> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-olezarsen-isis-678354-in-participants-with-3ccff9c9-7155-423c-aecc-7da1b979218d > Record changed: 2026-10-13 # A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia NCT05610280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Participants 1,478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Lead sponsor Ionis Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Start date 2022-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) Number of sites 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Title and summary **Summary** The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Short title** A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Official title** A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Dates **Completion date** 2025-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **First posted** 2022-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Registry last updated** 2026-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Primary completion date** 2024-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Start date** 2022-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Size and sites **Actual participants** 1,478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Participants** 1,478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Number of sites** 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Lead sponsor** Ionis Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Identifiers **Registry ID** NCT05610280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **ClinicalTrials.gov ID** NCT05610280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline to Week 25 in Fasting Triglycerides (TG) Compared to Placebo Timeframe: Baseline to Week 25 ### Secondary outcomes 1. Percent Change From Baseline to Week 53 in Fasting TG Compared to Placebo Timeframe: Baseline to Week 53 2. Proportion of Participants who Achieve Fasting TG <150 Milligrams per Deciliter (mg/dL) at Weeks 25 and 53 Compared to Placebo Timeframe: Baseline, Weeks 25 and 53 3. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein C-III (apoC-III) Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 4. Percent Change From Baseline to Weeks 25 and 53 in Fasting Very Low-Density Lipoprotein-Cholesterol (VLDL)-C Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 5. Percent Change From Baseline to Weeks 25 and 53 in Fasting Remnant Cholesterol Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 6. Percent Change From Baseline to Weeks 25 and 53 in Fasting non-High Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 7. Percent Change From Baseline to Weeks 25 and 53 in Fasting High-Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 8. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B (apoB) Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 9. Percent Change From Baseline to Weeks 25 and 53 in Fasting Low-Density Lipoprotein-Cholesterol (LDL)-C Compared to Placebo Timeframe: Baseline to Weeks 25 and 53 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must fall into 1 of the following groups (a or b): a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter \[mmol/L\]) and <500 mg/dL (5.65 mmol/L) with either - Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or - At increased risk for ASCVD b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L) - Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study. ### Exclusion criteria - Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening - Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal - Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome - Estimated GFR < 30 mL/min/1.73 m^2 NOTE: Other Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Sites - Alabama Clinical Therapeutics, LLC AlabasterBirmingham, United States - Heart Center Research PCHuntsville, United States - Cardiovascular Research Foundation of Southern CaliforniaBeverly Hills, United States - Westside Medical Associates of Los AngelesBeverly Hills, United States - Diabetes/Lipid Management & Research CenterHuntington Beach, United States - University of California, San Diego (UCSD)La Jolla, United States - Clinical Trials ResearchLincoln, United States - Amicis ResearchNorthridge, United States - Valley Clinical Trials, Inc.Northridge, United States - Northern California ResearchSacramento, United States - Amicis Research CenterSanta Clarita, United States - Metabolic Institute of AmericaTarzana, United States - Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorrance, United States - Amicis Research CenterValencia, United States - Excel Clinical Medical TrialsBoca Raton, United States - Finlay Medical Research - West PalmGreenacres City, United States - Global Research AssociatesHomestead, United States - 3Sync ResearchLake Worth, United States - Finlay Medical ResearchMiami, United States - Advanced Medical Research Institute (AMRI)Miami, United States - De La Cruz Research Center, LLMiami, United States - Suncoast Clinical Research, Inc. - New Port RicheyNew Port Richey, United States - Suncoast Clinical Research, Inc. - Palm HarborNew Port Richey, United States - Proactive Clinical ResearchOakland Park, United States - Ocala Cardiovascular ResearchOcala, United States And 143 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## References - PubMed 41910513 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41910513/) Related publication - PubMed 40888739 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40888739/) Related publication - PubMed 40081744 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40081744/) Related publication ### Other registry identifiers - 2022-501486-53 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05610280) ## Related records ### Drugs (1) - [Olezarsen sodium](https://trialight.com/data/asset/olezarsen-sodium-70cdc81f-ee08-47f3-b4c0-091a5103a107.md) ### Lead sponsors (1) - [Ionis Pharmaceuticals, Inc.](https://trialight.com/data/company/ionis-pharmaceuticals-inc-1aa08b81-1c67-42a4-9e9b-339a1ca8379b.md) ### Conditions (2) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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