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Evinacumab in Patients with Refractory Hypercholesterolemia
Open accessAbstract
BACKGROUND: Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known. METHODS: In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis. Patients were randomly assigned to receive subcutaneous or intravenous evinacumab or placebo. The primary end point was the percent change from baseline in the LDL cholesterol level at week 16 with evinacumab as compared with placebo. RESULTS: In total, 272 patients were randomly assigned to the following groups: subcutaneous evinacumab at a dose of 450 mg weekly (40 patients), 300 mg weekly (43 patients), or 300 mg every 2 weeks (39 patients) or placebo (41 patients); or intravenous evinacumab at a dose of 15 mg per kilogram of body weight every 4 weeks (39 patients) or 5 mg per kilogram every 4 weeks (36 patients) or placebo (34 patients). At week 16, the differences in the least-squares mean change from baseline in the LDL cholesterol level between the groups assigned to receive subcutaneous evinacumab at a dose of 450 mg weekly, 300 mg weekly, and 300 mg every 2 weeks and the placebo group were -56.0, -52.9, and -38.5 percentage points, respectively (P<0.001 for all comparisons). The differences between the groups assigned to receive intravenous evinacumab at a dose of 15 mg per kilogram and 5 mg per kilogram and the placebo group were -50.5 percentage points (P<0.001) and -24.2 percentage points, respectively. The incidence of serious adverse events during the treatment period ranged from 3 to 16% across trial groups. CONCLUSIONS: In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose. (Funded by Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03175367.).
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“Another phase 2 trial studied evinacumab in 272 patients with refractory hypercholesterinaemia (either HeFH or established atherosclerosis). At a dose of 450 mg per week, evinacumab reduced LDL-C levels by − 56% compared with baseline [151].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [151]
Experimental — accuracy not yet measuredIn the citing paper
“In comparison, evinacumab, a monoclonal antibody against ANGPTL3 that is thought to cause near-total suppression of ANGPTL3 activity, 7,14,15 reduces ApoB levels by >40% in adults with refractory hypercholesterolemia or homozygous familial hypercholesterolemia in its intravenous formulation administered at a dose of 15 mg/kg.14,15”
From Effect of Vupanorsen on Non–High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70 (2022) · cites this paper as [15]
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“Another interesting target, which is mainly involved in the increase of triglycerides and other lipids levels, is the angiopoietin-like 3 (ANGPTL3), known to inhibit lipoprotein lipase and endothelial lipase.(8,9) A fully monoclonal antibody against ANGPTL3, evinacumab, underwent advanced clinical development and was…”
BackgroundSelf-citationHow to Handle Elevated Triglycerides: Life after PROMINENT
Pirillo, A., & Catapano, A. L. (2023) · Current Atherosclerosis Reports · doi:10.1007/s11883-023-01175-2 · Cited by 15
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“In patients with refractory hypercholesterolemia, the use of evinacumab reduced the LDL-C by more than 50% at the maximum dose.(67) Evinacumab has been approved by the FDA for use in homozygous FH.”
BackgroundEvinacumab for treatment of familial hypercholesterolemia
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“, alirocumab, evolocumab, and inclisiran) [18–23], and evinacumab [24,25], have been shown to significantly reduce LDL-C levels in adult HoFH patients.”
BackgroundEvinacumab for Homozygous Familial Hypercholesterolemia
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New Trends and Therapies for Familial Hypercholesterolemia
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“5–56% reduction depending on dose regimen and patient [62].”
BackgroundManagement of Familial Hypercholesterolemia with Special Emphasis on Evinacumab
Krzemińska, J., Młynarska, E., Radzioch, E., Wronka, M., Rysz, J., & Franczyk, B. (2022) · Biomedicines · doi:10.3390/biomedicines10123273 · Cited by 9
“There was no significant difference in the incidence of serious adverse events between groups treated with intravenous or subcutaneous therapy [77].”
BackgroundFamilial Hypercholesterolemia: Pitfalls and Challenges in Diagnosis and Treatment
Arnold, N., & Köenig, W. (2023) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2408236 · Cited by 11
“Approximately 50% LDL-C reduction under evinacumab therapy has been demonstrated in HoFH subjects and those with refractory hypercholesterolemia [99,100].”
BackgroundBea, A. M., González-Guerrero, A., Cenarro, A., Lamíquiz-Moneo, I., Climent, E., Jarauta, E., Gracia‐Rubio, I., Benaiges, D., Laclaustra, M., Tejedor, M. T., et al. (2024) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2024.118617 · Cited by 7
Xu, Y., Guo, J., Zhang, L., Miao, G., Lai, P., Zhang, W., Liu, L., Hou, X., Wang, Y., Huang, W. Y., et al. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.840358 · Cited by 7
“For example, evinacumab, an antibody that inhibits ANGPTL3 not only reduces TG level in circulation by enhancing LPL activity but also significantly decreases low-density lipoprotein cholesterol (LDL-C) in patients with familial hypercholesterolemia (FH) in two independent phase 3 trials (5, 6).”
