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Clinical Trials

The safety, tolerability, pharmacokinetics, and pharmacodynamics of omecamtiv mecarbil have been studied across eleven Phase 1 clinical trials, which enrolled over 300 healthy subjects. In addition, seven Phase 2 clinical trials have enrolled more than 1,400 people with heart failure. Omecamtiv mecarbil is currently the subject of a Phase 3 clinical trials program. Recent trials include:

METEORIC-HF – METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. This trial is being conducted by Cytokinetics in collaboration with Amgen and Servier, and is designed to enroll approximately 270 patients with HFrEF at sites throughout the U.S., Canada and Europe. For more information about this trial, click here.
GALACTIC-HF GALACTIC-HF is a Phase 3, double-blind, placebo-controlled, multicenter clinical trial to be conducted by Amgen in collaboration with Cytokinetics. The trial is evaluating the effect of treatment with omecamtiv mecarbil compared with placebo in approximately 8,200 patients with chronic heart failure with reduced ejection fraction receiving standard of care therapy.The primary endpoint is time to cardiovascular death or first heart failure event, whichever comes first. GALACTIC-HF is being conducted under a Special Protocol Assessment (SPA) with the FDA. For more information about this trial, click here.
COSMIC-HF – Cytokinetics and Amgen announced results from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating oral omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, at the American Heart Association Scientific Sessions in November 2015. COSMIC-HF was a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to evaluate the pharmacokinetics and tolerability of orally-administered omecamtiv mecarbil in approximately 450 patients.
ATOMIC-AHF – Cytokinetics and Amgen announced results from ATOMIC-AHF (A Trial of Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure), a Phase 2b trial evaluating omecamtiv mecarbil in acutely ill, hospitalized heart failure patients, at the European Society of Cardiology (ESC) Congress and the Heart Failure Society of America (HFSA) Annual Meeting, both in September 2013. This clinical trial was an international, multicenter, randomized, double-blind, placebo-controlled study in approximately 600 patients, enrolled in three sequential, ascending-dose cohorts. In each cohort, patients were randomized to receive omecamtiv mecarbil or placebo.

Reldesemtiv has been the subject of five Phase 1 clinical trials in healthy volunteers evaluating its safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics. Cytokinetics and Astellas announced results from a hypothesis-generating Phase 2 clinical study of reldesemtiv in 70 patients with Type II, Type III and Type IV spinal muscular atrophy (SMA) at the Annual Cure SMA Conference in June 2018. The study showed statistically significant concentration-dependent increases in changes from baseline in Six Minute Walk Distance (6MWD), a sub-maximal exercise test of aerobic capacity and endurance. The study also showed statistically significant increases for Maximal Expiratory Pressure (MEP), a measure of strength of respiratory muscles. Adverse events were similar between groups receiving reldesemtiv and placebo. For more information about the trial, click here.

FORTITUDE-ALS – Cytokinetics announced results from FORTITUDE-ALS, a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in patients with ALS at the American Academy of Neurology meeting in May 2019. The trial enrolled 458 patients with ALS in the US, Canada, Europe and Australia. The trial did not achieve statistical significance for its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing, but all patients on all doses of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with clinically meaningful differences emerging over time. For more information about the trial, click here.

CK-274 was the subject of a Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose study was to assess the safety and tolerability of CK-274 in healthy volunteers. The study demonstrated that CK-274 was safe and well tolerated in healthy participants. No serious adverse events and no clinically meaningful changes in vital signs, ECGs or laboratory tests were observed. Stopping criteria for continued dose escalation were reached after a single dose of 75 mg and after 14 days of a daily of 10 mg dose. Decreases in ejection fraction below 50% were readily reversible within six hours following single doses and within 24-48 hours following 14 days of dosing. The pharmacokinetics of CK-274 were generally dose linear, and steady-state appeared evident within 14 days of dosing. Left ventricular ejection fraction decreased in an exposure dependent manner and the PK/PD relationship for CK-274 observed in humans was similar to that observed preclinically when adjusted for differences in protein binding. Specifically, the shallow exposure-response relationship observed preclinically appears to translate to humans and thereby may enable flexible dose optimization in humans. For more information about the trial, click here.