{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T21:30:32Z","timestamp":1791322232668,"version":"4.3.1"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,6,4]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">A phase 3 trial was conducted to evaluate the efficacy and safety of ongericimab, a monoclonal antibody that inhibits proprotein convertase subtilisin\/kexin type 9, as an add\u2010on treatment to optimized lipid\u2010lowering therapy in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods and Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      A total of 806 patients who were receiving stable and optimized lipid\u2010lowering therapy but did not achieve their low\u2010density lipoprotein cholesterol (LDL\u2010C) targets were enrolled and randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150\u2009mg or matching placebo every 2\u2009weeks, or ongericimab 300\u2009mg or matching placebo every 4\u2009weeks for 52\u2009weeks. Efficacy and safety were evaluated in 802 patients who received at least 1 dose of ongericimab or placebo. The primary end point was the percentage change in LDL\u2010C from baseline to week 24. Our findings demonstrated that the least\u2010squares mean difference of percentage change in LDL\u2010C from baseline to week 24 was \u221267.7% (95% CI, \u221272.5% to \u221263.0%;\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.0001) in the ongericimab 150\u2009mg every 2\u2009weeks group compared with the placebo every 2\u2009weeks group, and \u221261.2% (95% CI, \u221267.1% to \u221255.2%;\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.0001) in the ongericimab 300\u2009mg every 4\u2009weeks group compared with the placebo every 4\u2009weeks group. These reductions were sustained up to week 52. Furthermore, treatment with ongericimab favorably altered other lipid parameters. A similar incidence of adverse events was observed in the ongericimab and placebo groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">Ongericimab, as an add\u2010on treatment to optimized lipid\u2010lowering therapy, significantly reduced LDL\u2010C and was well\u2010tolerated in Chinese patients with primary hyperlipidemia and mixed dyslipidemia who did not achieve their LDL\u2010C targets.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT04781114.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.123.033669","type":"journal-article","created":{"date-parts":[[2024,5,31]],"date-time":"2024-05-31T07:15:49Z","timestamp":1717139749000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1979-0287","authenticated-orcid":false,"given":"Xiaozeng","family":"Wang","sequence":"first","affiliation":[{"name":"General Hospital of Northern Theater Command Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miaohan","family":"Qiu","sequence":"additional","affiliation":[{"name":"General Hospital of Northern Theater Command Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhifeng","family":"Cheng","sequence":"additional","affiliation":[{"name":"The Fourth Hospital of Harbin Medical University Harbin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianyou","family":"Ji","sequence":"additional","affiliation":[{"name":"Daqing People\u2019s Hospital Daqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1216-9316","authenticated-orcid":false,"given":"Jiyan","family":"Chen","sequence":"additional","affiliation":[{"name":"Guangdong General Hospital Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Zhu","sequence":"additional","affiliation":[{"name":"The Affiliated Hospital of Xuzhou Medical University Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yida","family":"Tang","sequence":"additional","affiliation":[{"name":"Peking University Third Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5854-1377","authenticated-orcid":false,"given":"Zhouqing","family":"Huang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Wenzhou Medical University Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guohai","family":"Su","sequence":"additional","affiliation":[{"name":"Jinan Central Hospital Jinan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaopin","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Jinzhou Medical University Jinzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1539-5212","authenticated-orcid":false,"given":"Zhijun","family":"Huang","sequence":"additional","affiliation":[{"name":"The Third Xiangya Hospital of Central South University Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhuhua","family":"Yao","sequence":"additional","affiliation":[{"name":"Tianjin People\u2019s Hospital Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinxiu","family":"Lin","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Fujian Medical University Fuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7812-9793","authenticated-orcid":false,"given":"Yihong","family":"Sun","sequence":"additional","affiliation":[{"name":"China\u2010Japan Friendship Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunhui","family":"Li","sequence":"additional","affiliation":[{"name":"The First Hospital of Nanchang Nanchang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cong","family":"Shao","sequence":"additional","affiliation":[{"name":"Shanghai Junshi Biosciences Co., Ltd. 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