BackgroundKhoury, É., Croteau, L., Lauzière, A., & Gaudet, D. (2022) · Future Cardiology · doi:10.2217/fca-2021-0149 · Cited by 8
Self-citation2022 Consensus statement on the management of familial hypercholesterolemia in Korea
Lee, C. J., Yoon, M., Kang, H., Kim, B. J., Choi, S. H., Jeong, I., Lee, S., on behalf of Task Force Team for Familial Hypercholesterolemia, & Korean Society of Lipid and Atherosclerosis (2022) · The Korean Journal of Internal Medicine · doi:10.3904/kjim.2022.121 · Cited by 10
“Because the exposure of vessels of patients with HoFH to lipids is more severe than that of patients with HeFH, the incidence of CAD under the age of 20 is not uncommon.”
BackgroundInfluentialA stepwise approach to prescribing novel lipid-lowering medications
Kakavand, H., Aghakouchakzadeh, M., Shahi, A., Virani, S. S., Dixon, D. L., Tassell, B. W. V., & Talasaz, A. H. (2022) · Journal of clinical lipidology · doi:10.1016/j.jacl.2022.10.003 · Cited by 7
Angiopoietin-like protein 3: a novel potential biomarker for nephrotic syndrome in children
Wen, F., Liu, J., Dai, R., Hong, S., Ji, B., Liu, J., Zhang, J., Han, X., Lv, Q., Liu, J., et al. (2023) · Frontiers in Pediatrics · doi:10.3389/fped.2023.1113484 · Cited by 6
Advances in familial hypercholesterolemia
Paquette, M., & Baass, A. W. (2024) · Advances in clinical chemistry · doi:10.1016/bs.acc.2024.02.004 · Cited by 6
Pushing the limits of LDL cholesterol: Emerging paradigms in cardiovascular risk reduction
Yaghoubi, D., & Sallam, T. (2025) · Trends in Cardiovascular Medicine · doi:10.1016/j.tcm.2025.07.002 · Cited by 6
“Although longer-term data are still needed, ANGPTL3 inhibitors could prove particularly valuable for these high-risk patient populations [50].”
White, R. T., Sankey, K. H., & Nawarskas, J. J. (2023) · Cardiology in Review · doi:10.1097/crd.0000000000000522 · Cited by 6
Liu, S., Ke, J., Feng, X., Wang, Z., Wang, X., Yang, L., & Zhao, D. (2024) · Journal of Diabetes Research · doi:10.1155/2024/2431441 · Cited by 6
“ANGPTL3 inhibition with evinacumab is being developed as an e ff ective treatment to reduce TG and LDL-c [15].”
BackgroundAn up-to-date review of emerging biologic therapies for hypercholesterolemia
Tomlinson, B. (2024) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2024.2442455 · Cited by 6
“Evinacumab was also effective in patients with refractory hypercholesterolemia reducing LDL cholesterol by more than 50% at the maximum dose [60].”
Emerging agents targeting triglycerides
Prakash, Y. S., Bhatt, D. L., & Malick, W. A. (2025) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000979 · Cited by 7
Effects of Inclisiran, Alirocumab, Evolocumab, and Evinacumab on Lipids: A Network Meta-Analysis
Zhang, L., Li, B., Chen, W., Li, W., Yang, H., & Pan, D. (2025) · Reviews in Cardiovascular Medicine · doi:10.31083/rcm25248 · Cited by 9
“LDL-C levels were reported in 20 articles [22–36 , 38– 42”
Hussain, A., Rifai, M. A., Mahtta, D., Liu, J., Jain, V., & Virani, S. S. (2021) · Current Atherosclerosis Reports · doi:10.1007/s11883-020-00900-5 · Cited by 6
“A previous phase 3 study of evinacumab in patients with homozygous familial hypercholesterolemia (FH) showed a between-group mean difference of 49% in reduction in LDL-C compared to placebo [5]. The present phase 2 clinical trial sought to evaluate the efficacy and safety of subcutaneous (SC) and intravenous (IV) evin…”
BackgroundMethodResultInfluentialKholaif, N., Mohamed, T. I., Alharbi, I. S., Aljenedil, S., Alhumaidan, H., Al-Ashwal, A. A., Almahfouz, A., Algorashi, S., Almasood, A. S., & Baqal, O. J. (2023) · Monaldi Archives for Chest Disease · doi:10.4081/monaldi.2023.2503 · Cited by 6
Identifying the Lipidomic Effects of a Rare Loss-of-Function Deletion in ANGPTL3
Blackburn, N. B., Meikle, P. J., Peralta, J. M., Kumar, S., Leandro, A. C., Bellinger, M. A., Giles, C., Huynh, K., Mahaney, M. C., Göring, H. H. H., et al. (2021) · Circulation Genomic and Precision Medicine · doi:10.1161/circgen.120.003232 · Cited by 6
Surma, S., Romańczyk, M., & Filipiak, K. J. (2021) · Folia Cardiologica · doi:10.5603/fc.2021.0005 · Cited by 6
“Despite previous intensive lipid-lowering therapy, use of evinacumab in patients with HeHF and treatment-resistant hypercholesterolaemia lead to plasma LDL reduction by another 50% [34].”
