{"id":4342,"date":"2023-05-11T14:39:53","date_gmt":"2023-05-11T14:39:53","guid":{"rendered":"http:\/\/www.enyopharma.com\/fr\/?page_id=4342"},"modified":"2026-01-19T15:25:43","modified_gmt":"2026-01-19T15:25:43","slug":"essais-cliniques","status":"publish","type":"page","link":"https:\/\/www.enyopharma.com\/fr\/science\/essais-cliniques\/","title":{"rendered":"Essais cliniques"},"content":{"rendered":"<h2>Vonafexor est actuellement en \u00e9valuation dans 3 \u00e9tudes cliniques<\/h2>\n<ul>\n<li><strong>Phase 2 ALPESTRIA-1:<\/strong> Etude d&#8217;innocuit\u00e9 et preuve de concept, d&#8217;escalade de doses fixes de Vonafexor, chez des patients \u00e0 risque de progression du syndrome d&#8217;Alport. <a href=\"https:\/\/www.enyopharma.com\/fr\/syndrome-alport\/\" target=\"_blank\" rel=\"noopener\">En savoir plus sur l&#8217;\u00e9tude clinique ALPESTRIA-1<\/a><\/li>\n<li><strong>Phase 2 MRC avec MASH suspect\u00e9:<\/strong> Vonafexor chez des sujets pr\u00e9sentant une insuffisance r\u00e9nale et une suspicion de st\u00e9atoh\u00e9patite associ\u00e9e \u00e0 un dysfonctionnement m\u00e9tabolique (MASH). <a href=\"https:\/\/www.enyopharma.com\/fr\/patients\/maladies-renales-chroniques\/\" target=\"_blank\" rel=\"noreferrer noopener\">En savoir plus sur l&#8217;\u00e9tude<\/a><\/li>\n<\/ul>\n<h2>Vonafexor a d\u00e9j\u00e0 \u00e9t\u00e9 test\u00e9 dans 9 \u00e9tudes cliniques<\/h2>\n<ul>\n<li><b>Phase 2a LIVIFY<\/b>: Innocuit\u00e9, tol\u00e9rance, pharmacocin\u00e9tique et efficacit\u00e9 de EYP001 chez les patients avec une st\u00e9atose h\u00e9patique non alcoolique (NASH).<br \/>\nR\u00e9sultats : Les r\u00e9sultats de l&#8217;essai clinique de Phase 2a LIVIFY montrent que l&#8217;administration oral quotidienne de Vonafexor, un agoniste du FXR, entra\u00eene \u00e0 court terme une r\u00e9duction de la graisse h\u00e9patique, des enzymes h\u00e9patiques, des biomarqueurs de la fibrose, du poids corporel et de la circonf\u00e9rence abdominale, et une am\u00e9lioration possible de la fonction r\u00e9nale. Un prurit l\u00e9ger et mod\u00e9r\u00e9 (effet secondaire de la classe des agonistes de FXR) et une augmentation du cholest\u00e9rol LDL sont diminu\u00e9s avec des doses plus faibles et en combinaison avec des statines. Ces r\u00e9sultats soutiennent l\u2019exploration d\u2019essais plus longs et plus vastes, dans le but de r\u00e9pondre aux besoins m\u00e9dicaux pour la NASH.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03812029\" target=\"_blank\" rel=\"noopener\"> NCT03812029<\/a> ; <a href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2018-003119-22\" target=\"_blank\" rel=\"noopener\"> EudraCT 2018-003119-22<\/a><br \/>\n<a href=\"https:\/\/www.enyopharma.com\/science\/publications\/\" target=\"_blank\" rel=\"noopener\"> Ratziu et al. (2022) Journal of Hepatology. 78 (3), 479-492.<\/a><\/li>\n<\/ul>\n<p><a href=\"https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2023\/05\/LIVIFY-1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-large wp-image-4527\" src=\"https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2023\/05\/LIVIFY.jpg?resize=700%2C301\" alt=\"Ph2a LIVIFY study\" width=\"700\" height=\"301\" data-recalc-dims=\"1\" \/><\/a><\/p>\n<ul>\n<li><b>Phase 1b, open-label<\/b>: A Phase 1b, open-label multiple dose study to evaluate in healthy and NASH subjects the safety, tolerability, PK and PD of FXR agonist EYP001a.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03976687\" target=\"_blank\" rel=\"noopener\"> NCT03976687<\/a><\/li>\n<li><b>Phase 2a, HBV Na\u00efve patients with Vonafexor + PEG-IFN +\/- Entecavir<\/b>: A Phase 2a open-label study of the oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect in chronic Hepatitis B (CHB) patients in combination with pegylated interferon alpha2a (peg-IFN) alone and with entecavir (ETV).<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04365933\" target=\"_blank\" rel=\"noopener\"> NCT04365933<\/a><\/li>\n<li><b>Phase 2a, HBV Aviraemic patients with Vonafexor on top of NUCs<\/b>: A double-blind randomized controlled study in virologically suppressed chronic Hepatitis B patients on stable chronic NA therapy to assess the rate of functional cure with oral FXR-Agonist EYP001a administered on top of NA.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04465916\" target=\"_blank\" rel=\"noopener\"> NCT04465916<\/a> ; EudraCT 2019-001629-28<\/li>\n<li><b>Phase 1b, part A: HBV EYP001a vs Entecavir; Part B: EYP001 + Peg-IFN<\/b>: A randomized, double-blind, placebo-controlled study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of the FXR-agonist EYP001a in chronically HBV infected subjects.