Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT03070782 |
Recruitment Status :
Completed
First Posted : March 6, 2017
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
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Sponsor:
Akcea Therapeutics
Collaborator:
Ionis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Akcea Therapeutics
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Elevated Lipoprotein(a) Cardiovascular Disease |
Interventions |
Drug: ISIS 681257 Drug: Placebo |
Enrollment | 286 |
Participant Flow
Recruitment Details | Participants with a clinical diagnosis of hyperlipoproteinemia(a) and established CVD were enrolled in 31 study centers in United States, Canada, Denmark, Germany and Netherlands between 7th March 2017 to 13th November 2018. |
Pre-assignment Details | 286 participants were randomized in a 1:1:1:1:1 ratio to Cohorts A, B, C, D or E. In each cohort, participants were randomized in a 5:1 ratio to receive ISIS 681257 or placebo. |
Arm/Group Title | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
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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. | Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses. | Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses. | 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. | 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. | Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257). |
Period Title: Overall Study | ||||||
Started | 48 | 48 | 47 | 48 | 48 | 47 |
Completed [1] | 41 | 47 | 43 | 43 | 36 | 40 |
Not Completed | 7 | 1 | 4 | 5 | 12 | 7 |
Reason Not Completed | ||||||
Adverse Event | 3 | 0 | 3 | 1 | 6 | 2 |
Withdrawal by Subject | 2 | 1 | 1 | 0 | 4 | 3 |
Reason Not Specified | 2 | 0 | 0 | 1 | 2 | 1 |
Ineligibility | 0 | 0 | 0 | 1 | 0 | 1 |
Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 |
Investigator Judgement | 0 | 0 | 0 | 1 | 0 | 0 |
[1]
Completed here refers to participants who completed study treatment.
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Baseline Characteristics
Arm/Group Title | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo | Total | |
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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. | Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses. | Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses. | 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. | 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. | Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257). | Total of all reporting groups | |
Overall Number of Baseline Participants | 48 | 48 | 47 | 48 | 48 | 47 | 286 | |
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Safety Set included all participants who were randomized and received at least 1 dose of study drug (ISIS 681257 or placebo).
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 48 participants | 48 participants | 47 participants | 48 participants | 48 participants | 47 participants | 286 participants | |
60.0
(38 to 77)
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61.3
(39 to 80)
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62.2
(40 to 79)
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57.9
(30 to 76)
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58.9
(40 to 75)
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59.9
(34 to 76)
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60.0
(30 to 80)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 48 participants | 48 participants | 47 participants | 48 participants | 48 participants | 47 participants | 286 participants | |
Female |
19 39.6%
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12 25.0%
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14 29.8%
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17 35.4%
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20 41.7%
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15 31.9%
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97 33.9%
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Male |
29 60.4%
|
36 75.0%
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33 70.2%
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31 64.6%
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28 58.3%
|
32 68.1%
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189 66.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 48 participants | 48 participants | 47 participants | 48 participants | 48 participants | 47 participants | 286 participants | |
Hispanic or Latino |
2 4.2%
|
1 2.1%
|
0 0.0%
|
0 0.0%
|
1 2.1%
|
1 2.1%
|
5 1.7%
|
|
Not Hispanic or Latino |
46 95.8%
|
47 97.9%
|
47 100.0%
|
48 100.0%
|
47 97.9%
|
46 97.9%
|
281 98.3%
|
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 48 participants | 48 participants | 47 participants | 48 participants | 48 participants | 47 participants | 286 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 2.1%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 2.1%
|
2 0.7%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
2 4.2%
|
3 6.3%
|
0 0.0%
|
0 0.0%
|
1 2.1%
|
0 0.0%
|
6 2.1%
|
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White |
44 91.7%
|
45 93.8%
|
47 100.0%
|
47 97.9%
|
47 97.9%
|
46 97.9%
|
276 96.5%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
1 2.1%
|
0 0.0%
|
0 0.0%
|
1 2.1%
|
0 0.0%
|
0 0.0%
|
2 0.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Study Director |
Organization: | Akcea Therapeutics |
Phone: | 617-207-0289 |
EMail: | clinicalstudies@akceatx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Akcea Therapeutics |
ClinicalTrials.gov Identifier: | NCT03070782 |
Other Study ID Numbers: |
ISIS 681257-CS6 2016-003373-18 ( EudraCT Number ) |
First Submitted: | January 31, 2017 |
First Posted: | March 6, 2017 |
Results First Submitted: | September 30, 2020 |
Results First Posted: | October 30, 2020 |
Last Update Posted: | October 30, 2020 |