LMNA)-related dilated cardiomyopathy (DCM) in New York heart association (NYHA) functional Class II and III were enrolled in the study. All participants enrolled received at least 1 dose of study intervention.
| Milestone | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Started | 40 | 37 |
| Completed | 0 | 0 |
| Not completed | 40 | 37 |
| Withdrew: Other | 4 | 1 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Study termination by sponsor | 29 | 32 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Death | 1 | 2 |
| Milestone | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional. Study discontinuation \& death were incorporated into endpoint definition through ranking in hypothesis testing of treatment difference. Missing data resulting from study discontinuation were imputed using control-based multiple imputation method to estimate treatment effect.
| Meter | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Baseline | 402.500 (348.195 to 444.000) | 393.935 (360.000 to 425.500) |
| Week 24 | 420.234 (358.902 to 459.117) | 393.455 (347.409 to 450.826) |
| Week 24 change from baseline | 20.996 (-22.757 to 51.477) | 2.679 (-11.530 to 33.698) |
The 6 MWT was an assessment where the distance that a participant could walk on a flat and hard surface in 6 minutes was measured. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed, and under supervision of a qualified professional.
| Meter | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Change at Week 4 | 15.40 (-72.0 to 71.8) | -2.60 (-85.0 to 34.5) |
| Change at Week 12 | 21.47 (-70.2 to 69.3) | 10.00 (-100.9 to 89.5) |
The KCCQ measured the effects of symptoms, functional (physical) limitations, and psychological distress on an individual's health-related quality of life. It contains 23 items, which assessed the ability to perform activities of daily living, frequency and severity of symptoms, the impact of these symptoms, and health-related quality of life. PL was a single questionnaire with score range of 0 to 100, where higher scores reflected better physical functioning status. TSS included frequency and severity of symptoms, and the impact of these symptoms. TSS scores were transformed to a range of 0 to 100, where higher scores reflected better health status.
| Units on a scale | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Week 12 Physical Limitation (PL) | 4.48 ± 11.373 | -1.17 ± 15.326 |
| Week 24 Physical Limitation (PL) | 2.98 ± 17.510 | 1.21 ± 14.104 |
| Week 12 Total Symptom Score (TSS) | 3.66 ± 12.487 | 1.04 ± 16.491 |
| Week 24 Total Symptom Score (TSS) | 4.02 ± 19.171 | -0.94 ± 14.981 |
PGI-S is a global index that rate the severity of the disease using a 5-point scale. In this outcome the number of participants with improvements in PGI-S the severity of their heart failure symptoms and in the severity of their PL were reported. Measured by the scale of: none, mild, moderate, severe or very severe (listed from better to worse).
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Week 12: Severity of heart failure symptoms — None | 4 | 5 |
| Week 12: Severity of heart failure symptoms — Mild | 16 | 14 |
| Week 12: Severity of heart failure symptoms — Moderate | 8 | 10 |
| Week 12: Severity of heart failure symptoms — Severe | 4 | 2 |
| Week 12: Severity of heart failure symptoms — Very Severe | 1 | 1 |
| Week 24: Severity of heart failure symptoms — None | 4 | 6 |
| Week 24: Severity of heart failure symptoms — Mild | 11 | 10 |
| Week 24: Severity of heart failure symptoms — Moderate | 10 | 12 |
| Week 24: Severity of heart failure symptoms — Severe | 3 | 3 |
| Week 24: Severity of heart failure symptoms — Very Severe | 0 | 0 |
| Week 12: Severity of physical activity limitations — None | 6 | 7 |
| Week 12: Severity of physical activity limitations — Mild | 11 | 5 |
| Week 12: Severity of physical activity limitations — Moderate | 12 | 15 |
| Week 12: Severity of physical activity limitations — Severe | 3 | 4 |
| Week 12: Severity of physical activity limitations — Very Severe | 1 | 1 |
| Week 24: Severity of physical activity limitations — None | 6 | 6 |
| Week 24: Severity of physical activity limitations — Mild | 5 | 7 |
| Week 24: Severity of physical activity limitations — Moderate | 13 | 15 |
| Week 24: Severity of physical activity limitations — Severe | 4 | 3 |
| Week 24: Severity of physical activity limitations — Very Severe | 0 | 0 |
PGI-C is a global index that rate the severity of the disease using a 7-point scale. In this outcome the number participants with improvements in their heart failure symptoms and "in their physical activity limitations?", were reported. Measured by the scale of: very much better, moderately better, a little better, no change, a little worse, moderately worse, very much worse (listed from better to worse).
