A Phase 2 interventional study of IW-1973 and Placebo Oral Tablet in Heart Failure With Preserved Ejection Fraction, sponsored by Akebia Therapeutics. Completed at 62 sites in 2 countries. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Akebia Therapeutics · Phase 2, Interventional, and Treatment
The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 196 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Akebia Therapeutics is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
Patient meets at least 2 of the following criteria at the Screening Visit:
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IW-1973
Placebo to match experimental drug
Drug: Placebo Oral Tablet
Oral Tablet
Oral Tablet
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Study Drug-related TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is presented.
Time frame: Day 1 up to Day 113
Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12
Peak VO2 was obtained from Cardiopulmonary Exercise Test (CPET), which was used to evaluate the effect of praliciguat on peak exercise capacity. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an analysis of covariance (ANCOVA) model with treatment group and atrial fibrillation stratification factors as categorical variable terms and Baseline peak VO2 value as a covariate. Milliliter O2 per kilogram per minute = mL O2/kg/min
Time frame: Baseline and Week 12
Change From Baseline in 6-minute Walk Test (6MWT) Distance at Week 12
6MWT was a simple assessment of everyday functional capacity and provided a global evaluation of the organ/physiologic systems involved in exercise. 6MWT assessed the distance travelled in 6 minutes, measured at approximately the same time of day. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and Baseline value as a covariate.
Time frame: Baseline and Week 12
Change From Baseline in Ventilatory Efficiency at Week 12
Ventilatory efficiency was defined as minute ventilation/carbon dioxide (VE/VCO2) slope, production and was obtained from CPET. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and baseline value as a covariate.
Time frame: Baseline and Week 12
CPET Responders at Week 12
CPET responders were defined as participants who improved by at least 1.5 mL O2/kg/min in peak VO2 from Baseline to Week 12. Baseline is defined as the last non-missing measurement prior to the first dose of study drug.
Time frame: At Week 12
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of different doses of praliciguat (IW-1973) compared with placebo in participants with heart failure with preserved ejection fraction (HFpEF).
| Milestone | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg |
|---|---|---|---|---|
| Started | 90 | 7 | 7 | 92 |
| Completed | 78 | 7 | 7 | 77 |
| Not completed | 12 | 0 | 0 | 15 |
| Withdrew: Adverse event | 3 | 0 | 0 | 6 |
| Withdrew: Protocol violation | 6 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 4 |
| Withdrew: Death | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 2 |
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those adverse events (AEs) that started or worsened in severity after the administration of study drug. Causality relationship to study drug was per Investigator assessment. Number of participants with TEAEs and study drug-related TEAEs is presented.
| Participants | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg |
|---|---|---|---|---|
| TEAEs | 61 | 4 | 6 | 72 |
| Study drug-related TEAEs | 9 | 1 | 0 | 22 |
Peak VO2 was obtained from Cardiopulmonary Exercise Test (CPET), which was used to evaluate the effect of praliciguat on peak exercise capacity. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an analysis of covariance (ANCOVA) model with treatment group and atrial fibrillation stratification factors as categorical variable terms and Baseline peak VO2 value as a covariate. Milliliter O2 per kilogram per minute = mL O2/kg/min
| mL O2/kg/min | Placebo | Praliciguat 40 mg |
|---|---|---|
| Change From Baseline in Peak Oxygen Consumption (VO2) at Week 12 | 0.04 (-0.49 to 0.56) | -0.26 (-0.83 to 0.31) |
6MWT was a simple assessment of everyday functional capacity and provided a global evaluation of the organ/physiologic systems involved in exercise. 6MWT assessed the distance travelled in 6 minutes, measured at approximately the same time of day. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and Baseline value as a covariate.
| Meters | Placebo | Praliciguat 40 mg |
|---|---|---|
| Change From Baseline in 6-minute Walk Test (6MWT) Distance at Week 12 | 58.12 (26.12 to 90.11) | 41.38 (8.25 to 74.50) |
Ventilatory efficiency was defined as minute ventilation/carbon dioxide (VE/VCO2) slope, production and was obtained from CPET. Baseline is defined as the last non-missing measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the Week 12 value. Data were analyzed using an ANCOVA model with treatment group, atrial fibrillation stratification factor and peak VO2 stratification factor as categorical variable terms and baseline value as a covariate.
