NCT03385239

Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)

A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Akcea Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with hypertriglyceridemia and established CVD or at a high risk for CVD.

Conditions

• Hypertriglyceridemia
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	ISIS 678354	ISIS 678354 solution for SC injection.
DRUG	Placebo	Sterile Normal Saline (0.9% NaCl).

Timeline

• Start date: 2018-01-30
• Primary completion: 2019-11-25
• Completion: 2020-02-25
• First posted: 2017-12-28
• Last updated: 2023-01-11
• Results posted: 2023-01-11

Locations

31 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study