<br \/>\n<a href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03272009\" target=\"_blank\" rel=\"noopener\"> NCT03272009<\/a> ; EudraCT 2017-002211-33<\/li>\n<li><b>Phase 1a, HBV, Food effect study<\/b>: A phase 1, open label, randomized; 4-way crossover study in subjects with chronic hepatitis B virus infection to assess pharmacokinetics (fasted\/fed), safety, tolerability and pharmacodynamics of single oral doses of Farnesoid X receptor agonist EYP001a.<br \/>\n<a href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03320616\" target=\"_blank\" rel=\"noopener\"> NCT03320616<\/a> ; EudraCT 2016-004713-27<\/li>\n<li><b>Phases 1b, Healthy volunteers, Entecavir drug interaction study<\/b>: Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of EYP001a combined with ETV in healthy men and women dosed in the morning under fasted conditions.<br \/>\n<a href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT03469583\" target=\"_blank\" rel=\"noopener\"> NCT03469583<\/a><\/li>\n<li><b>Phase 1, Healthy subjects<\/b>: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability and 51ÂÜÀòcokinetics of EYP001a in Healthy Male Subjects.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03110276\" target=\"_blank\" rel=\"noopener\"> NCT03110276<\/a> ; EudraCT 2016-003035-37<\/li>\n<li><b>Phase 1, Human Mass Balance Study<\/b>: A Phase 1 study to investigate the absorption, metabolism, and excretion of EYP001a as well as the safety\/tolerability of EYP001a following the administration of a single oral dose to healthy male volunteers.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04037618\" target=\"_blank\" rel=\"noopener\"> NCT04037618<\/a> ; EudraCT 2019-001304-37<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<h2>Vonafexor est actuellement en \u00e9valuation dans 3 \u00e9tudes cliniques<\/h2>\n<ul>\n<li><strong>Phase 2 ALPESTRIA-1:<\/strong> Etude d&#8217;innocuit\u00e9 et preuve de concept, d&#8217;escalade de doses fixes de Vonafexor, chez des patients \u00e0 risque de progression du syndrome d&#8217;Alport. <a href=\"https:\/\/www.enyopharma.com\/fr\/syndrome-alport\/\" target=\"_blank\" rel=\"noopener\">En savoir plus sur l&#8217;\u00e9tude clinique ALPESTRIA-1<\/a><\/li>\n<li><strong>Phase 2 MRC avec MASH suspect\u00e9:<\/strong> Vonafexor chez des sujets pr\u00e9sentant une insuffisance r\u00e9nale et une suspicion de st\u00e9atoh\u00e9patite associ\u00e9e \u00e0 un dysfonctionnement m\u00e9tabolique (MASH).<\/li>\n<\/ul>\n<p><a class=\"read-more\" href=\"https:\/\/www.enyopharma.com\/fr\/science\/essais-cliniques\/\">Lire la suite&nbsp;&raquo;<\/a><\/p>\n","protected":false},"author":2,"featured_media":1014,"parent":4320,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-4342","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"jetpack_sharing_enabled":true,"rttpg_featured_image_url":{"full":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=2000%2C750&ssl=1",2000,750,false],"landscape":["https:\/\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg",2000,750,false],"portraits":["https:\/\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg",2000,750,false],"thumbnail":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?resize=150%2C150&ssl=1",150,150,true],"medium":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=300%2C113&ssl=1",300,113,true],"large":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=1024%2C384&ssl=1",1024,384,true],"1536x1536":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=1536%2C576&ssl=1",1536,576,true],"2048x2048":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=2000%2C750&ssl=1",2000,750,true],"large_home":["https:\/\/i0.wp.com\/www.enyopharma.com\/wp-content\/uploads\/2016\/03\/pipeline.jpg?fit=1400%2C525&ssl=1",1400,525,true]},"rttpg_author":{"display_name":"editor51ÂÜÀò51ÂÜÀò","author_link":"https:\/\/www.enyopharma.com\/fr\/author\/editorenyopharma\/"},"rttpg_comment":0,"rttpg_category":null,"rttpg_excerpt":"Vonafexor est actuellement en \u00e9valuation dans 3 \u00e9tudes cliniques Phase 2 ALPESTRIA-1: Etude d&#8217;innocuit\u00e9 et preuve de concept, d&#8217;escalade de doses fixes de Vonafexor, chez des patients \u00e0 risque de progression du syndrome d&#8217;Alport. En savoir plus sur l&#8217;\u00e9tude clinique ALPESTRIA-1 Phase 2 MRC avec MASH suspect\u00e9: Vonafexor chez des sujets pr\u00e9sentant une insuffisance r\u00e9nale&hellip;","_links":{"self":[{"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/pages\/4342","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/comments?post=4342"}],"version-history":[{"count":11,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/pages\/4342\/revisions"}],"predecessor-version":[{"id":6358,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/pages\/4342\/revisions\/6358"}],"up":[{"embeddable":true,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/pages\/4320"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/media\/1014"}],"wp:attachment":[{"href":"https:\/\/www.enyopharma.com\/fr\/wp-json\/wp\/v2\/media?parent=4342"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}