Severe Hypertriglyceridemia Clinical Trial
Official title:
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | September 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment. - Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. 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. NOTE: Other Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | |
| Australia | Royal Prince Alfred Hospital | Camperdown | |
| Australia | Royal North Shore Hospital | Saint Leonards | New South Wales |
| Australia | Dr Heart Pty Ltd | Woolloongabba | |
| Bulgaria | Medical Center Doctor Staykov EOOD | Burgas | |
| Bulgaria | Medical Center Diamedical 2013 OOD | Dimitrovgrad | |
| Bulgaria | Medical Center Smolyan Clinical Research OOD | Smolyan | |
| Bulgaria | Medical Center Endomedical | Sofia | |
| Bulgaria | Clinical of Cardiology | Stara Zagora | |
| Bulgaria | Medical Centre "Nevromedics" EOOD | Veliko Tarnovo | |
| Canada | Ecogene-21 | Chicoutimi | Quebec |
| Canada | Clinique des Maladies Lipidiques de Quebec Inc. | Québec | Quebec |
| Canada | Canadian Phase Onward Inc. | Toronto | Ontario |
| Czechia | MEDICUS SERVICES s.r.o. | Brandýs Nad Labem | |
| Czechia | EDUMED s.r.o. | Náchod | |
| Czechia | Fakultni nemocnice Ostrava | Ostrava | |
| Czechia | Vseobecna fakultni nemocnice | Prague | |
| Czechia | MU Dr. Nina Zemkova s.r.o. Interni Ambulance | Uherské Hradište | |
| Denmark | Aalborg University Hospital | Aalborg | |
| Denmark | Aarhus Universitet Hospital | Aarhus | |
| Denmark | Esbjerg Hospital | Esbjerg | |
| Denmark | Viborg Regional Hospital | Viborg | |
| France | Louis Pradel Hospital | Bron | |
| France | Hôpitaux de Marseille | Marseille | |
| France | CHU de Nantes - Hôpital Nord Laennec | Saint-Herblain | |
| Hungary | DRC Gyógyszervizsgáló Központ Korlátolt felelosségu társaság Balatonfüred | Balatonfüred | |
| Hungary | Debreceni Egyetem Klinikai Központ | Debrecen | |
| Hungary | Kardiologia Szakrendeles | Nyíregyháza | |
| Hungary | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | |
| Israel | The Lady Davis Carmel Medical Center | Haifa | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Rabin Medical Center | Petach Tikva | |
| Italy | Ospdale E. Bassini | Milano | |
| Netherlands | Academic Medical Center | Amsterdam | |
| Netherlands | Ziekenhuis Rijnstate | Arnhem | |
| Netherlands | Ziekenhuis Gelderse Vallei | Ede | |
| Netherlands | Radboud UMC | Nijmegen | |
| Netherlands | University Medical Center Utrecht | Utrecht | |
| New Zealand | New Zealand Clinical Research | Auckland | |
| Norway | The Lipid Clinic (Oslo University Hospital) | Oslo | |
| Poland | Przychodnia Futuremeds Wroclaw | Wroclaw | |
| Slovakia | Kardiologická ambulancia | Brezno | |
| Slovakia | Cardio D&R, S.R.O. Kosice | Košice | |
| South Africa | Latros International | Bloemfontein | |
| South Africa | Medi Clinic Vergelegen | Cape Town | |
| South Africa | TREAD Research | Cape Town | |
| South Africa | University of Cape Town | Cape Town | |
| Spain | Hospital Clinic De Barcelona | Barcelona | |
| Spain | Hospital Universitari de Bellvitge | Barcelona | |
| Spain | Hospital Universitario Reina Sofia | Córdoba | |
| Spain | Hospital Abente y Lago | La Coruna | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Corporacio Sanitaria Parc Tauli- Hospital de Sabadell | Sabadell | |
| Spain | Hospital Virgen del Rocío | Sevilla | |
| Spain | Hospital Universitari Sant Joan de Reus | Tarragona | |
| Sweden | Sahlgrenska, University Hospital | Göteborg | |
| Sweden | Karolinska University Hospital Huddinge | Stockholm | |
| United States | University of Michigan- Endocrinology & Metabolism | Ann Arbor | Michigan |
| United States | Excel Medical Clinical Trials | Boca Raton | Florida |
| United States | Grace Research, LLC | Bossier City | Louisiana |
| United States | The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute | Charlotte | North Carolina |
