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

• ClinicalTrials.gov Identifier: NCT04270760
• Recruitment Status: Active, not recruiting
• First Posted: February 17, 2020
• Last Update Posted: June 15, 2021
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 290 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
• Estimated Primary Completion Date: January 3, 2022
• Estimated Study Completion Date: March 30, 2023

Arms and Interventions

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

Primary Outcome Measures :

1. Percent change in Lp(a) [ Time Frame: Baseline and week 36 ]

Secondary Outcome Measures :

1. Percentage change from baseline in Lp(a) [ Time Frame: Baseline and week 48 ]
2. Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Weeks 36 and 48 ]
3. Percentage change in Apolipoprotein(B) (ApoB) [ Time Frame: Baseline and weeks 36 and 48 ]
4. Maximum observed concentration (Cmax) of Olpasiran [ Time Frame: 48 weeks ]
5. Area under the concentration-time curve (AUC) of Olpasiran [ Time Frame: 48 weeks ]

Eligibility Criteria

• 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

Locations

United States, California

Research Site

Beverly Hills, California, United States, 90211

United States, Florida

Research Site

Boca Raton, Florida, United States, 33434

United States, Georgia

Research Site

Atlanta, Georgia, United States, 30309

United States, Kansas

Research Site

Kansas City, Kansas, United States, 66160

United States, Maryland

Research Site

Baltimore, Maryland, United States, 21287

United States, New York

Research Site

New York, New York, United States, 10016

Research Site

New York, New York, United States, 10029

Research Site

New York, New York, United States, 10032

United States, North Carolina

Research Site

Mooresville, North Carolina, United States, 28117

United States, Ohio

Research Site

Cleveland, Ohio, United States, 44195

United States, Texas

Research Site

Houston, Texas, United States, 77030

Research Site

Hurst, Texas, United States, 76054

Australia, New South Wales

Research Site

Camperdown, New South Wales, Australia, 2050

Australia, Queensland

Research Site

Milton, Queensland, Australia, 4064

Australia, Victoria

Research Site

Clayton, Victoria, Australia, 3168

Australia, Western Australia

Research Site

Nedlands, Western Australia, Australia, 6009

Australia

Research Site

Woolloongabba, Australia, 4102

Canada, Ontario

Research Site

Brampton, Ontario, Canada, L6S 0C6

Research Site

Concord, Ontario, Canada, L4K 4M2

Canada, Quebec

Research Site

Chicoutimi, Quebec, Canada, G7H 7K9

Research Site

Montreal, Quebec, Canada, H4A 3J1

Canada

Research Site

Quebec, Canada, G1V 4W2

Denmark

Research Site

Aarhus N, Denmark, 8200

Research Site

Herlev, Denmark, 2730

Research Site

Viborg, Denmark, 8800

Iceland

Research Site

Kopavogur, Iceland, 201

Japan

Research Site

Asahi-shi, Chiba, Japan, 289-2511

Research Site

Kashiwa-shi, Chiba, Japan, 277-8567

Research Site

Asahikawa-shi, Hokkaido, Japan, 070-8610

Research Site

Kahoku-gun, Ishikawa, Japan, 920-0293

Research Site

Iruma-gun, Saitama, Japan, 350-0495

Netherlands

Research Site

Amsterdam, Netherlands, 1105 AZ

Research Site

Arnhem, Netherlands, 6815 AD

Research Site

The Hague, Netherlands, 2545 AA

Research Site

Utrecht, Netherlands, 3584 CX

Research Site

Venlo, Netherlands, 5912 BL

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT04270760
• Other Study ID Numbers: 20180109; 2019-003688-23 ( EudraCT Number )
• First Posted: February 17, 2020
• Last Update Posted: June 15, 2021
• Last Verified: June 2021

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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:

AMG 890; Olpasiran; siRNA; lipoprotein (a) Lp(a); Cardiovascular; Cardiovascular disease; Atherosclerotic cardiovascular disease; Cholesterol; Apolipoprotein (B); Hyperlipidemia; Dyslipidemia

Additional relevant MeSH terms:

Cardiovascular Diseases