Back to resultsA 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
Primary Purpose
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Olezarsen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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
Sites / Locations
- Clinical Trials Research
- Catalina Research Institute, LLC
- Excel Medical Clinical Trials, LLC
- De La Cruz Research Center
- Suncoast Clinical Research, Inc.
- Research Physicians Network Alliance
- IACT Health
- Evanston Premier Healthcare Research
- Clinical Investigation Specialist
- West Broadway Clinic
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
- Aa Mrc, Llc
- Clinical Research of South Nevada
- Palm Research Center, Inc.
- Green and Seidner Family Practice Associates
- Main Street Physicians Care Waterway
- Health Concepts
- Tennessee Center for Clinical Trials
- Southern Endocrinology Associates
- Manassas Clinical Research Center
- York Clinical Research LLC
- Bluewater Clinical Research Group Inc
- Ecogene-21
- Clinique des Maladies Lipidiques de Quebec Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Olezarsen
Placebo
Arm Description
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline at Month 6 (average of Weeks 25 and 27) in Fasting Triglycerides (TG)
Secondary Outcome Measures
Percent Change From Baseline at Month 12 in Fasting TG
Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 milligrams per deciliter (mg/dL) (1.69 millimoles per liter [mmol/L]) at Month 6
Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 mg/dL (1.69 mmol/L) at Month 12
Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL (5.65 mmol/L) at Month 6
Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL at Month 12
Percent Change From Baseline at Months 6 and 12 in Fasting apoC-III
Percent Change From Baseline at Months 6 and 12 in Fasting VLDL-C
Percent Change From Baseline at Months 6 and 12 in Fasting Remnant Cholesterol
Percent Change From Baseline at Months 6 and 12 in Fasting Non-HDL-C
Percent Change From Baseline at Months 6 and 12 in Fasting HDL-C
Percent Change From Baseline at Months 6 and 12 in Fasting TC
Percent Change From Baseline at Months 6 and 12 in Fasting apoB
Percent Change From Baseline at Months 6 and 12 in Fasting LDL-C
Percent Change From Baseline at Months 6 and 12 in apoA-1
Full Information
NCT ID
NCT05355402
First Posted
April 26, 2022
Last Updated
August 21, 2023
Sponsor
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05355402
Brief Title
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
Official Title
A Randomized, Double-blind, Placebo-Controlled, Phase 2b Study of ISIS 678354 in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
March 22, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 achieve different thresholds in fasting TG. Another objective is to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).
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]) and established or at increased risk for atherosclerotic cardiovascular disease, and/or with severe hypertriglyceridemia. The study will have an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Olezarsen
Arm Type
Experimental
Arm Description
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Intervention Type
Drug
Intervention Name(s)
Olezarsen
Other Intervention Name(s)
ISIS 678354, AKCEA-APOCIII-LRx
Intervention Description
Olezarsen will be administered by SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline at Month 6 (average of Weeks 25 and 27) in Fasting Triglycerides (TG)
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Percent Change From Baseline at Month 12 in Fasting TG
Time Frame
Baseline and Month 12
Title
Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 milligrams per deciliter (mg/dL) (1.69 millimoles per liter [mmol/L]) at Month 6
Time Frame
Baseline and Month 6
Title
Proportion of Participants with Baseline TG < 500 mg/dL (5.65 mmol/L) Who Achieve Fasting TG < 150 mg/dL (1.69 mmol/L) at Month 12
Time Frame
Baseline and Month 12
Title
Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL (5.65 mmol/L) at Month 6
Time Frame
Baseline and Month 6
Title
Proportion of Participants with Baseline TG ≥ 500 mg/dL Who Achieve Fasting TG < 500 mg/dL at Month 12
Time Frame
Baseline and Month 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting apoC-III
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting VLDL-C
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting Remnant Cholesterol
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting Non-HDL-C
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting HDL-C
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting TC
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting apoB
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in Fasting LDL-C
Time Frame
Baseline, Months 6 and 12
Title
Percent Change From Baseline at Months 6 and 12 in apoA-1
Time Frame
Baseline, Months 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
De La Cruz Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Research Physicians Network Alliance
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Evanston Premier Healthcare Research
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Investigation Specialist
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
West Broadway Clinic
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Aa Mrc, Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Green and Seidner Family Practice Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Main Street Physicians Care Waterway
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Tennessee Center for Clinical Trials
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
York Clinical Research LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23504
Country
United States
Facility Name
Bluewater Clinical Research Group Inc
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7t 4X3
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Clinique des Maladies Lipidiques de Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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