{"id":138255,"date":"2024-04-07T18:29:07","date_gmt":"2024-04-07T22:29:07","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=138255"},"modified":"2024-04-07T18:29:07","modified_gmt":"2024-04-07T22:29:07","slug":"liberate-hr-trial-lerodalcibep-a-small-binding-protein-based-pcsk9-inhibitor-administered-monthly-significantly-lowered-ldl-c","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=138255","title":{"rendered":"LIBerate-HR Trial: Lerodalcibep, A Small-Binding Protein Based PCSK9 Inhibitor Administered Monthly Significantly Lowered LDL-C"},"content":{"rendered":"

Key Points<\/span><\/b>\u00a0<\/span><\/p>\n

– Newer cholesterol guidelines advise lower target values for LDL-C for high-risk patients, yet many patients do not reach this goal on statin therapy alone<\/span>
\n<\/span>– Lerodalcibep is a small binding protein that blocks binding of PCS9 inhibitor to the LDL-R, promoting increased uptake of LDL-C<\/span>
\n<\/span>– LIBerate-HR trial assessed the efficacy and safety of lerodalcibep in patients at very-high and high risk for CVD compared to placebo <\/span>
\n<\/span>– Lerodalcibep, injected once monthly, was found to significantly lower LDL-C as well as ApoB and Lp(a), compared to placebo<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

Newer cholesterol guidelines advise lower target values for LDL-C in patients with or at high-risk of cardiovascular disease (CVD). PCSK9 Inhibitors are useful for adequately lowering LDL-C in patients already on statin therapy and not at LDL-C goal.<\/span>\u00a0<\/span><\/p>\n

Current injectable PCSK9 inhibitors rely on monoclonal antibodies to block PCSK9 from binding to the LDL-Receptor and are usually injected twice a month.\u00a0 However, Lerodalcibep, a small binding protein with a high degree of stability, permits once a month injection.<\/span>\u00a0<\/span><\/p>\n

Dr. Eric Klug from the University of Witwatersrand, South Africa, presented the findings of the LIBerate-HR trial at ACC 2024, which investigated the effect on Lerodalcibep in those with CVD or at high risk who are already on statin therapy<\/span>\u00a0<\/span><\/p>\n

A total of 922 participants with CVD or high risk for CVD were randomized in this double-blind, placebo-controlled, multi-national trial to receive monthly 1.2 ml subcutaneous Lerodalcibep (300 mg) or placebo for 52 weeks. The co-primary endpoints were a percent change in LDL-C at 52 weeks and the average of week 50 and 52, compared to baseline. Secondary outcomes included measurements of other lipids and apolipoproteins. \u00a0<\/span>\u00a0<\/span><\/p>\n

The median age of the participant was 64 years, 45% were female, 78% were white, the average LDL-C was 116mg\/dL, and 48% had clinical ASCVD. In the treatment group, 82% of participants were on a stable dose of a statin and 16% taking ezetimibe.<\/span>\u00a0<\/span><\/p>\n

At 52 weeks, Lerodalcibep decreased LDL-C by 56% (60.6mg\/dl) and by 62% when using the mean LDL-C at week 50 and 52 (74.5 mg\/dL). Over 90% of participants receiving Lerodalcibep achieved a target LDL-C of less than 55mg\/dl.Significant improvements were also noted in other lipid parameters. ApoB and Lp(a) levels decreased 43% and 33% respectively in the intention-to-treatment analysis at 52 weeks.<\/span>\u00a0<\/span><\/p>\n

There were no significant differences in discontinuation of Lerodalcibep or placebo. Injection site reactions were more common with Lerodalcibep (6.9% vs 0.3%) but graded as mild to moderate. Lastly, Lerodalcibep, in-vivo, did not demonstrate significant anti-drug antibodies that would diminish the effect of the drug.<\/span>\u00a0<\/span><\/p>\n

\u201cThese are the first long-term data for lerodalcibep, which showed it to be both highly effective and safe after one year of follow-up,\u201d said Eric Klug, MBBCh, MMed, of the University of Witwatersrand in Johannesburg, South Africa, and the study\u2019s lead author. \u201cWe have demonstrated persistent LDL- cholesterol-lowering efficacy over 52 weeks, with over 90% of patients achieving both a reduction greater than 50% and the new much lower LDL targets. In addition, lerodalcibep was well-tolerated, with minimal adverse effects.\u201d<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Key Points\u00a0 – Newer cholesterol guidelines advise lower target values for LDL-C for high-risk patients, yet many patients do not reach this goal on statin therapy alone – Lerodalcibep is a small binding protein that blocks binding of PCS9 inhibitor to the LDL-R, promoting increased uptake of LDL-C – LIBerate-HR trial assessed the efficacy and […]<\/p>\n","protected":false},"author":40603,"featured_media":138256,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[888,8],"tags":[889,45,47,185],"ppma_author":[1029],"class_list":{"0":"post-138255","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-acc-2024","8":"category-news","9":"tag-acc-2024","10":"tag-conference","11":"tag-featured","12":"tag-news","13":"author-leah-kosyakovsky"},"authors":[{"term_id":1029,"user_id":40603,"is_guest":0,"slug":"leah-kosyakovsky","display_name":"Leah Kosyakovsky","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/864bde69f6f1f80e91e4a97f0a0ba8daa64c2bb702be09ed787444c7dfa045bb?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138255","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/40603"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=138255"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138255\/revisions"}],"predecessor-version":[{"id":138257,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138255\/revisions\/138257"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/138256"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=138255"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=138255"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=138255"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=138255"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}