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Antisense Oligonucleotide

AKCEA-ANGPTL3-LRx 20 mg for Chylomicronemia Syndrome

Phase 2

Waitlist Available

Research Sponsored by Akcea Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

No Placebo-Only Group

Summary

This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of triglyceride (TG) levels in participants with FCS.

Eligible Conditions

Chylomicronemia Syndrome
Lipoprotein Lipase Deficiency
Hypercholesterolemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG)

Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG)

Secondary study objectives

Absolute Change From Baseline to Month 3 in Fasting Angiopoietin-Like 3 (ANGPTL3)

Absolute Change From Baseline to Month 3 in Other Fasting Lipid Parameters

Change From Baseline to Day 92 in Maximum Postprandial Triglycerides (TG)

+4 more

Side effects data

From 2018 Phase 2 trial • 3 Patients • NCT03360747

67%

Headache

33%

Vertigo positional

33%

Influenza

33%

Hyperlipidaemia

33%

Loss of libido

33%

Mood swings

33%

Asthenia

33%

Influenza like illness

33%

Back pain

33%

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

AKCEA-ANGPTL3-LRx 20 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AKCEA-ANGPTL3-LRx 20 mgExperimental Treatment1 Intervention

Participants received a subcutaneous (SC) injection of AKCEA-ANGPTL3-LRx, 20 milligrams (mg), weekly (QW) for 13-weeks of treatment period. Participants were followed up to Week 26.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AKCEA-ANGPTL3-LRx

2018

Completed Phase 2

~10

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