Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

Cytokinetics

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Omecamtiv Mecarbil; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02929329

2016-002299-28 (EudraCT Number)

20110203

Details and patient eligibility

About

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Full description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Enrollment: 8,256 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject has provided informed consent
• Male or female, ≥ 18 to ≤ 85 years
• History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
• Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
• New York Heart Association (NYHA) class II to IV at most recent screening assessment.
• Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
• Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
• Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Other Inclusion Criteria May apply

Key Exclusion Criteria:

• Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
• Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8,256 participants in 2 patient groups, including a placebo group

Omecamtiv Mecarbil

Experimental group

Description:

Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations \< 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and \< 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and \< 1000 ng/mL maintained a 25 mg BID dosing regimen.

Treatment:

Drug: Omecamtiv Mecarbil

Drug: Standard of Care

Placebo

Placebo Comparator group

Description:

Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.

Treatment:

Drug: Placebo

Drug: Standard of Care