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Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease

NCT03070782 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2020-10-30

Study results available
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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

DRUG

ISIS 681257

ISIS 681257 solution for SC injection.

DRUG

Placebo

Sterile normal saline (0.9% NaCl)

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Akcea Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2018-07-26
Completion
2018-11-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070782 on ClinicalTrials.gov