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

August 24, 2023 updated by: Amgen

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Woolloongabba, Australia, 4102
        • Dr Heart Pty Ltd
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Core Research Group Pty Ltd
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Limited
  • Canada
      • Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Incorporated
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • LMC Clinical Research Incorporated
      • Concord, Ontario, Canada, L4K 4M2
        • LMC Clinical Research Incorporated Thornhill
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute of McGill University Health Center - Glen Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • Herlev, Denmark, 2730
        • Herlev Gentofte Hospital
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg
  • Iceland
      • Kopavogur, Iceland, 201
        • Thjonustumidstod Rannsoknaverkefna
  • Japan
    • Chiba
      • Asahi-shi, Chiba, Japan, 289-2511
        • Asahi General Hospital
      • Kashiwa-shi, Chiba, Japan, 277-8567
        • The Jikei University Kashiwa Hospital
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
    • Ishikawa
      • Kahoku-gun, Ishikawa, Japan, 920-0293
        • Kanazawa Medical University Hospital
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Saitama Medical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate Ziekenhuis
      • The Hague, Netherlands, 2545 AA
        • Haga ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Westside Medical Associates of Los Angeles
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Healthcare
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • New York University
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Mooresville, North Carolina, United States, 28117
        • Crossroads Clinical Research Inc
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 Olpasiran Dose 1
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Names:
  • AMG 890
Active Comparator: Arm 2 Olpasiran Dose 2
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Names:
  • AMG 890
Active Comparator: Arm 3 Olpasiran Dose 3
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Names:
  • AMG 890
Active Comparator: Arm 4 Olpasiran Dose 4
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Names:
  • AMG 890
Placebo Comparator: Arm 5 Placebo Dose 5
Drug: Placebo
Dose 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 48
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.
Baseline; Week 36 and Week 48
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.
Baseline; Week 36 and Week 48
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.
Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2020

Primary Completion (Actual)

December 27, 2021

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180109
  • 2019-003688-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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