AMBER-HFpEF

Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF

What is heart failure with preserved ejection fraction (HFpEF)?

Heart failure (HF) is an abnormality of cardiac function such that the heart fails to meet the needs of the body or is able to do so only with elevated filling pressures.

There are different types of HF and one way to categorize them is based on left ventricular ejection fraction (LVEF) (the pumping strength of the left ventricle). Heart failure with preserved ejection fraction (HFpEF) is characterized by having an ejection fraction within the normal range (LVEF is greater than or equal to 50%). Typically, patients with HFpEF have hearts that are abnormally thickened and/or have heart muscles that do not normally relax. This places the heart under chronic stress, requiring it to work harder to pump blood to the body.

Patients diagnosed with HFpEF typically have signs and symptoms that can disrupt daily life, such as:

  • Breathlessness
  • Cough
  • Interrupted sleep
  • Exercise intolerance
  • Fatigue
  • Swelling of ankles, legs, abdomen, or veins in the neck

The severity of these symptoms varies between people with HFpEF and can even vary day-to-day.

About AMBER-HFpEF

Clinical trial participation period: Now and ongoing

A clinical research trial

AMBER-HFpEF (Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is a study to compare the safety and tolerability of CK-4021586 (the investigational medicine) versus placebo at increasing dose levels. The purposes of the study are to learn about the safety and how well participants tolerate various doses of CK-4021586 when taken by mouth over time, to learn how the study drug interacts with the body at different doses, and how the body’s heart function responds to CK-4021586.

CK-4021586 is the investigational (experimental) medicine being studied in this trial.

Participants will be randomly assigned to receive either CK-4021586 (the investigational medicine) or placebo (a substance that does not have any medicine in it).

In HFpEF, the heart muscle works harder to pump blood to the body. CK-4021586 may help reduce symptoms of HFpEF by decreasing excess pumping and improving relaxation of the heart muscle.

CK-4021586 is an investigational medicine and is not currently approved for use by regulatory agencies like the FDA – its safety and effectiveness have not been established.

Abbreviated participation criteria

  • 40 to 85 years old
  • Body mass index < 40 kg/m2
  • Diagnosed with HF with New York Heart Association (NYHA) functional class II or III

Additional participation criteria will apply. Further details regarding the participation criteria can be found at https://clinicaltrials.gov/study/NCT06793371.

What is AMBER-HFpEF?

Clinical trial overview

AMBER-HFpEF is a phase 2 clinical trial of CK-4021586 compared to placebo in participants with HFpEF.

The clinical trial will evaluate the safety and tolerability of CK-4021586 compared with placebo by evaluating participant adverse events (side effects) and evaluating participant’s heart structure, function, and performance by looking at the heart with ultrasound. The clinical trial will also evaluate the effect of CK-4021586 on blood tests of cardiac function and on health status and health-related quality of life questionnaires. The safety and tolerability of CK-4021586 at different, increasing dose levels will also be studied. Finally, the study will also measure the amount of CK-4021586 in the participant’s blood at various times and the effect the investigational medicine may have on a participant’s HFpEF.

Clinical trial duration

The clinical trial participation will last about 14 weeks (3.5 months), not including the screening window.

Participants will receive an initial dose of investigational medicine or placebo for 6 weeks (1.5 months). When a participant completes all study tests at Week 6, the participant may (if LVEF is greater than or equal to 50%) receive a higher dose of investigational medicine for the next 6 weeks (1.5 months). Participants may continue treatment with initial investigational medicine dose or be switched to placebo if appropriate. After taking the investigational medicine for 12 weeks, the investigational medicine will be stopped, and participants will return two weeks later for a follow-up visit.

Clinical trial drug

If the study doctor determines a participant is eligible and the participant agrees to participate, they will receive either CK-4021586 or placebo during the treatment period. Placebo is identical in appearance to the investigational medicine but contains no active ingredient. The medication – CK-4021586 or placebo – is taken by mouth daily.

The investigative medicine the participant receives will be determined by chance (i.e., like flipping a coin). The chance of receiving CK-4021586 will be 3 in 4 (75%), and the chance of receiving placebo will be 1 in 4 (25%).

Study medicine doses

Participants who receive CK-4021586 may receive one of four different doses (150, 300, 450, 600 mg). The dose schedule below will be followed according to the group the participant is assigned to participate in. A safety committee will review data prior to opening each subsequent cohort (Cohorts 2 and 3) to ensure it is safe to proceed.

  • Cohort 1: The starting dose will be 150 mg daily and may increase to 300 mg daily at Week 6 (Day 42) depending on how well the participant’s heart pumps the blood.
  • Cohort 2: The starting dose will be 300 mg daily and may increase to 450 mg daily at Week 6 (Day 42) depending on how well the participant’s heart pumps the blood.
  • Cohort 3: The starting dose will be 450 mg daily and may increase to 600 mg daily at Week 6 (Day 42) depending on how well the participant’s heart pumps the blood.

CK-4021586 is an investigational drug and is not currently approved for use by regulatory agencies like the FDA – its safety and effectiveness have not been established.

Clinical Trial Locations

Clinical trial sites for AMBER-HFpEF are recruiting participants across the United States.

Check Eligibility

AMBER HFpEF site locations:

Visit clinicaltrials.gov (NCT06793371) to view contacts & locations.