Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Summary
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).
Timeline
- Start
- 2017-01-06
- Primary completion
- 2020-09-14
- Completion
- 2020-09-14
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Omecamtiv Mecarbil; p = 0.0252; Hazard Ratio (HR) 0.92 (95% CI 0.86 to 0.99); Regression, Cox NCT02929329 ↗
release “The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint” cytokinetics.com ↗
release “GALACTIC-HF which demonstrated a positive effect on the primary composite endpoint” cytokinetics.com ↗
release “GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint” cytokinetics.com ↗
release “Positive results from GALACTIC-HF, the first Phase 3 clinical trial of omecamtiv mecarbil demonstrated a statistically significant effect” cytokinetics.com ↗
release “The trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint” cytokinetics.com ↗
release “Positive results from GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint” cytokinetics.com ↗
Publications
- Background Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.
- Ono R, Docherty KF, Henderson AD, Echeverria LE, Felker GM, Lopes RD, Martinez F, Packer M, Ramires FJA, Teerlink JR, Vaduganathan M, Zile MR, Jhund PS, Solomon SD, McMurray JJV. Comparative Prognosis of Chagas and Other Cardiomyopathies. J Am Coll Cardiol. 2026 Jun 30;87(25):3521-3535. doi: 10.1016/j.jacc.2026.03.022. Epub 2026 Mar 16.
- Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Tolomeo P, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Dipstick proteinuria and outcomes in patients with heart failure and reduced ejection fraction: insights from GALACTIC-HF. Eur J Heart Fail. 2026 May 11;28(2):249-259. doi: 10.1093/ejhf/xuag003.
- Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Lactate Dehydrogenase and Outcomes in Patients With HF and Reduced Ejection Fraction: Insights From GALACTIC-HF. JACC Heart Fail. 2026 May;14(5):102900. doi: 10.1016/j.jchf.2025.102900. Epub 2026 Jan 13.
- Lu H, Claggett BL, Felker GM, McMurray JJV, Teerlink JR, Inciardi RM, Metra M, Heitner SB, Diaz R, Malik F, Vaduganathan M, Solomon SD. Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction According to Age: The GALACTIC-HF Trial. JACC Heart Fail. 2026 Feb;14(2):102703. doi: 10.1016/j.jchf.2025.102703. Epub 2025 Oct 22.
- Felker GM, Solomon SD, Metra M, Mcmurray JJV, Diaz R, Claggett B, Lanfear DE, Vandekerckhove H, Biering-Sorensen T, Lopes RD, Arias-Mendoza A, Momomura SI, Corbalan R, Ramires FJA, Zannad F, Heitner SB, Divanji PH, Kupfer S, Malik FI, Teerlink JR. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil: Results From the GALACTIC-HF Study. J Card Fail. 2024 Jun;30(6):755-763. doi: 10.1016/j.cardfail.2023.11.021. Epub 2024 Jan 11.
- Pabon M, Cunningham J, Claggett B, Felker GM, McMurray JJV, Metra M, Diaz R, Wang X, Arias-Mendoza A, Bonderman D, Crespo-Leiro M, Fonseca C, Goncalvesova E, Lund M, O'Meara E, Sliwa-Hahnle K, Malik FI, Solomon SD, Teerlink JR; GALACTIC-HF Investigators. Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial. JACC Heart Fail. 2023 Dec;11(12):1729-1738. doi: 10.1016/j.jchf.2023.07.029. Epub 2023 Oct 11.
- Docherty KF, McMurray JJV, Claggett BL, Miao ZM, Adams KF, Arias-Mendoza A, Cleland JGF, Diaz R, Echeverria Correa LE, Felker GM, Fonseca C, Li J, Metra M, Sliwa-Hahnle K, Solomon SD, Vandekerckhove HJ, Vinereanu D, Voors AA, Heitner SB, Kupfer S, Malik FI, Meng L, Teerlink JR. Efficacy of omecamtiv mecarbil in heart failure with reduced ejection fraction according to N-terminal pro-B-type natriuretic peptide level: insights from the GALACTIC-HF trial. Eur J Heart Fail. 2023 Feb;25(2):248-259. doi: 10.1002/ejhf.2763. Epub 2023 Jan 16.
- Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144.
- Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.
- Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
- Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omecamtiv Mecarbil | Small molecule | 25 mg | Oral |
| Subject | Omecamtiv Mecarbil | Small molecule | 37.5 mg | Oral |
| Subject | Omecamtiv Mecarbil | Small molecule | 50 mg | Oral |