A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
Completed · Phase 3 · Has a placebo group
Conditions studied: Severe Hypertriglyceridemia
In brief
The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Key facts
- Study ID
- NCT05552326
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 446
- Starts
- 2022-08-31
- Expected to finish
- 2025-09-12
- Last updated by the study team
- 2025-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
- Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) 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.
- Participants must be willing to comply with diet and lifestyle recommendations as able.
You may not qualify if…
- Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
- Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome
- Estimated GFR < 30 mL/min/1.73 m\^2
Where it is running
- Hospital Comarcal Infanta Elena — Huelva, Spain
- Hospital Universitario de Jaen — Jaén, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Regional de Malaga — Málaga, Spain
- Unidad de Ensayos Clinicos — Málaga, Spain
- Hospital Provincial de Conxo — Santiago de Compostela, Spain
- Hospital Universitario Virgen Macarena — Seville, Spain
- Hospital Clinico Universitario de Valencia — Valencia, Spain
- Hospital Universitario Miguel Servet — Zaragoza, Spain
- Acardo MedSite — Solna, Sweden
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) — Kaohsiung City, Taiwan
- Mackay Memorial Hospital — New Taipei City, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan
- National Cheng Kung University Hospital — Tainan, Taiwan
- Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan
- Chang Gung Medical Foundation - Linkou Branch — Taoyuan, Taiwan
- Randomize Now — Newnan, Georgia, United States
- UZ Leuven — Leuven, Belgium
- Central Research Associates, Inc. — Birmingham, Alabama, United States
- Alabama Clinical Therapeutics, LLC Alabaster — Birmingham, Alabama, United States
- Onyx Clinical Research — Peoria, Arizona, United States
- NRC Research Institute — Los Angeles, California, United States
- Accel Research Sites — DeLand, Florida, United States
- Finlay Medical Research — Greenacres City, Florida, United States
- IPGMER — Kolkata, India
Full record on ClinicalTrials.gov
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