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Week 12: Overall change in heart failure symptoms — Very Much Better | 0 | 2 |
| Week 12: Overall change in heart failure symptoms — Moderately Better | 3 | 1 |
| Week 12: Overall change in heart failure symptoms — A Little Better | 7 | 9 |
| Week 12: Overall change in heart failure symptoms — No Change | 18 | 17 |
| Week 12: Overall change in heart failure symptoms — A Little Worse | 3 | 1 |
| Week 12: Overall change in heart failure symptoms — Moderately Worse | 1 | 0 |
| Week 12: Overall change in heart failure symptoms — Very Much Worse | 1 | 2 |
| Week 24: Overall change in heart failure symptoms — Very Much Better | 1 | 1 |
| Week 24: Overall change in heart failure symptoms — Moderately Better | 3 | 2 |
| Week 24: Overall change in heart failure symptoms — A Little Better | 7 | 6 |
| Week 24: Overall change in heart failure symptoms — No Change | 16 | 16 |
| Week 24: Overall change in heart failure symptoms — A Little Worse | 0 | 2 |
| Week 24: Overall change in heart failure symptoms — Moderately Worse | 1 | 1 |
| Week 24: Overall change in heart failure symptoms — Very Much Worse | 0 | 1 |
| Week 12: Overall change in physical activity limitations — Very Much Better | 0 | 1 |
| Week 12: Overall change in physical activity limitations — Moderately Better | 3 | 2 |
| Week 12: Overall change in physical activity limitations — A Little Better | 3 | 5 |
| Week 12: Overall change in physical activity limitations — No Change | 24 | 21 |
| Week 12: Overall change in physical activity limitations — A Little Worse | 0 | 1 |
| Week 12: Overall change in physical activity limitations — Moderately Worse | 3 | 1 |
| Week 12: Overall change in physical activity limitations — Very Much Worse | 0 | 1 |
| Week 24: Overall change in physical activity limitations — Very Much Better | 1 | 1 |
| Week 24: Overall change in physical activity limitations — Moderately Better | 3 | 0 |
| Week 24: Overall change in physical activity limitations — A Little Better | 3 | 4 |
| Week 24: Overall change in physical activity limitations — No Change | 19 | 20 |
| Week 24: Overall change in physical activity limitations — A Little Worse | 1 | 3 |
| Week 24: Overall change in physical activity limitations — Moderately Worse | 1 | 1 |
| Week 24: Overall change in physical activity limitations — Very Much Worse | 0 | 0 |
NT pro-BNP is a cardiac biomarker that is released in the blood in response to changes in the pressure inside of the heart. Levels go up when heart failure develops or gets worse, and levels go down when heart failure is stable or improves. This biomarker helps to measure the changes in the severity of heart failure over time in response to therapy.
| picomoles per liter | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Change at Week 4 | -43.89 ± 65.465 | -3.07 ± 62.745 |
| Change at Week 12 | -36.40 ± 69.228 | -0.70 ± 54.870 |
| Change at Week 24 | 5.00 ± 236.643 | 24.37 ± 134.225 |
Defined as the time from randomization to the first occurrence of any event of death due to any cause, or worsening heart failure (HF-related hospitalization or HF-related urgent care visit). Kaplan-Meier method and cox regression model were used for analysis.
| Weeks | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Composite Time to First Occurrence of All-Cause Mortality or Worsening Heart Failure (WHF) | NA (NA to NA) | NA (NA to NA) |
OS was defined as time from randomization to death due to any cause. Participants who did not have a death date were censored for OS at their last contact date. Kaplan-Meier method and cox regression model were used for analysis.
| Weeks | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent AEs were events that occurred between first dose of study drug and up to 30 days after last dose. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all Non-SAEs. Grade \>=3 AEs meant severe AEs.
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Participants with TEAEs | 35 | 34 |
| Participants with serious TEAEs | 10 | 21 |
| Participants with severe (Grades >=3) TEAEs | 16 | 20 |
Following parameters were analyzed for laboratory examination: hematology (eosinophils, erythrocytes, hemoglobin, hematocrit, granulocytes, leukocytes, lymphocytes, monocytes, platelets, neutrophils, nucleated erythrocytes); blood chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, blood urea nitrogen, C-reactive protein, calcium, chloride, creatinine, creatine kinase, epidermal growth factor receptor, follicle stimulating hormone, gamma glutamyl transferase, glucose, magnesium, N-Terminal ProB-type natriuretic peptide, phosphate, potassium, protein, sodium, potassium, thyrotropin, troponin I, troponin T, urate).
