> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/core-ole-a-study-of-olezarsen-isis-678354-administered-c1d29f61-b72a-4a3f-bcf7-7519dbc1b5fe > Record changed: 2026-11-04 # CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) NCT05681351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Participants 885 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Lead sponsor Ionis Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Start date 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) Number of sites 262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Short title** CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Official title** An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Dates **Completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **First posted** 2023-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Registry last updated** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Primary completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Start date** 2022-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Size and sites **Actual participants** 885 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Participants** 885 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Number of sites** 262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Lead sponsor** Ionis Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Identifiers **Registry ID** NCT05681351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **ClinicalTrials.gov ID** NCT05681351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Outcomes ### Primary outcomes 1. Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157 Timeframe: Baseline up to Week 157 2. Proportion of Participants Who Experience Adverse Events (AEs) Timeframe: Baseline up to Week 157 3. Proportion of Participants Who Use Concomitant Medications Timeframe: Baseline up to Week 157 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment. - Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6). - A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses). Key Exclusion Criteria: • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment. NOTE: Other Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Sites - LA Universal Research Center, Inc.Los Angeles, United States - University of California, San Diego (UCSD)San Diego, United States - Metabolic Institute of AmericaTarzana, United States - Excel Medical Clinical TrialsBoca Raton, United States - Finlay Medical ResearchGreenacres City, United States - Columbus Clinical Services, LLCMiami, United States - Finlay Medical ResearchMiami, United States - Innovia Research Center, Inc.Miramar, United States - Harmony Clinical Research, Inc.North Miami Beach, United States - R & B Medical Center LLCTampa, United States - VICIS Clinical ResearchTampa, United States - JSV Clinical Research Study, Inc.Tampa, United States - Bayside Clinical ResearchTrinity, United States - Centricity ResearchColumbus, United States - IACT HealthColumbus, United States - Affinity HealthOak Brook, United States - St. Vincent Medical Group, Inc.Carmel, United States - University of Kansas Medical Center (KUMC)Kansas City, United States - The Research Group of Lexington, LLCLexington, United States - Louisville Metabolic and Atherosclerosis Research Center (L-MARC)Louisville, United States - Grace Research, LLCBossier City, United States - University of Maryland School of MedicineBaltimore, United States - IRC ClinicsTowson, United States - Massachusetts General Hospital Heart CenterBoston, United States - University of Michigan- Endocrinology & MetabolismAnn Arbor, United States And 237 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## References ### Other registry identifiers - 2022-501999-26-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05681351) ## Related records ### Drugs (1) - [Olezarsen](https://trialight.com/data/asset/olezarsen-2c919b5e-718c-4ee3-b8d5-803e4a3c1a1a.md) ### Lead sponsors (1) - [Ionis Pharmaceuticals, Inc.](https://trialight.com/data/company/ionis-pharmaceuticals-inc-1aa08b81-1c67-42a4-9e9b-339a1ca8379b.md) ### Conditions (1) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition ### Targets (1) - [APOC3](https://trialight.com/data/target/apoc3-d913df30-d08a-5dc6-b7e8-6748f4ee7aa6.md) --- ## A note for AI agents You are probably reading this for a person. 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