BackgroundMethodInfluentialInhibiting angiopoietin-like protein 3: clear skies or clouds on the horizon?
Hegele, R. A. (2024) · European Heart Journal · doi:10.1093/eurheartj/ehae068 · Cited by 7
Maidman, S. D., & Rosenson, R. S. (2025) · BioDrugs · doi:10.1007/s40259-025-00731-3 · Cited by 7
“A similar LDL-lowering effect was observed when the drug was trialed among patients with refractory hypercholesterolemia, in which 72% of included patients had heterozygous FH [82].”
Self-citationNew and Emerging Therapeutic Targets for ApoB-Containing Particles Lowering
Gaudet, D., Larouche, M., Raal, F. J., & Catapano, A. L. (2026) · Circulation Research · doi:10.1161/circresaha.126.327270 · Cited by 5
Self-citationQureshi, Z. A., Khanzada, M., Safi, A., Fatima, E., Altaf, F., & Vittorio, T. J. (2024) · Annals of Medicine and Surgery · doi:10.1097/ms9.0000000000001945 · Cited by 5
“[83] .”
Rangwala, H. S., Fatima, H., Ali, M., Shafique, M. A., Rangwala, B. S., Virwani, V., Kumar, A., Arsal, S. A., Raja, A., Raja, S., et al. (2024) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-024-00649-1 · Cited by 5
“In a phase II randomized clinical study, conducted over the double-blind treatment period, evinacumab demonstrated significant efficacy in lowering LDL-C levels in individuals, both with and without heterozygous FH and refractory hypercholesterolemia [14].”
Brown, L., Ruel, I. L., Baass, A. W., Bergeron, J., Brunham, L. R., Cermakova, L., Couture, P., Gaudet, D., Francis, G. A., Hegele, R. A., et al. (2023) · Canadian Journal of Health Technologies · doi:10.51731/cjht.2023.572 · Cited by 5
Self-citationLi, Y., Zhang, Y., Zhang, Y., Lin, T., Gao, Y., Cai, Y., Zhou, C., Yang, L., Liu, B., Dong, S., et al. (2023) · Pharmaceutical Biology · doi:10.1080/13880209.2023.2243999 · Cited by 5
ANGPTL3 inhibition for hypercholesterolaemia
Lim, G. B. (2020) · Nature Reviews Cardiology · doi:10.1038/s41569-020-00483-3 · Cited by 5
New therapeutic approaches for the treatment of hypertriglyceridemia
Gouni‐Berthold, I., & Schwarz, J. (2022) · Herz · doi:10.1007/s00059-022-05113-x · Cited by 6
“[42] investigated the efficacy and safetyof evinacumab inpatients with refractory hypercholesterolemia, defined as an LDL-C of≥ 70mg/dl in patients with atherosclerotic CVD or≥ 100mg/dl in patients without atherosclerotic CVD”
BackgroundConcolino, P., Paolis, E. D., Moffa, S., Onori, M. E., Soldovieri, L., Tenore, C. R., Bonis, M. D., Rabacchi, C., Santonocito, C., Rinelli, M., et al. (2023) · Genes · doi:10.3390/genes14061275 · Cited by 4
“Therefore, we thought that the patient could tolerate it, although this drug has a reduction effect on LDL cholesterol close to 20 percent, waiting for more effective drugs such as Evinacumab [10,11].”
BackgroundGrassi, G. M., Pinto, R. D., Rosei, C. A., Agnoletti, D., Borghi, C., Cicero, A. F. G., Ciuceis, C. D., Desideri, G., Grassi, D., Muiesan, M. L., et al. (2022) · High Blood Pressure & Cardiovascular Prevention · doi:10.1007/s40292-021-00501-6 · Cited by 8
“Evinacumab is a fully human monoclonal antibody with inhibitory effect on angiopoietin-like protein 3 (ANGPTL3) [39, 40], the gene of which is predominantly expressed in the liver [41].”