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Eosinophils: High (>0.8) 10^9/L | 1 | 0 |
| Eosinophils/Leukocytes: High (>7) % | 1 | 1 |
| Erythrocyte Mean Corpuscular Hemoglobin Concentration: Low (<310) g/L | 30 | 29 |
| Erythrocyte Mean Corpuscular Hemoglobin: Low (<27) pg | 6 | 3 |
| Erythrocyte Mean Corpuscular Hemoglobin: High (>34) pg | 0 | 1 |
| Erythrocyte Mean Corpuscular Volume: Low (Males <78, Females <82) | 2 | 2 |
| Erythrocyte Mean Corpuscular Volume: High (Males >100, Females >102) | 10 | 15 |
| Erythrocytes: Low (Males: < 4.63, Females: <3.7) 10^12/L | 14 | 16 |
| Erythrocytes: High (Males: > 6.08, Females: > 5.2) 10^12/L | 4 | 4 |
| Erythrocytes Distribution Width: High (>14.5) % | 22 | 20 |
| Hematocrit: Low (Males: <0.37, Females: <0.33) L/L | 1 | 3 |
| Hematocrit: High (Males: >0.51, Females: >0.47) L/L | 12 | 15 |
| Hemoglobin: Low (Males: < 125; Females: <110) g/L | 7 | 5 |
| Hemoglobin: High (Males: > 170; Females: > 155) g/L | 5 | 4 |
| Immature Granulocytes: High (> 0.07) 10^9/L | 9 | 7 |
| Immature Granulocytes/Leukocytes: High (> 1) % | 6 | 6 |
| Leukocytes: Low (< 3.7) 10^9/L | 1 | 0 |
| Leukocytes: High (> 11) 10^9/L | 9 | 8 |
| Lymphocytes: Low (< 0.9) 10^9/L | 3 | 4 |
| Lymphocytes: Low (> 3.6) 10^9/L | 4 | 2 |
| Lymphocytes/Leukocytes: Low (< 12) % | 3 | 3 |
| Lymphocytes/Leukocytes: High (> 46) % | 2 | 1 |
| Mean Platelet Volume: Low (< 9.6) fL | 5 | 0 |
| Mean Platelet Volume: High (> 13.8) fL | 3 | 3 |
| Monocytes: High (> 1.2) 10^9/L | 1 | 1 |
| Monocytes/Leukocytes: High (>11) % | 11 | 10 |
| Neutrophils: LOW (< 1.7) 10^9/L | 1 | 1 |
| Neutrophils: HIGH (> 7.9) 10^9/L | 8 | 5 |
| Neutrophils/Leukocytes: HIGH (> 71) % | 16 | 17 |
| Nucleated Erythrocytes: HIGH (> 0.01) 10^9/L | 6 | 1 |
| Nucleated Erythrocytes/Leukocytes: HIGH (> 0.2) % | 6 | 1 |
| Platelets: LOW (< 163) 10^9/L | 13 | 11 |
| Platelets: HIGH (> 375) 10^9/L | 2 | 1 |
| Alanine Aminotransferase: LOW (< 10) U/L | 4 | 5 |
| Alanine Aminotransferase: HIGH (Males: > 40; Females: > 33) U/L | 18 | 17 |
| Albumin: LOW (< 35) g/L | 1 | 0 |
| Alkaline Phosphatase: LOW (Males: < 43; Females: <30) U/L | 3 | 5 |
| Alkaline Phosphatase: HIGH (> 115) U/L | 4 | 5 |
| Aspartate Aminotransferase: HIGH (Males: > 43; Females: > 36) U/L | 11 | 8 |
| Bicarbonate: LOW (< 21) mmol/L | 9 | 12 |
| Bicarbonate: HIGH (> 33) mmol/L | 0 | 1 |
| Bilirubin: HIGH (> 18.8) mcmol/L | 4 | 12 |
| Blood Urea Nitrogen: HIGH (> 7.14) mmol/L | 28 | 27 |
| C Reactive Protein: HIGH (> 47.6) nmol/L | 20 | 19 |
| Calcium: LOW (< 2.12) mmol/L | 0 | 1 |
| Calcium: HIGH (> 2.62) mmol/L | 0 | 1 |
| Chloride: LOW (< 95) mmol/L | 2 | 1 |
| Creatine Kinase: LOW (< 24) U/L | 0 | 2 |
| Creatine Kinase: HIGH (Males: > 207; Females: > 169) U/L | 20 | 12 |
| Creatinine: LOW (< 62) mcmol/L | 14 | 13 |
| Creatinine: HIGH (> 124) mcmol/L | 4 | 6 |
| Creatinine Clearance: LOW (Males: < 85; Females: <75) mL/min | 9 | 8 |
