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

Part of paid clinical trials in Lincoln, California.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05355402
Phase
PHASE2
Status
Completed

Conditions

  • Atherosclerotic Cardiovascular Disease
  • Hypertriglyceridemia
  • Severe Hypertriglyceridemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olezarsen — DRUG
    SC injection.
  • Placebo — DRUG
    SC injection.

Study Details

The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were 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).

Key Dates

Start date
May 9, 2022
Status verified
Apr 2026
Primary completion
Mar 22, 2023
Completion
Dec 21, 2023

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received olezarsen-matching placebo, as a single subcutaneous (SC) injection, once every 4 weeks for 53 weeks treatment period.
  • Experimental: Olezarsen 50 mg
    Participants received olezarsen 50 mg, as a single 0.5 milliliters (mL) SC injection, once every 4 weeks for 53 weeks treatment period.
  • Experimental: Olezarsen 80 mg
    Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.

Primary Outcome Measure

Percent Change From Baseline in Fasting TG at Month 6 [ Time Frame: Baseline, Month 6 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Clinical Trials ResearchLincolnCalifornia95648-
Catalina Research Institute, LLCMontclairCalifornia91763-
Excel Medical Clinical Trials, LLCBoca RatonFlorida33434-
De La Cruz Research CenterMiamiFlorida33184-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Research Physicians Network AllianceWinter ParkFlorida32792-
IACT HealthColumbusGeorgia31904-
Evanston Premier Healthcare ResearchEvanstonIllinois60201-
Clinical Investigation SpecialistGurneeIllinois60031-
West Broadway ClinicCouncil BluffsIowa51501-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
Aa Mrc, LlcFlintMichigan48504-
Clinical Research of South NevadaLas VegasNevada89121-
Palm Research Center, Inc.Las VegasNevada89148-
Green and Seidner Family Practice AssociatesLansdalePennsylvania19446-
Main Street Physicians Care WaterwayLittle RiverSouth Carolina29566-
Health ConceptsRapid CitySouth Dakota57702-
Tennessee Center for Clinical TrialsTullahomaTennessee37388-
Southern Endocrinology AssociatesMesquiteTexas75149-
Manassas Clinical Research CenterManassasVirginia20110-
York Clinical Research LLCNorfolkVirginia23504-

Related coverage on Hipa.ai

Find similar trials in Lincoln, CA

By research site
Clinical Trials Research· Lincoln, CACatalina Research Institute, LLC· Montclair, CAExcel Medical Clinical Trials, LLC· Boca Raton, FLDe La Cruz Research Center· Miami, FLSuncoast Clinical Research, Inc.· New Port Richey, FLResearch Physicians Network Alliance· Winter Park, FL

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