{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T14:57:40Z","timestamp":1790521060381,"version":"4.1.0"},"reference-count":36,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:00:00Z","timestamp":1790294400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To critically review the pharmacology, clinical efficacy, safety, and potential therapeutic role of lerodalcibep-liga within the expanding landscape of proprotein convertase subtilisin\/kexin type 9 (PCSK9)-directed therapies for patients with hypercholesterolemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched through August 2026.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>Clinical trials evaluating lerodalcibep-liga in patients with hypercholesterolemia were included. Full-text peer-reviewed publications underwent detailed evaluation; conference abstracts and posters were summarized descriptively. The search identified one phase 1 study, two phase 2 trials, and six phase 3 trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Monthly subcutaneous lerodalcibep-liga produced low-density lipoprotein cholesterol (LDL-C) reductions of approximately 50% to 65% in patients with heterozygous familial hypercholesterolemia (HeFH), established cardiovascular disease, or high cardiovascular risk. Reductions in apolipoprotein B, non\u2013high-density lipoprotein cholesterol, and lipoprotein(a) were also reported. Low-density lipoprotein cholesterol lowering was maintained through 72\u2009weeks in an open-label extension. Treatment was generally well tolerated, although injection-site reactions occurred more frequently than with placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to patient care and clinical practice in comparison with existing drugs:<\/jats:title>\n                    <jats:p>Lerodalcibep-liga provides potent LDL-C lowering through a fixed, small-volume, once-monthly self-administered injection. Its efficacy is broadly comparable with other PCSK9-directed therapies, but direct comparative evidence remains limited. Analyses suggested a potential cardiovascular benefit, but this finding has not been confirmed in a dedicated, adequately powered cardiovascular outcomes trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Lerodalcibep-liga is an additional potent injectable PCSK9-directed treatment for adults requiring substantial LDL-C reduction, including those with HeFH. However, alirocumab or evolocumab may remain preferable when demonstrated cardiovascular event reduction is a major consideration in treatment selection.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280261488073","type":"journal-article","created":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T09:32:41Z","timestamp":1790328761000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Lerodalcibep-liga as an Injectable Proprotein Convertase Subtilisin\/Kexin Type 9 (PCSK9)-Targeted Therapy for Patients With Hypercholesterolemia"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7635-8567","authenticated-orcid":false,"given":"Mohammad T.","family":"Alashqar","sequence":"first","affiliation":[{"name":"Institute of Therapeutic Innovations and Outcomes, College of Pharmacy, The Ohio State University, Columbus, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolas","family":"Lako","sequence":"additional","affiliation":[{"name":"College of Pharmacy, The Ohio State University, Columbus, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1936-0666","authenticated-orcid":false,"given":"Milap C.","family":"Nahata","sequence":"additional","affiliation":[{"name":"Institute of Therapeutic Innovations and Outcomes, College of Pharmacy, The Ohio State University, Columbus, USA"},{"name":"College of Medicine, The Ohio State University, Columbus, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,9,25]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s41043-025-01054-3"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000001123"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.044795"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.018791"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.3389\/fgene.2022.840797"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.03.057"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2026.01.011"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht273"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1097\/MOL.0000000000000114"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801174"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.4997\/JRCPE.2017.212"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.7573\/dic.2023-12-3"},{"key":"e_1_3_3_14_2","unstructured":"US Food and Drug Administration. BLA approval letter: Lerochol (Lerodalcibep -Liga) BLA 761427. Approved December 12 2025. Accessed July 24 2026. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2025\/761427Orig1s000ltr.pdf"},{"key":"e_1_3_3_15_2","unstructured":"US Food and Drug Administration. FDA approves first oral PCSK9 inhibitor to lower LDL cholesterol in adults with high cholesterol. Published July 17 2026. Accessed July 24 2026. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(24)00313-9"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehad596"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2024.1659"},{"key":"e_1_3_3_19_2","unstructured":"US Food and Drug Administration. Drug trials snapshots: LEROCHOL. Published February 4 2026. Accessed July 24 2026. https:\/\/www.fda.gov\/drugs\/drug-trials-snapshots\/drug-trials-snapshots-lerochol"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(19)32320-4"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2019.06.019"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2020.10.039"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2024.118513"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2026.0879"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2024.118406"},{"key":"e_1_3_3_26_2","unstructured":"LIB Therapeutics Inc. LEROCHOL (lerodalcibep-liga) injection for subcutaneous use: prescribing information. US Food and Drug Administration. Revised December 2025. 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