Trials / Completed
CompletedNCT03070782
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 286 (actual)
- Sponsor
- Akcea Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISIS 681257 | ISIS 681257 solution for SC injection. |
| DRUG | Placebo | Sterile normal saline (0.9% NaCl) |
Timeline
- Start date
- 2017-03-07
- Primary completion
- 2018-07-26
- Completion
- 2018-11-13
- First posted
- 2017-03-06
- Last updated
- 2020-10-30
- Results posted
- 2020-10-30
Locations
32 sites across 5 countries: United States, Canada, Denmark, Germany, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03070782. Inclusion in this directory is not an endorsement.