MedPath

Olezarsen

Generic Name
Olezarsen

Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)

Conditions
Familial Chylomicronemia Syndrome
First Posted Date
2024-04-11
Last Posted Date
2024-12-27
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Registration Number
NCT06360237
Locations
🇺🇸

Expanded Access Site, Carlsbad, California, United States

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Phase 3
Recruiting
Conditions
Severe Hypertriglyceridemia
Interventions
First Posted Date
2023-01-12
Last Posted Date
2025-05-01
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
800
Registration Number
NCT05681351
Locations
🇪🇸

Hospital Universitario de Jaen, Jaén, Spain

🇪🇸

Hospital Abente y Lago, La Coruna, Spain

🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

and more 251 locations

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Phase 3
Active, not recruiting
Conditions
Cardiovascular Diseases
Hypertriglyceridemia
Atherosclerosis
Interventions
Drug: Placebo
First Posted Date
2022-11-09
Last Posted Date
2025-04-09
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
1478
Registration Number
NCT05610280
Locations
🇮🇹

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Rome, Italy

🇳🇱

Universitair Medisch Centrum Utrecht, Utrecht, Netherlands

🇵🇱

FutureMeds Sp. z o.o, Wrocław, Poland

and more 163 locations

A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-10-14
Last Posted Date
2024-05-10
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
104
Registration Number
NCT05579860
Locations
🇺🇸

Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, United States

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Phase 3
Active, not recruiting
Conditions
Severe Hypertriglyceridemia
Interventions
Drug: Placebo
First Posted Date
2022-09-23
Last Posted Date
2025-01-29
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
446
Registration Number
NCT05552326
Locations
🇺🇸

Clinical Investigation Specialists Inc., Kenosha, Wisconsin, United States

🇺🇸

NRC Research Institute, Los Angeles, California, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

and more 199 locations

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
Conditions
Hypertriglyceridemia
Atherosclerotic Cardiovascular Disease
Severe Hypertriglyceridemia
Interventions
Drug: Placebo
First Posted Date
2022-05-02
Last Posted Date
2024-11-27
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
154
Registration Number
NCT05355402
Locations
🇺🇸

Main Street Physicians Care Waterway, Little River, South Carolina, United States

🇨🇦

Ecogene-21, Chicoutimi, Quebec, Canada

🇨🇦

Clinique des Maladies Lipidiques de Quebec Inc., Quebec, Canada

and more 21 locations

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

Phase 3
Active, not recruiting
Conditions
Familial Chylomicronemia Syndrome
Interventions
First Posted Date
2022-01-11
Last Posted Date
2024-12-04
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT05185843
Locations
🇨🇦

Ecogene-21, Chicoutimi, Quebec, Canada

🇨🇦

Centre Hospitalier Universite de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada

🇺🇸

Diabetes/Lipid Management & Research Center, Huntington Beach, California, United States

and more 8 locations

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

Phase 3
Active, not recruiting
Conditions
Familial Chylomicronemia Syndrome
Interventions
First Posted Date
2021-11-23
Last Posted Date
2025-03-04
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
60
Registration Number
NCT05130450
Locations
🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

🇺🇸

University of Kansas Medical Center (KUMC), Kansas City, Kansas, United States

🇺🇸

IDS Central, Philadelphia, Pennsylvania, United States

and more 24 locations

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Phase 3
Active, not recruiting
Conditions
Severe Hypertriglyceridemia
Interventions
Drug: Placebo
First Posted Date
2021-10-15
Last Posted Date
2025-01-29
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
617
Registration Number
NCT05079919
Locations
🇺🇸

Excel Medical Clinical Trials, LLC, Boca Raton, Florida, United States

🇿🇦

Dr Jan Engelbrecht and Ass. Inc, Cape Town, Western Cape, South Africa

🇳🇱

Albert Schweitzer ziekenhuis, Dordrecht, Netherlands

and more 198 locations

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

Phase 3
Completed
Conditions
Familial Chylomicronemia Syndrome
Interventions
Drug: Placebo
First Posted Date
2020-09-29
Last Posted Date
2025-03-06
Lead Sponsor
Ionis Pharmaceuticals, Inc.
Target Recruit Count
66
Registration Number
NCT04568434
Locations
🇵🇹

Hospital da Senhora da Oliveira - Guimaraes, Creixomil, Portugal

🇳🇱

Universitair Medisch Centrum Utrecht, Utrecht, Netherlands

🇳🇴

The Lipid Clinic (Oslo University Hospital), Oslo, Norway

and more 44 locations
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