| United States | Centricity Research | Columbus | Georgia |
| United States | IACT Health | Columbus | Georgia |
| United States | University of Texas Southwestern | Dallas | Texas |
| United States | Central Oklahoma Early Detection Center | Edmond | Oklahoma |
| United States | Aa Mrc, Llc | Flint | Michigan |
| United States | Finlay Medical Research | Greenacres City | Florida |
| United States | Kenneth Hilty | Greensboro | North Carolina |
| United States | Juno Research | Houston | Texas |
| United States | Pioneer Research Solutions | Houston | Texas |
| United States | University of Kansas Medical Center (KUMC) | Kansas City | Kansas |
| United States | Clinical Trials of America, LLC | Lenoir | North Carolina |
| United States | Walker Family Care | Little River | South Carolina |
| United States | Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky |
| United States | Manassas Clinical Research | Manassas | Virginia |
| United States | Texas Institute of Cardiology | McKinney | Texas |
| United States | SMS Clinical Research, LLC | Mesquite | Texas |
| United States | Southern Endocrinology Associates | Mesquite | Texas |
| United States | Columbus Clinical Services, LLC | Miami | Florida |
| United States | Finlay Medical Research | Miami | Florida |
| United States | WVU Heart and Vascular Institute | Morgantown | West Virginia |
| United States | York Clinical Research | Norfolk | Virginia |
| United States | Affinity Health | Oak Brook | Illinois |
| United States | Permian Research Foundation | Odessa | Texas |
| United States | Health Concepts | Rapid City | South Dakota |
| United States | Washington School of Medicine | Saint Louis | Missouri |
| United States | R & B Medical Center LLC | Tampa | Florida |
| United States | Metabolic Institute of America | Tarzana | California |
| United States | IRC Clinics | Towson | Maryland |
| United States | Bayside Clinical Research | Trinity | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Ionis Pharmaceuticals, Inc. |
United States, Australia, Bulgaria, Canada, Czechia, Denmark, France, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53 | Baseline up to Week 53 | ||
| Primary | Proportion of Participants Who Experience Adverse Events (AEs) | Up to 66 weeks | ||
| Primary | Proportion of Participants Who Use Concomitant Medications | Up to 66 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01208961 -
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
|
Phase 2 | |
| Completed |
NCT04541186 -
Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
|
Phase 2 | |
| Active, not recruiting |
NCT05079919 -
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT02189252 -
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
|
Phase 1 | |
| Active, not recruiting |
NCT01229566 -
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT03001817 -
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
|
Phase 3 | |
| Completed |
NCT03011450 -
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT05355402 -
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
|
Phase 2 | |
| Completed |
NCT04720534 -
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
|
Phase 2 | |
| Recruiting |
NCT06347016 -
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
|
Phase 3 | |
| Recruiting |
NCT06347003 -
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
|
Phase 3 | |
| Withdrawn |
NCT04662528 -
Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
|
Phase 3 | |
| Recruiting |
NCT05852431 -
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
|
Phase 3 | |
| Completed |
NCT01242527 -
Epanova® for Lowering Very High Triglycerides
|
Phase 2/Phase 3 | |
| Completed |
NCT02944383 -
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
|
Phase 2 | |
| Recruiting |
NCT05552326 -
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
|
Phase 3 | |
| Withdrawn |
NCT01997268 -
The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)
|
Phase 3 |