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A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT05552326
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: Olezarsen Drug: Placebo Phase 3

Detailed Description:

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in up to approximately 390 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.

The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : July 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
 Drug: Olezarsen
Olezarsen will be administered by SC injection.
Other Names:
  • ISIS 678354
  • AKCEA-APOCIII-LRx
Placebo Comparator: Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
 Drug: Placebo
Olezarsen-matching placebo will be administered by SC injection.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo [ Time Frame: Baseline and Month 6 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) Compared to Placebo [ Time Frame: Baseline and Month 12 ]
  2. Proportion of Participants Who Achieve Fasting TG Less Than (<) 500 milligrams per deciliter (mg/dL) (5.7 millimoles per liter [mmol/L]) at 6 and 12 Months Compared to Placebo [ Time Frame: Month 6 and Month 12 ]
  3. Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) at 6 and 12 Months Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL [ Time Frame: Month 6 and Month 12 ]
  4. Percentage of Participants Achieving Fasting TG < 1000 mg/dL in Participants with Baseline TG ≥ 1000 mg [ Time Frame: Month 6 and Month 12 ]
  5. Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III) at 6 and 12 Months Compared to Placebo [ Time Frame: Baseline, Month 6 and Month 12 ]
  6. Percent Change from Baseline in Fasting Very Low-Density Lipoprotein Cholesterol (VLDL-C) at 6 and 12 Months Compared to Placebo [ Time Frame: Baseline, Month 6 and 12 ]
  7. Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at 6 and 12 Months Compared to Placebo [ Time Frame: Baseline, Month 6 and 12 ]
  8. Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at 6 and 12 Months Compared to Placebo [ Time Frame: Baseline, Month 6 and 12 ]
  9. Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment [ Time Frame: Week 1 through Week 53 ]
  10. Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment [ Time Frame: Week 13 through Week 53 ]
  11. Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo [ Time Frame: Week 1 through Week 53 ]
  12. Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo [ Time Frame: Week 13 through Week 53 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
  2. 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.
  3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

  1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome
  4. Estimated GFR < 30 mL/min/1.73 m^2
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05552326


Contacts
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Contact: Ionis Pharmaceuticals 844-366-0213 ionisSHTG2study@clinicaltrialmedia.com

Locations
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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information
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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05552326    
Other Study ID Numbers: ISIS 678354-CS6
2022-501420-20 ( EudraCT Number )
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ionis Pharmaceuticals, Inc.:
Hypertriglyceridemia
Hyperlipidemias
Metabolic Diseases
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases