A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

Conditions

• Familial Chylomicronemia Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olezarsen — DRUG
  Olezarsen was administered by SC injection.
• Placebo — DRUG
  Olezarsen-matching placebo was administered by SC injection.

Study Details

The purpose of the study was to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Key Dates

Start date

Nov 18, 2020

Status verified

Feb 2025

Primary completion

Jul 14, 2023

Completion

Oct 17, 2023

Study Design

Enrollment

66 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received olezarsen-matching placebo, once every 4 weeks by subcutaneous (SC) injection, during Weeks 1 to 49 of the 53-week treatment period.
• Experimental: Olezarsen 50 mg
  Participants received olezarsen, 50 milligrams (mg), once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period.
• Experimental: Olezarsen 80 mg
  Participants received olezarsen 80 mg, once every 4 weeks by SC injection, during Weeks 1 to 49 of the 53-week treatment period.

Primary Outcome Measure

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

Locations (17)

Related coverage on Hipa.ai

• Olezarsen Phase 3 Trial Reduces Triglycerides in FCS Patients
  Olezarsen · Mar 6, 2025 · ClinicalTrials.gov

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