| VE/VCO2 Slope | Placebo | Praliciguat 40 mg |
|---|---|---|
| Change From Baseline in Ventilatory Efficiency at Week 12 | 0.564 (-0.780 to 1.908) | 0.267 (-1.118 to 1.652) |
CPET responders were defined as participants who improved by at least 1.5 mL O2/kg/min in peak VO2 from Baseline to Week 12. Baseline is defined as the last non-missing measurement prior to the first dose of study drug.
| Participants | Placebo | Praliciguat 40 mg |
|---|---|---|
| CPET Responders at Week 12 | 17 | 13 |
Collected over From first dose of study drug (Day 1) up to Follow-up Visit (Day 113). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/90 (0%) | 9/90 (10%) | 58/90 (64.4%) |
| Praliciguat 10 mg | 0/7 (0%) | 0/7 (0%) | 4/7 (57.1%) |
| Praliciguat 20 mg | 0/7 (0%) | 0/7 (0%) | 6/7 (85.7%) |
| Praliciguat 40 mg | 1/91 (1.1%) | 10/91 (11%) | 68/91 (74.7%) |
| Event | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg |
|---|---|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/90 | 0/7 | 0/7 | 0/91 |
| Non-cardiac chest painGeneral disorders | 2/90 | 0/7 | 0/7 | 0/91 |
| Atrial fibrillationCardiac disorders | 1/90 | 0/7 | 0/7 | 1/91 |
| Cardiac failure acuteCardiac disorders | 1/90 | 0/7 | 0/7 | 1/91 |
| PneumoniaInfections and infestations | 1/90 | 0/7 | 0/7 | 1/91 |
| AnaemiaBlood and lymphatic system disorders | 1/90 | 0/7 | 0/7 | 0/91 |
| Angina pectorisCardiac disorders | 1/90 | 0/7 | 0/7 | 0/91 |
| Cardiac failureCardiac disorders | 1/90 | 0/7 | 0/7 | 0/91 |
| Chondrocalcinosis pyrophosphateMusculoskeletal and connective tissue disorders | 1/90 | 0/7 | 0/7 | 0/91 |
| Diabetic footSkin and subcutaneous tissue disorders | 1/90 | 0/7 | 0/7 | 0/91 |
| Event | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg |
|---|---|---|---|---|
| Weight increasedInvestigations | 0/90 | 2/7 | 0/7 | 0/91 |
| Angina pectorisCardiac disorders | 0/90 | 1/7 | 0/7 | 2/91 |
| Cardiac failureCardiac disorders | 2/90 | 0/7 | 1/7 | 0/91 |
| GoitreEndocrine disorders | 0/90 | 0/7 | 1/7 | 0/91 |
| Abdominal pain upperGastrointestinal disorders | 0/90 | 1/7 | 0/7 | 0/91 |
| Frequent bowel movementsGastrointestinal disorders | 0/90 | 1/7 | 0/7 | 0/91 |
| FatigueGeneral disorders | 4/90 | 1/7 | 0/7 | 5/91 |
| PyrexiaGeneral disorders | 1/90 | 1/7 | 0/7 | 1/91 |
| ThirstGeneral disorders | 1/90 | 1/7 | 0/7 | 0/91 |
| Urinary tract infectionInfections and infestations | 5/90 | 0/7 | 1/7 | 7/91 |
Intent-To-Treat (ITT) Population: The ITT Population consisted of all randomized participants.
| Age, Continuous(years) | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg | Total |
|---|---|---|---|---|---|
| Mean | 70.1 ± 9.0 | 67.3 ± 9.6 | 69.1 ± 4.6 | 70.8 ± 9.1 | 70.3 ± 8.9 |
| Sex: Female, Male(Participants) | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg | Total |
|---|---|---|---|---|---|
| Female | 40 | 5 | 3 | 35 | 83 |
| Male | 50 | 2 | 4 | 57 | 113 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 20 | 0 | 0 | 20 | 40 |
| Not Hispanic or Latino | 69 | 7 | 7 | 72 | 155 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | Praliciguat 10 mg | Praliciguat 20 mg | Praliciguat 40 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 1 |
| Asian | 1 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 19 | 1 | 2 | 17 | 39 |
| White | 65 | 6 | 5 | 72 | 148 |
| More than one race | 2 | 0 | 0 | 1 | 3 |
| Unknown or Not Reported | 1 | 0 | 0 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Praliciguat