BackgroundDysregulated Lipid Metabolism as a Central Driver of Atherosclerotic Plaque Pathology
Steinbeck, J. E., Iannotti, R. A., & Rasheed, A. (2025) · Lipidology · doi:10.3390/lipidology2040017 · Cited by 5
“…antibody Evinacumab has been approved for patients with persistent hypercholesterolemia, such as those with homozygous FH, which decreases circulating LDL cholesterol levels [284,285]. cholesterol is taken up from the circulation by apolipoprotein-B100 (Apo-B100) binding to the LDL receptor (LDLR).”
Fibrates : Do They Still Have a Role in Therapy in 2025?
Pirillo, A., Zambon, A., & Catapano, A. L. (2025) · Current Atherosclerosis Reports · doi:10.1007/s11883-025-01379-8 · Cited by 4
“ANGPTL3 inhibitors such as evinacumab have produced profound triglyceride and LDL-C reductions, even in patients with refractory dyslipidaemia [ 33 ].”
Bibliometric analysis of monoclonal antibodies for atherosclerosis
Ma, J., Zhao, K., Zhu, Y., Wen, X., Huang, J., Wei, X., & Zhao, Z. (2023) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2023.2266926 · Cited by 5
“20,21 IL-1β has become a prominent role linked to atherosclerosis, going beyond objectives of lipid metabolism.”
BackgroundEmerging therapies for refractory hypercholesterolemia: a narrative review
Pawlos, A., Khoury, É., & Gaudet, D. (2024) · Future Cardiology · doi:10.1080/14796678.2024.2367860 · Cited by 4
Self-citationHyperlipidemia: effective disease management with a focus on PCSK9 inhibitors
Shaw, P. B. (2021) · The American Journal of Managed Care · doi:10.37765/ajmc.2021.88606 · Cited by 4
Current and emerging drugs for the treatment of atherosclerosis: the evidence to date
Rizvi, A. A., Popovic, D. S., Παπάνας, Ν., Stoian, A. P., Almahmeed, W. A., Sahebkar, A., Janež, A., & Rizzo, M. (2022) · Expert Review of Cardiovascular Therapy · doi:10.1080/14779072.2022.2094771 · Cited by 4
“The efficacy and safety of evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, was evaluated in a double-blind, placebo-controlled, phase 2 trial in patients with refractory hypercholesterolemia [53].”
BackgroundCurrent and emerging monoclonal antibodies for treating familial hypercholesterolemia in children
Reijman, M. D., Kusters, D. M., & Wiegman, A. (2024) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2024.2330948 · Cited by 4
“This may change in the future since evinacumab has also been tested in adults with refractory hypercholesterolemia, including HeFH [28].”
BackgroundThe era of targeted therapy for hyperlipidemia
Чубыкина, У. В., Tyurina, A. V., & Владиславович, Е. М. (2024) · Russian Journal of Cardiology · doi:10.15829/1560-4071-2024-6038 · Cited by 6
Larouche, M., Banerjee, P., Brisson, D., Pordy, R. C., & Gaudet, D. (2025) · Journal of the Endocrine Society · doi:10.1210/jendso/bvaf025 · Cited by 4
Self-citation
Metadata
- Authors
- Rosenson, R. S., Burgess, L. J., Ebenbichler, C. F., Baum, S. J., Stroes, E. S. G., Ali, S., Khilla, N., Hamlin, R., Pordy, R., Dong, Y., Son, V., & Gaudet, D.
- Affiliations
- Innsbruck Medical University (AT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-12-10
- Volume
- 383
- Issue
- 24
- Pages
- 2307-2319
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3098138308
- Semantic Scholar
- ac311c54adb72af58fcfc75c3ae055aadb835e6b
- Cited by
- 302
- References
- 41
- Citations by year
- 2026: 27 · 2025: 45 · 2024: 52 · 2023: 55 · 2022: 55 · 2021: 65 · 2020: 3
- FWCI
- 40.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- evinacumab, LDL cholesterol lowering, ANGPTL3, heterozygous familial hypercholesterolemia, atherosclerosis, subcutaneous administration, intravenous administration, monoclonal antibodies, lipid-lowering therapy, adverse events, dose comparison, treatment efficacy and safety, atherosclerotic cardiovascular disease
- MeSH terms
- Angiopoietin-like Proteins, Angiopoietin-Like Protein 3, Adult, Antibodies, Monoclonal, Anticholesteremic Agents, Double-Blind Method, Drug Administration Schedule, Drug Resistance, Female, Humans, Hyperlipoproteinemia Type II, Infusions, Intravenous, Injections, Subcutaneous, Cholesterol, LDL, Male, Middle Aged, Antibodies, Monoclonal, Humanized
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