Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2018-09-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Familial Chylomicronemia Syndrome Lipoprotein Lipase Deficiency Hyperlipoproteinemia Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AKCEA-ANGPTL3-LRx 20 mg

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.

Group Type EXPERIMENTAL

AKCEA-ANGPTL3-LRx

Intervention Type DRUG

AKCEA-ANGPTL3-LRx at dose 20 mg, administered via SC injection QW.

Interventions

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AKCEA-ANGPTL3-LRx

AKCEA-ANGPTL3-LRx at dose 20 mg, administered via SC injection QW.

Intervention Type DRUG

Other Intervention Names

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ISIS 703802 IONIS-ANGPTL3-LRx Vupanorsen

Eligibility Criteria

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Inclusion Criteria

* Genetically confirmed chylomicronemia syndrome.
* Fasting triglycerides greater than or equal to (\>=) 750 milligrams per deciliter (mg/dL) \[8.4 millimoles per liter (mmol/L)\] at Screening.

Exclusion Criteria

* Diabetes mellitus if newly diagnosed or if glycated hemoglobin (HbA1c) \>= 9.0%.
* Active pancreatitis within 2 weeks of screening.
* Acute coronary syndrome within 6 months of screening.
* Major surgery within 3 months of screening.
* Treatment with Glybera therapy within 2 years of screening.
* Previous treatment with AKCEA-ANGPTL3-LRx.
* Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No