Elevated Lipoprotein(a)Phase 2NCT02160899

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)

A Phase 2 study testing ISIS-APO(a)Rx in people with Elevated Lipoprotein(a), run by Ionis Pharmaceuticals, Inc. at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Elevated Lipoprotein(a)
What is being tested?: ISIS-APO(a)Rx
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 13 sitesin 5 countries
Study dates: Jun 2014to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged 18-65 inclusive
Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (defined as 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory involved)
Males must be surgically sterile, abstinent or if engaged in sexual relations with a female of child-bearing potential, the participant must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 16 weeks after the last dose of Study Drug
Body mass index (BMI) ≤40 kg/m2
Lipoprotein(a) ≥50 and <175 mg/dL at time of screening (Cohort A)
Lipoprotein(a) ≥175 mg/dL at time of screening (Cohort B)

Who cannot join

Clinically significant abnormalities in medical history (e.g., documented previous myocardial infarction, percutaneous coronary intervention (PCI), or major surgery within 3 months of screening, planned surgery that would occur during the study) or physical examination at screening
Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion
Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
Known history or positive test for human immunodeficiency virus (HIV), hepatitis C, or chronic hepatitis B
Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
History of bleeding diathesis or coagulopathy

Show all 13Show fewer

Recent history of, or current drug or alcohol abuse
Participant with Lp(a) ≥50 and <175 mg/dL may not receive concomitant niacin therapy during the period 8 weeks prior to screening through the end of the Post-Treatment Evaluation Period
Use of statins, ezetimibe or fibrates unless on a stable regimen for at least 8 weeks prior to dosing and will remain on a stable regimen for the duration of the study
Use of lipid or Lp(a)-specific apheresis within 4 weeks prior to Screening through the end of the Post-Treatment Evaluation Period
Use of concomitant drugs (including herbal or over-the-counter (OTC) medications other than ibuprofen, Benadryl or topical steroids) unless authorized by the Sponsor Medical Monitor
Blood donation of 50-499 mL within 30 days of screening or of >499 mL within 8 weeks of screening
Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study

Trial locations and contacts

13 sites in 5 countries.

Country

City, postcode or hospital

13 sites in 5 countries

Netherlands4 sites

University of Amsterdam - Dept. of Vascular Medicine F4-109
Amsterdam, 1105 AZ
Academic Hospital Maastricht
Maastricht, 6229 HX
Sint Franciscus Gasthuis
Rotterdam, 3045 PM
University Medical Center Utrecht
Utrecht, 3584 CX

Other trials in Netherlands

Germany3 sites

Charite - University Hospital Berlin - Campus Virchow - Hospital
Berlin, 13353
Uniklinik Koeln, Zentrum fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
Cologne, 50937
Otto-von Guericke Universitaet, Uniklinik Magdeburg
Magdeburg, 39120

Other trials in Germany

United Kingdom3 sites

Heart of England NHS Foundation Trust
Birmingham, B9 5SS
Barlow Medical Centre
Manchester, M20 2RN
Newcastle Upon Tyne Hospitals
Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Canada2 sites

Chicoutimi Hospital
Chicoutimi, Quebec, G7H 5H6
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, G1V4M6

Other trials in Canada

Denmark1 site

Herlev University Hospital
Herlev, 2730

Other trials in Denmark

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients With High Lipoprotein(a)

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.

Read the detailed description

Lipoprotein(a) [Lp(a)] is a genetic variant of low-density lipoprotein (LDL) in which the apolipoprotein B (apoB) -100 component of LDL is linked by a disulfide bond to apolipoprotein(a) [apo(a)], the distinct protein component of Lp(a) that is mainly responsible for its signature structural and functional properties. Lp(a) is now recognized as an important genetic risk factor for coronary artery disease, stroke and aortic stenosis.

The purpose of this study is to determine if ISIS-APO(a)Rx can reduce the production of apolipoprotein(a), or apo(a). This study will enroll 50 participants with Lipoprotein(a) ≥50 and <175 mg/dL and 10 participants with Lipoprotein(a) ≥175 mg/dL.

