NCT03070782PHASE2COMPLETED

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)

Sponsor: Akcea Therapeutics + Ionis Pharmaceuticals, Inc.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Elevated Lipoprotein(a), Cardiovascular Disease

Interventions

ISIS 681257, Placebo

Enrollment

286 participants

Primary completion

Jul 2018

Study completion

Nov 2018

First posted

Mar 2017

Last updated

Oct 2020

Primary Endpoints (CT.gov)

Percent Change From Baseline in Fasting Lipoprotein A [Lp(a)] at the Primary Analysis Time Point

Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)

Number of Participants With TEAEs by Maximum Severity

Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)

Number of Participants With TEAEs Leading to Study Discontinuation

Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)

Secondary Endpoints

Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C)

Percentage of Participants Who Achieved Plasma Lp(a) ≤ 125 Nanomoles Per Liter (Nmol/L) or ≤ 50 Milligrams Per Deciliter (mg/dL)

Percentage of Participants Who Achieved Plasma Lp(a) ≤ 75 Nmol/L or ≤ 30 mg/dL

Eligibility 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

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov