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Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270760
Recruitment Status : Completed
First Posted : February 17, 2020
Results First Posted : August 23, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Olpasiran Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
Actual Study Start Date : July 28, 2020
Actual Primary Completion Date : December 27, 2021
Actual Study Completion Date : November 8, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1 Olpasiran Dose 1 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 2 Olpasiran Dose 2 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 3 Olpasiran Dose 3 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Active Comparator: Arm 4 Olpasiran Dose 4 Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890
Placebo Comparator: Arm 5 Placebo Dose 5 Drug: Placebo
Dose 5


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 [ Time Frame: Baseline and Week 36 ]
    Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.


Secondary Outcome Measures :
  1. Percentage Change From Baseline in Lp(a) at Week 48 [ Time Frame: Baseline and Week 48 ]
    Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.

  2. Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ]
    Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.

  3. Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ]
    Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.

  4. Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48 [ Time Frame: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48 ]

    Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.

    Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years
  • Lipoprotein (a) > 150 nmol/L
  • Evidence of atherosclerotic cardiovascular disease

Exclusion Criteria:

  • Severe renal dysfunction
  • History or clinical evidence of hepatic dysfunction
  • Malignancy within the last 5 years
  • Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270760


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] May 2, 2022
Statistical Analysis Plan  [PDF] May 10, 2022

More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04270760    
Other Study ID Numbers: 20180109
2019-003688-23 ( EudraCT Number )
First Posted: February 17, 2020    Key Record Dates
Results First Posted: August 23, 2023
Last Update Posted: September 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Olpasiran
AMG 890
siRNA
lipoprotein (a) Lp(a)
Cardiovascular
Cardiovascular disease
 Atherosclerotic cardiovascular disease
Cholesterol
Apolipoprotein (B)
Hyperlipidemia
Dyslipidemia
Additional relevant MeSH terms:
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Cardiovascular Diseases