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

NCT05610280
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Completed
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Participants
1,478
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Lead sponsor
Ionis Pharmaceuticals, Inc.
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Start date
2022-11-21
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Number of sites
168
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Summary
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
clinicaltrials.gov
Short title
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
clinicaltrials.gov
Official title
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-06-09
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First posted
2022-11-09
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Registry last updated
2026-02-10
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Primary completion date
2024-08-08
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Start date
2022-11-21
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Actual participants
1,478
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Participants
1,478
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
168
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Ionis Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05610280
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05610280
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent Change From Baseline to Week 25 in Fasting Triglycerides (TG) Compared to Placebo

    Timeframe: Baseline to Week 25

  1. Percent Change From Baseline to Week 53 in Fasting TG Compared to Placebo

    Timeframe: Baseline to Week 53

  2. Proportion of Participants who Achieve Fasting TG <150 Milligrams per Deciliter (mg/dL) at Weeks 25 and 53 Compared to Placebo

    Timeframe: Baseline, Weeks 25 and 53

  3. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein C-III (apoC-III) Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  4. Percent Change From Baseline to Weeks 25 and 53 in Fasting Very Low-Density Lipoprotein-Cholesterol (VLDL)-C Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  5. Percent Change From Baseline to Weeks 25 and 53 in Fasting Remnant Cholesterol Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  6. Percent Change From Baseline to Weeks 25 and 53 in Fasting non-High Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  7. Percent Change From Baseline to Weeks 25 and 53 in Fasting High-Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  8. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B (apoB) Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

  9. Percent Change From Baseline to Weeks 25 and 53 in Fasting Low-Density Lipoprotein-Cholesterol (LDL)-C Compared to Placebo

    Timeframe: Baseline to Weeks 25 and 53

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants must fall into 1 of the following groups (a or b):

    a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 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

    b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)

  • Participants should be on standard of care (SOC) lipid-lowering medications 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.

  • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  • Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  • Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome
  • Estimated GFR < 30 mL/min/1.73 m^2

NOTE: Other Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • Alabama Clinical Therapeutics, LLC AlabasterBirmingham, United States
  • Heart Center Research PCHuntsville, United States
  • Cardiovascular Research Foundation of Southern CaliforniaBeverly Hills, United States
  • Westside Medical Associates of Los AngelesBeverly Hills, United States
  • Diabetes/Lipid Management & Research CenterHuntington Beach, United States
  • University of California, San Diego (UCSD)La Jolla, United States
  • Clinical Trials ResearchLincoln, United States
  • Amicis ResearchNorthridge, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Northern California ResearchSacramento, United States
  • Amicis Research CenterSanta Clarita, United States
  • Metabolic Institute of AmericaTarzana, United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorrance, United States
  • Amicis Research CenterValencia, United States
  • Excel Clinical Medical TrialsBoca Raton, United States
  • Finlay Medical Research - West PalmGreenacres City, United States
  • Global Research AssociatesHomestead, United States
  • 3Sync ResearchLake Worth, United States
  • Finlay Medical ResearchMiami, United States
  • Advanced Medical Research Institute (AMRI)Miami, United States
  • De La Cruz Research Center, LLMiami, United States
  • Suncoast Clinical Research, Inc. - New Port RicheyNew Port Richey, United States
  • Suncoast Clinical Research, Inc. - Palm HarborNew Port Richey, United States
  • Proactive Clinical ResearchOakland Park, United States
  • Ocala Cardiovascular ResearchOcala, United States

And 143 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-501486-53
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)