At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 286 enrolled
Drug / intervention
ISIS 681257 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) Administered Subcutaneously to Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease (CVD)
In Brief
A Phase 2 clinical trial evaluating ISIS 681257 and Placebo for Elevated Lipoprotein(a) and Cardiovascular Disease. Completed, enrolled 286 participants across 32 sites in 5 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a) \[Lp(a)\] levels in participants with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElevated Lipoprotein(a), Cardiovascular Disease
CountriesCanada, Denmark, Germany, Netherlands, United States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMar 2017
Primary CompletionJul 2018
Study CompletionNov 2018
TodayJul 2026
First PostedMar 6, 2017
Enrollment StartMar 7, 2017
Primary CompletionJul 26, 2018
Study CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.3 years ago
Interventions
ISIS 681257drug
ISIS 681257 solution for SC injection.
Placebodrug
Sterile normal saline (0.9% NaCl)