A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05079919
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
- Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled study in 617 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 617
- Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
- Patients 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.
Key
- Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
- Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
- Estimated GFR < 30 mL/min/1.73 m^2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olezarsen Olezarsen Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49. Placebo Placebo Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting TG Compared to Placebo Baseline and Month 6
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting TG Compared to Placebo Baseline and Month 12 Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo Baseline, Month 6 and 12 Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL Month 12 Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo Week 1 through Week 53 Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo Month 12 Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo Baseline through Month 12
Trial Locations
- Locations (201)
Accel Research Sites Network
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Velocity Clinical Research
🇺🇸Cedar Park, Texas, United States
Diabetes/Lipid Management & Research Center
🇺🇸Huntington Beach, California, United States
University of California, San Diego (UCSD)
🇺🇸La Jolla, California, United States
LA Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
America Clinical Trials
🇺🇸Tarzana, California, United States
Excel Medical Clinical Trials, LLC
🇺🇸Boca Raton, Florida, United States
Southeast Clinical Research LLC
🇺🇸Chiefland, Florida, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Scroll for more (191 remaining)Accel Research Sites Network🇺🇸Birmingham, Alabama, United States