Conditions: Elevated Lipoprotein(a)
Being tested: ISIS-APO(a)Rx, Placebo
Keywords: High Lipoprotein(a)

What participants receive

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

ISIS-APO(a)RxDrug
Also called ISIS 494372
ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
PlaceboDrug
Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

Study groups in NCT02160899
Study group	Role	What they receive
Cohort A: Placebo	Placebo comparator	Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: Placebo
Cohort A: ISIS-APO(a)Rx < 2000 mg	Experimental	Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. Receives: Drug: ISIS-APO(a)Rx
Cohort A: ISIS-APO(a)Rx >= 2000 mg	Experimental	Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. Receives: Drug: ISIS-APO(a)Rx
Cohort B: Placebo	Placebo comparator	Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Receives: Drug: Placebo
Cohort B: ISIS-APO(a)Rx < 2000 mg	Experimental	Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. Receives: Drug: ISIS-APO(a)Rx
Cohort B: ISIS-APO(a)Rx >= 2000 mg	Experimental	Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. Receives: Drug: ISIS-APO(a)Rx

What is being measured

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

Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99
Data are reported for evaluable participants.
Measured: Day 85/Day 99
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
Measured: Up to approximately 32 weeks

Timeline

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

Jun 2014Nov 2015

First posted11 Jun 2014 (estimated)
Study startJun 2014
Primary completionNov 2015
Study completionNov 2015

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 (2)Papers the sponsor has linked to this study.
Other trials for Elevated Lipoprotein(a)Studies of the same condition, open and under way.
More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
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.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02160899
Sponsor's protocol ID: ISIS 494372-CS3
Status last verified: Dec 2019
First submitted: 5 Jun 2014
Last updated: 20 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Viney NJ, van Capelleveen JC, Geary RS, Xia S, Tami JA, Yu RZ, Marcovina SM, Hughes SG, Graham MJ, Crooke RM, Crooke ST, Witztum JL, Stroes ES, Tsimikas S. Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet. 2016 Nov 5;388(10057):2239-2253. doi: 10.1016/S0140-6736(16)31009-1. Epub 2016 Sep 21.
PubMed 27665230
Tragante V, Asselbergs FW, Swerdlow DI, Palmer TM, Moore JH, de Bakker PIW, Keating BJ, Holmes MV. Harnessing publicly available genetic data to prioritize lipid modifying therapeutic targets for prevention of coronary heart disease based on dysglycemic risk. Hum Genet. 2016 May;135(5):453-467. doi: 10.1007/s00439-016-1647-9. Epub 2016 Mar 5.
PubMed 26946290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
Atherosclerosis, Cardiovascular Diseases
Not yet recruitingPhase 1
A Study of Lepodisiran (LY3819469) in Participants With High Lipoprotein(a)
Lipoprotein(a)
RecruitingPhase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
Healthy Participants, Dyslipidemia
Active, not recruitingPhase 2
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
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Active, not recruitingPhase 3
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Atherosclerotic Cardiovascular Disease

All Elevated Lipoprotein(a) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients With High Lipoprotein(a)
ClinicalTrials.gov ID: NCT02160899
Acronym / sponsor ID: ISIS 494372-CS3
Conditions: Elevated Lipoprotein(a)
Keywords: High Lipoprotein(a)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 11 Jun 2014 (estimated)
Results: Posted 20 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort A: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
Cohort A: ISIS-APO(a)Rx < 2000 mg	Experimental	Drug: ISIS-APO(a)RxParticipants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
Cohort A: ISIS-APO(a)Rx >= 2000 mg	Experimental	Drug: ISIS-APO(a)RxParticipants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
Cohort B: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
Cohort B: ISIS-APO(a)Rx < 2000 mg	Experimental	Drug: ISIS-APO(a)RxParticipants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
Cohort B: ISIS-APO(a)Rx >= 2000 mg	Experimental	Drug: ISIS-APO(a)RxParticipants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males or females aged 18-65 inclusive
Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (defined as 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory involved)
Males must be surgically sterile, abstinent or if engaged in sexual relations with a female of child-bearing potential, the participant must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 16 weeks after the last dose of Study Drug
Body mass index (BMI) ≤40 kg/m2
Lipoprotein(a) ≥50 and <175 mg/dL at time of screening (Cohort A)

Key exclusion criteria (13 listed)

Clinically significant abnormalities in medical history (e.g., documented previous myocardial infarction, percutaneous coronary intervention (PCI), or major surgery within 3 months of screening, planned surgery that would occur during the study) or physical examination at screening
Clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion
Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
Known history or positive test for human immunodeficiency virus (HIV), hepatitis C, or chronic hepatitis B
Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ISIS-APO(a)RxAlso: ISIS 494372ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.	Drug	Cohort A: ISIS-APO(a)Rx < 2000 mg, Cohort A: ISIS-APO(a)Rx >= 2000 mg, Cohort B: ISIS-APO(a)Rx < 2000 mg, Cohort B: ISIS-APO(a)Rx >= 2000 mg
PlaceboNormal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.	Drug	Cohort A: Placebo, Cohort B: Placebo

Primary outcome

Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99
Time frame: Day 85/Day 99
Data are reported for evaluable participants.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 32 weeks
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.

