Status:
COMPLETED
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
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypertriglyceridemia
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the percentage of participants who achi...
Detailed Description
This will be a multi-center, randomized, double-blind, placebo-controlled study in approximately 152 participants with hypertriglyceridemia (triglycerides \> 150 milligrams per deciliter \[mg/dL\]) an...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years at the time of informed consent
- Fall into at least 1 of the following groups (a or b):
- Hypertriglyceridemia with fasting TG ≥ 150 mg/dL (1.69 millimoles per liter \[mmol/L\]) and \< 500 mg/dL (5.65 mmol/L) with either clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or at increased risk for ASCVD
- Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L).
- Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines.
- Participants must be willing to comply with diet and lifestyle recommendations as able.
Exclusion
- Diabetes with any of the following:
- Newly diagnosed within 12 weeks of screening
- Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening
- Change in basal insulin regimen \> 20% within 3 months prior to Screening
- For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening
- Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening
- Major surgery, peripheral revascularization, or non-urgent percutaneous coronary intervention (PCI) within 3 months prior to Screening, or upcoming planned major surgery or major procedure (e.g., arterial revascularization) during the course of the study
- Active pancreatitis within 4 weeks prior to Screening
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05355402
Start Date
May 9 2022
End Date
December 21 2023
Last Update
November 27 2024
Active Locations (24)
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1
Clinical Trials Research
Lincoln, California, United States, 95648
2
Catalina Research Institute, LLC
Montclair, California, United States, 91763
3
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States, 33434
4
De La Cruz Research Center
Miami, Florida, United States, 33184