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

A

Akcea Therapeutics

Status and phase

Completed
Phase 2

Conditions

Elevated Lipoprotein(a)
Cardiovascular Disease

Treatments

Drug: ISIS 681257
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03070782
2016-003373-18 (EudraCT Number)
ISIS 681257-CS6

Details and patient eligibility

About

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).

Enrollment

286 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or peripheral artery disease
  • Lp(a) plasma level ≥ 60 mg/dL
  • Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD risk factors

Key Exclusion Criteria:

  • Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/TIA
  • Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis
  • Heart failure New York Heart Association (NYHA) class IV

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

286 participants in 6 patient groups, including a placebo group

Cohort A: ISIS 681257: 20 mg Q4W
Experimental group
Description:
Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
Treatment:
Drug: ISIS 681257
Cohort B: ISIS 681257: 40 mg Q4W
Experimental group
Description:
Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
Treatment:
Drug: ISIS 681257
Cohort C: ISIS 681257: 60 mg Q4W
Experimental group
Description:
Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
Treatment:
Drug: ISIS 681257
Cohort D: ISIS 681257: 20 mg Q2W
Experimental group
Description:
Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
Treatment:
Drug: ISIS 681257
Cohort E: ISIS 681257: 20 mg QW
Experimental group
Description:
Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
Treatment:
Drug: ISIS 681257
Placebo
Placebo Comparator group
Description:
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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