Results and safety

Results posted to the registry on 20 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Placebo	26	26
Cohort A: ISIS-APO(a)Rx < 2000 mg	4	3
Cohort A: ISIS-APO(a)Rx >= 2000 mg	21	21
Cohort B: Placebo	3	2
Cohort B: ISIS-APO(a)Rx < 2000 mg	2	0
Cohort B: ISIS-APO(a)Rx >= 2000 mg	8	8

Primary outcome: Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99

Time frame: Day 85/Day 99. Mean (Standard Deviation). Unit: percent change

Measure	Cohort A: Placebo n = 26	Cohort A: ISIS-APO(a)Rx < 2000 mg n = 3	Cohort A: ISIS-APO(a)Rx >= 2000 mg n = 21	Cohort B: Placebo n = 2	Cohort B: ISIS-APO(a)Rx < 2000 mg n = 0	Cohort B: ISIS-APO(a)Rx >= 2000 mg n = 8
Value	-3.7 (13.7)	-44.5 (13.1)	-70.0 (19.6)	-5.6 (3.9)	–	-71.6 (13.0)

Cohort A: Placebo vs Cohort A: ISIS-APO(a)Rx < 2000 mg: p <.001, ANOVA
Cohort A: Placebo vs Cohort A: ISIS-APO(a)Rx >= 2000 mg: p <.001, ANOVA
Cohort B: Placebo vs Cohort B: ISIS-APO(a)Rx >= 2000 mg: p = 0.044, Exact Wilcoxon Rank Sum Test

Population analysed: The Per-Protocol Set included the subset of the Full Analysis Set who received at least 9 doses of Study Drug within the 12-week treatment period and who had no significant protocol deviations that would have been expected to affect efficacy assessments. Day 85/Day 99 result is defined as the result at Day 85 or Day 99.

Primary outcome: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

Time frame: Up to approximately 32 weeks. Count of participants. Unit: Participants

Measure	Cohort A: Placebo n = 26	Cohort A: ISIS-APO(a)Rx < 2000 mg n = 4	Cohort A: ISIS-APO(a)Rx >= 2000 mg n = 21	Cohort B: Placebo n = 3	Cohort B: ISIS-APO(a)Rx < 2000 mg n = 2	Cohort B: ISIS-APO(a)Rx >= 2000 mg n = 8
Value	23	4	21	2	2	8

Population analysed: The Safety Set included all randomized participants who received at least one dose of study drug.

Adverse events

Time frame: Up to approximately 32 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Placebo	0 of 26 (0%)	23 of 26 (88.5%)	0 of 26
Cohort A: ISIS-APO(a)Rx < 2000 mg	2 of 4 (50%)	3 of 4 (75%)	0 of 4
Cohort A: ISIS-APO(a)Rx >= 2000 mg	0 of 21 (0%)	21 of 21 (100%)	0 of 21
Cohort B: Placebo	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Cohort B: ISIS-APO(a)Rx < 2000 mg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Cohort B: ISIS-APO(a)Rx >= 2000 mg	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27665230Viney NJ, van Capelleveen JC, Geary RS, Xia S, Tami JA, Yu RZ, Marcovina SM, Hughes SG, Graham MJ, Crooke RM, Crooke ST, Witztum JL, Stroes ES, Tsimikas S. Antisense oligonucleotides targeting apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-blind, placebo-controlled, dose-ranging trials. Lancet. 2016 Nov 5;388(10057):2239-2253. doi: 10.1016/S0140-6736(16)31009-1. Epub 2016 Sep 21.
Derived from this study: PubMed 26946290Tragante V, Asselbergs FW, Swerdlow DI, Palmer TM, Moore JH, de Bakker PIW, Keating BJ, Holmes MV. Harnessing publicly available genetic data to prioritize lipid modifying therapeutic targets for prevention of coronary heart disease based on dysglycemic risk. Hum Genet. 2016 May;135(5):453-467. doi: 10.1007/s00439-016-1647-9. Epub 2016 Mar 5.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISIS-APO(a)Rx in people with Elevated Lipoprotein(a), run by Ionis Pharmaceuticals, Inc. at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands, Germany, United Kingdom, Canada, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99 (time frame: Day 85/Day 99). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160899, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.