Clinical Trials in Poland / NCT05681351
Active, not recruiting
Phase 3
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
NCT05681351 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Severe Hypertriglyceridemia
Study summary
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
Eligibility
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.
Primary outcome measure(s)
- 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 — Baseline up to Week 157
- Proportion of Participants Who Experience Adverse Events (AEs) — Baseline up to Week 157
- Proportion of Participants Who Use Concomitant Medications — Baseline up to Week 157
Trial sites (262)
| Facility | City | Region | Status |
|---|---|---|---|
| LA Universal Research Center, Inc. | Los Angeles | California | |
| University of California, San Diego (UCSD) | San Diego | California | |
| Metabolic Institute of America | Tarzana | California | |
| Excel Medical Clinical Trials | Boca Raton | Florida | |
| Finlay Medical Research | Greenacres City | Florida | |
| Columbus Clinical Services, LLC | Miami | Florida | |
| Finlay Medical Research | Miami | Florida | |
| Innovia Research Center, Inc. | Miramar | Florida | |
| Harmony Clinical Research, Inc. | North Miami Beach | Florida | |
| R & B Medical Center LLC | Tampa | Florida | |
| VICIS Clinical Research | Tampa | Florida | |
| JSV Clinical Research Study, Inc. | Tampa | Florida | |
| Bayside Clinical Research | Trinity | Florida | |
| Centricity Research | Columbus | Georgia | |
| IACT Health | Columbus | Georgia | |
| Affinity Health | Oak Brook | Illinois | |
| St. Vincent Medical Group, Inc. | Carmel | Indiana | |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | |
| The Research Group of Lexington, LLC | Lexington | Kentucky | |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | |
| Grace Research, LLC | Bossier City | Louisiana | |
| University of Maryland School of Medicine | Baltimore | Maryland | |
| IRC Clinics | Towson | Maryland | |
| Massachusetts General Hospital Heart Center | Boston | Massachusetts | |
| University of Michigan- Endocrinology & Metabolism | Ann Arbor | Michigan | |
| Aa Mrc, Llc | Flint | Michigan | |
| Washington School of Medicine | St Louis | Missouri | |
| Bryan Medical Center | Lincoln | Nebraska | |
| Palm Research Center, Inc. | Las Vegas | Nevada | |
| Hudson County Clinical Trials Research Center | Union City | New Jersey | |
| Modern Medical | Brooklyn | New York | |
| NYU Langone Health | Mineola | New York | |
| Langone Medical Center | New York | New York | |
| Vagelos College of Physicians and Surgeons of Columbia University | New York | New York | |
| Orchard Park Family Practice | Orchard Park | New York | |
| The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute | Charlotte | North Carolina | |
| Kenneth Hilty | Greensboro | North Carolina | |
| Clinical Trials of America, LLC | Lenoir | North Carolina | |
| Lexington | Winston-Salem | North Carolina | |
| The Ohio State University | Columbus | Ohio |
+ 222 more sites — see the full list on the official registry below.
More Ionis Pharmaceuticals, Inc. trials in Poland
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
Active, not recruiting
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)
Active, not recruiting
REVEAL: A Phase 3 Study of Obudanersen (ION582) in Angelman Syndrome
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05681351 on ClinicalTrials.gov ↗ ← All trials in Poland