- |||||||||| lerodalcibep (LIB003) / LIB Therap
P3 data, Journal, Head-to-Head: Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial. (Pubmed Central) - Feb 27, 2025 P3 The LDL cholesterol response was highly variable, but generally similar in patients treated with both lerodalcibep and evolocumab. Importantly, the study showed the inability to predict response based on genotyping, reinforcing the rationale for PCSK9 inhibition in all patients with homozygous familial hypercholesterolemia and continuing its use in responders.
- |||||||||| Review, Journal: Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American Heart Association Scientific Sessions. (Pubmed Central) - Feb 6, 2025
Included studies assessed effects of intensive blood pressure control in patients with type 2 diabetes (BPROAD); decision support system for physicians to optimize early lipid lowering therapies after acute coronary syndrome (ZODIAC); efficacy and safety of zerlasiran, a short interfering RNA targeting lipoprotein(a) (ALPACAR); efficacy and safety of muvalaplin an oral disrupter of the assembly of lipoprotein(a) particles (KRAKEN); safety and efficacy of obicetrapib in patients with heterozygous familial hypercholesterolemia (BROOKLYN); efficacy and safety of lerodalcibep, a third generation PCSK9 inhibitor in heterozygous familial hypercholesterolemia subjects (LIBerate-HeFH_OLE); personalized app-based coaching to improve physical activity in patients with HFpEF compared to standard care (MyoMobile); semaglutide to improve cardiovascular outcomes in patients with a history of coronary artery bypass surgery and overweight or obesity (the SELECT trial); efficacy and safety of plozasiran in adults with genetically or clinically defined familial chylomicronemia syndrome at high risk of acute pancreatitis (PALISADE); and transcriptomic signatures and predictors of evolocumab added to maximum statin therapy based on intra-coronary plaque characteristics (YELLOW III). Research presented at the 2024 AHA Scientific Sessions emphasized innovative strategies in cardiovascular disease prevention and management.
- |||||||||| Review, Journal: An up-to-date review of emerging biologic therapies for hypercholesterolemia. (Pubmed Central) - Jan 3, 2025
The antisense oligonucleotide (ASO) and siRNA inhibitors of apoC3 and ANGPTL3 are effective in severe hypertriglyceridemia and homozygous familial hypercholesterolemia, respectively, and may prove to have wider applications. ASO and siRNA inhibitors of Lp(a) are currently in cardiovascular outcome studies.
- |||||||||| Review, Journal: Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American College of Cardiology Conference. (Pubmed Central) - Jun 3, 2024
The AEGIS-II randomized patients with type 1 myocardial infarction (MI) with multivessel coronary artery disease and additional CV risk factors and found no benefit in major adverse CV events (MACE) with CSL112, an apolipoprotein A1 infusion shown to increase cholesterol efflux capacity. The Bridge-TIMI 73a trial showed a significant reduction in triglyceride (TG) levels with olezarsen, an antisense mRNA, in patients with moderate hyperTG with elevated CV risk...The VICTORIAN-INITIATE trial showed efficacy and safety in early use of inclisiran in patients with ASCVD who did not reach target LDL-C?<?70
- |||||||||| Journal: PCSK9-directed therapies: an update. (Pubmed Central) - Jan 26, 2024
Long-term inhibition of PCSK9 with monoclonal antibodies is safe and conveys sustained cardiovascular benefit. Novel strategies to inhibit PCSK9 function such as orally available drugs, RNA targeting, and one-time treatment with gene editing may further enhance the therapeutic armamentarium and enable novel preventive strategies.
- |||||||||| lerodalcibep (LIB003) / LIB Therap
LONG-TERM EFFICACY AND SAFETY OF LERODALCIBEP IN HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (Moderated Poster Theater 08) - Jan 26, 2024 - Abstract #ACC2024ACC_3985; Overall mean age (range) was 52.8 (18-79) years, 51.3% female, 86% white and 14% South Asian, multiracial or black, with 88% on statins, 50.6% on ezetimibe and mean (SD) LDL-C of 153.4 (67.0) mg/dL. Lerodalcibep dosed monthly significantly and persistently reduced LDL-C, apo-B and Lp(a) in HeFH subjects with no attenuation and with a safety profile similar to placebo.
- |||||||||| lerodalcibep (LIB003) / LIB Therap
Enrollment closed, Trial completion date, Trial primary completion date: LIBerate-VI: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients (clinicaltrials.gov) - Dec 10, 2023 P3, N=160, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: Apr 2023 --> Jul 2023 Enrolling by invitation --> Active, not recruiting | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Oct 2023 --> May 2024
- |||||||||| lerodalcibep (LIB003) / LIB Therap
Trial completion date, Trial initiation date, Trial primary completion date: LIBerate-VI: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients (clinicaltrials.gov) - Feb 9, 2022 P3, N=160, Not yet recruiting, Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 Trial completion date: Dec 2022 --> Jul 2023 | Initiation date: Oct 2021 --> Mar 2022 | Trial primary completion date: Oct 2022 --> Jun 2023
- |||||||||| lerodalcibep (LIB003) / LIB Therap
Trial completion, Trial completion date: Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 (clinicaltrials.gov) - Nov 3, 2020 P2b, N=32, Completed, Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Mar 2021 --> May 2022 Active, not recruiting --> Completed | Trial completion date: May 2020 --> Aug 2020
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