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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

32 sites in 5 countries.

About this study

Official title: 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)

Conditions

Elevated Lipoprotein(a), Cardiovascular Disease

Being tested

ISIS 681257, Placebo

Keywords

IONIS-APO(a)-LRx, AKCEA-APO(a)-LRx, Dyslipidemia, Dyslipoproteinemia, Hyperlipidemia, Hyperlipoproteinemia, Hyperlipoproteinemia(a), Hyperlipoproteinemia a, Lipoprotein, Lipoprotein(a), Lipoprotein a, Lp(a), Lp a

Medical subject headings

Cardiovascular Diseases, Dyslipidemias, Hyperlipidemias, Hyperlipoproteinemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ISIS 681257Drug

  Also called AKCEA-APO(a)-LRx, IONIS-APO(a)-LRx, TQJ230 and Pelacarsen

  ISIS 681257 solution for SC injection.

• PlaceboDrug

  Sterile normal saline (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   An ANCOVA model was performed on the log ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline - 1) × 100.

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

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

   An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.

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

3. Number of Participants With TEAEs by Maximum Severity

   An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. The severity of TEAEs was assessed based on the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.

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

4. Number of Participants With TEAEs Leading to Study Discontinuation

   An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAE was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Mar 2017
2. Study start7 Mar 2017
3. Primary completion26 Jul 2018
4. Study completion13 Nov 2018

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Elevated Lipoprotein(a)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.