| Creatinine Clearance: HIGH (Males: > 125; Females: > 115) mL/min | 16 | 14 |
| Direct Bilirubin: HIGH (> 6.8) mcmol/L | 4 | 8 |
| Epidermal Growth Factor Receptor: LOW (Males: < 60) mL/min/1.73m2 | 1 | 0 |
| Follicle Stimulating Hormone: HIGH (Males: > 12.4; Females: > 21.5) IU/L | 2 | 4 |
| Gamma Glutamyl Transferase: LOW (Males: < 10; Females: <5) U/L | 1 | 0 |
| Gamma Glutamyl Transferase: HIGH (Males: > 49; Females: > 32) U/L | 15 | 27 |
| Glucose: LOW (Males < 3.94, Females < 3.33) mmol/L | 4 | 4 |
| Glucose: HIGH (Males > 7.66, Females > 6.38) mmol/L | 10 | 10 |
| Magnesium: HIGH (> 1.05) mmol/L | 1 | 1 |
| N-Terminal ProB-type Natriuretic Peptide: HIGH (> 14.63) pmol/L | 40 | 37 |
| Phosphate: LOW (< 0.81) mmol/L | 6 | 6 |
| Phosphate: HIGH (> 1.45) mmol/L | 8 | 4 |
| Potassium: LOW (< 3.5) mmol/L | 1 | 0 |
| Potassium: HIGH (> 5) mmol/L | 7 | 16 |
| Protein: LOW (< 60) g/L | 2 | 3 |
| Protein: High (> 80) g/L | 2 | 3 |
| Sodium: HIGH (> 145) mmol/L | 1 | 1 |
| Thyrotropin: LOW (< 0.27) mIU/L | 1 | 1 |
| Thyrotropin: HIGH (> 4.2) mIU/L | 5 | 5 |
| Troponin I: HIGH (> 0.3) mcg/L | 4 | 6 |
| Troponin T: HIGH (> 14) ng/L | 36 | 34 |
| Urate: LOW (Males: < 0.238; Females: <0.119) mmol/L | 3 | 2 |
| Urate: HIGH (Males: > 0.476; Females: > 0.357) mmol/L | 9 | 17 |
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, heart rate, and body weight. Vital sign abnormalities criteria included: a) systolic blood pressure (mmHg): decrease (change \<= -20, or value \<90) and increase (change \>=20, or value \>140); b) diastolic blood pressure (mmHg): decrease (change \<= -15, or value \<60) and increase (change \>=15, or value \>90); c) heart Rate (bpm) decrease: (change \<= -15, or value \<50) and increase (change \>=15, or value \>100); d) weight: (kg) decrease (Change \<= -7%) and increase (Change \> =7%).
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Systolic Blood Pressure (mmHg): Decrease | 22 | 17 |
| Systolic Blood Pressure (mmHg): Increase | 6 | 14 |
| Diastolic Blood Pressure (mmHg): Decrease | 28 | 22 |
| Diastolic Blood Pressure (mmHg): Increase | 7 | 18 |
| Heart Rate (bpm): Decrease | 7 | 9 |
| Heart Rate (bpm): Increase | 15 | 10 |
| Weight (kg): Decrease | 10 | 7 |
| Weight (kg): Increase | 5 | 1 |
Following parameters were analyzed: heart rate, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, and Fridericia's correction (QTcF) interval. Criteria for notable ECG values were as follows: QT interval (in millisecond \[msec\]) new (newly occurring post-baseline value) greater than (\>) 450, 480, 500, increase from baseline \>30, increase from baseline \>60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) \> 450, 480, 500, increase from baseline \>30, increase from baseline \>60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) \> 450, 480, 500, increase from baseline \>30, increase from baseline \>60; heart rate in bpm new (newly occurring post-baseline value) \<60 and \>100.
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| QTcB (msec): New >450 | 5 | 4 |
| QTcB (msec): New >480 | 10 | 4 |
| QTcB (msec): New >500 | 11 | 2 |
| QTcB (msec): Increase from baseline >30 | 12 | 4 |
| QTcB (msec): Increase from baseline >60 | 5 | 1 |
| QTcF (msec): New >450 | 7 | 2 |
| QTcF (msec): New >480 | 9 | 3 |
| QTcF (msec): New >500 | 8 | 4 |
| QTcF (msec): Increase from baseline >30 | 11 | 4 |
| QTcF (msec): Increase from baseline >60 | 3 | 0 |
| QT (msec): New >450 | 5 | 4 |
| QT (msec): New >480 | 11 | 1 |
| QT (msec): New >500 | 2 | 1 |
| QT (msec): Increase from baseline >30 | 8 | 3 |
| QT (msec): Increase from baseline >60 | 2 | 0 |
| Heart rate (bpm): New <60 | 1 | 0 |
Arrhythmia assessment: incidence of new and clinically significant ventricular or atrial arrhythmias was assessed by an implantable cardioverter defibrillator (ICD) or CRT defibrillator (CRT-D) applicable device interrogations.
| Participants | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Baseline: Clinically significant atrial arrhythmia | 0 | 0 |
| Week 12: Clinically significant atrial arrhythmia | 0 | 2 |
| Week 24: Clinically significant atrial arrhythmia | 0 | 0 |
| Baseline: Clinically significant ventricular arrhythmia | 0 | 0 |
| Week 12: Clinically significant ventricular arrhythmia | 0 | 3 |
| Week 24: Clinically significant ventricular arrhythmia | 0 | 0 |
Collected over Baseline (Day1) up to a maximum of 208 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-07265803 (ARRY-371797) | 3/40 (7.5%) | 10/40 (25%) | 31/40 (77.5%) |
| Placebo | 3/37 (8.1%) | 21/37 (56.8%) | 27/37 (73%) |
| Event | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| Ventricular tachycardiaCardiac disorders | 5/40 | 5/37 |
| Cardiac failureCardiac disorders | 0/40 | 3/37 |
| Ventricular fibrillationCardiac disorders | 2/40 | 3/37 |
| Atrial fibrillationCardiac disorders | 1/40 | 2/37 |
| Cardiac failure acuteCardiac disorders | 1/40 | 2/37 |
| Acute myocardial infarctionCardiac disorders | 0/40 | 1/37 |
| Atrial flutterCardiac disorders | 1/40 | 1/37 |
| Cardiac failure congestiveCardiac disorders | 0/40 | 1/37 |
| Cardiogenic shockCardiac disorders | 0/40 | 1/37 |
| Mitral valve incompetenceCardiac disorders | 0/40 | 1/37 |
| Event | PF-07265803 (ARRY-371797) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 12/40 | 4/37 |
| SARS-CoV-2 test positiveInvestigations | 11/40 | 7/37 |
| DizzinessNervous system disorders | 9/40 | 4/37 |
| Ventricular tachycardiaCardiac disorders | 7/40 | 8/37 |
| NauseaGastrointestinal disorders | 7/40 | 5/37 |
| HeadacheNervous system disorders | 4/40 | 6/37 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/40 | 6/37 |
| Atrial fibrillationCardiac disorders | 6/40 | 5/37 |
| StomatitisGastrointestinal disorders | 5/40 | 0/37 |
| DermatitisSkin and subcutaneous tissue disorders | 5/40 | 1/37 |
The full analysis set (FAS) consisted of all randomized participants.
| Age, Customized(Participants) | PF-07265803 (ARRY-371797) | Placebo | Total |
|---|---|---|---|
| 18-34 years | 4 | 1 | 5 |
| 35-49 years | 15 | 10 | 25 |
| 50-64 years | 17 | 19 | 36 |
| >= 65 years | 4 | 7 | 11 |
| Sex: Female, Male(Participants) | PF-07265803 (ARRY-371797) | Placebo | Total |
|---|---|---|---|
| Female | 18 | 15 | 33 |
| Male | 22 | 22 | 44 |
| Ethnicity (NIH/OMB)(Participants) | PF-07265803 (ARRY-371797) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 37 | 33 | 70 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PF-07265803 (ARRY-371797) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 38 | 36 | 74 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Showing the first 100 of 107 sites across 10 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Apr 2018 to primary completion in Oct 2022, 53 months.
Results were first posted in Jan 2024, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.