Financiado en parte por Merck, Merck Sharp and Dohme LLC
A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide
Navar AM, Mikhailova E, Catapano AL, Banka P, Blom DJ, Cadena A, Kourpanidis S, Lepor NE, Tsukamoto K, Mendizabal G, Nunez J, Zhang W, Zhu P, Zhuo M, Ballantyne CM, CORALreef Lipids Investigators
The New England journal of medicine · 34 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Merck
- Empresa
- Merck Sharp and Dohme LLC
Según 2 financiadores declarados.
Publicación
- Publicado
- 2026-02-04 · N Engl J Med · vol. 394 · número 6 · págs. 529–539
- Editorial
- Massachusetts Medical Society
- Citado
- 52 citas · más que el 100% de estudios similares · 326.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 22 trabajos
- Acceso
- De pago
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Lipid metabolism and disorders · Cholesterol and Lipid Metabolism
- Palabras clave
- PCSK9 inhibitors, LDL cholesterol lowering, atherosclerotic cardiovascular disease, hypercholesterolemia, non-HDL cholesterol, apolipoprotein B, lipoprotein(a), cardiovascular risk reduction, long-term safety, adverse events, drug discontinuation, tolerability
- MeSH
- humans, cardiovascular diseases, hypercholesterolemia, aza compounds, triazoles, pyrrolidines, lipoprotein(a), apolipoproteins b, treatment outcome, administration, oral, double-blind method, aged, middle aged, female, male, atherosclerosis, cholesterol, ldl, pcsk9 inhibitors
15 autores
- Ann Marie Navar🇺🇸The University of Texas Southwestern Medical Center
- Elina Mikhailova🇬🇧MSD (UK) Limited (United Kingdom)
- Alberico Luigi Catapano🇮🇹University of Milan; MultiMedica
- Puja Banka🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Dirk Jacobus Blom🇿🇦University of Cape Town
- Alberto Cadena
- Susan Kourpanidis🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Norman E. Lepor🇺🇸Cedars-Sinai Smidt Heart Institute
- Kazuhisa Tsukamoto🇯🇵Teikyo University
- Geraldine Mendizabal
- Julio Nunez🇪🇸Universitat de València
- Wenjuan Zhang🇨🇳MSD (China) Investment Co., Ltd. (China)
- Pengfei Zhu🇨🇳MSD (China) Investment Co., Ltd. (China)
- Min Zhuo🇺🇸Merck & Co., Inc., Rahway, NJ, USA (United States)
- Christie M. Ballantyne🇺🇸Baylor College of Medicine
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Enlicitide decanoate, an oral proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, was shown to reduce low-density lipoprotein (LDL) cholesterol levels in a phase 2 trial; longer-term data are needed.
Methods
In this multinational, double-blind, randomized, placebo-controlled trial, we enrolled adults with a history of a major atherosclerotic cardiovascular disease event with an LDL cholesterol level of 55 mg per deciliter or higher and those who were at risk for a first atherosclerotic cardiovascular disease event with an LDL cholesterol level of 70 mg per deciliter or higher. Participants were assigned in a 2:1 ratio to receive enlicitide at a dose of 20 mg or placebo daily for 52 weeks. The primary end point was the mean percent change in LDL cholesterol level from baseline to week 24. Key secondary end points were the mean percent change in LDL cholesterol level at week 52 and the mean percent change in levels of non-high-density lipoprotein (non-HDL) cholesterol and apolipoprotein B and the percent change in lipoprotein(a) level at week 24.
Results
Of the 2909 participants in the intention-to-treat population, 1935 received enlicitide and 969 received placebo (5 did not receive enlicitide or placebo). The mean age of the participants was 63 years, and 39.3% were women. The mean (±SD) LDL cholesterol level at baseline was 96.1±38.9 mg per deciliter. The mean percent change in LDL cholesterol levels at week 24 was -57.1% (95% confidence interval [CI], -61.8 to -52.5) with enlicitide and 3.0% (95% CI, 0.9 to 5.1) with placebo, representing an adjusted between-group difference of -55.8 percentage points (95% CI, -60.9 to -50.7; P<0.001). The mean percent change in LDL cholesterol level at week 52, the mean percent changes in non-HDL cholesterol and apolipoprotein B levels at week 24, and the percent change in lipoprotein(a) levels at week 24 were significantly greater with enlicitide than with placebo (P<0.001 for all comparisons). The incidence of adverse events did not appear to differ between the groups.
Conclusions
Among participants who had a history of or were at risk for a first atherosclerotic cardiovascular disease event, treatment with the oral PCSK9 inhibitor enlicitide resulted in significantly lower LDL cholesterol levels than placebo at 24 weeks. (Funded by MSD [Rahway, NJ]; CORALreef Lipids ClinicalTrials.gov number, NCT05952856.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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