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

• Status: Completed
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akcea Therapeutics; Ionis Pharmaceuticals, Inc.
• Collaborators: Akcea Therapeutics; Ionis Pharmaceuticals, Inc.

Criteria

Key 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.

Key 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.