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NCT04270760 Clinical Trial

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

Cardiovascular Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04270760
Other study ID # 20180109
Secondary ID 2019-003688-23
Status Completed
Phase Phase 2
First received
Last updated
Start date July 28, 2020
Est. completion date November 8, 2022

Study information
Verified date August 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 281
Est. completion date November 8, 2022
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
• Placebo
Dose 5

Locations
Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Monash Medical Centre Clayton Victoria
Australia Core Research Group Pty Ltd Milton Queensland
Australia Linear Clinical Research Limited Nedlands Western Australia
Australia Dr Heart Pty Ltd Woolloongabba
Canada LMC Clinical Research Incorporated Brampton Ontario
Canada Ecogene-21 Chicoutimi Quebec
Canada LMC Clinical Research Incorporated Thornhill Concord Ontario
Canada Research Institute of McGill University Health Center - Glen Site Montreal Quebec
Canada Clinique des Maladies Lipidiques de Quebec Incorporated Quebec
Denmark Aarhus Universitetshospital Aarhus N
Denmark Herlev Gentofte Hospital Herlev
Denmark Regionshospitalet Viborg Viborg
Iceland Thjonustumidstod Rannsoknaverkefna Kopavogur
Japan Asahi General Hospital Asahi-shi Chiba
Japan Asahikawa City Hospital Asahikawa-shi Hokkaido
Japan Saitama Medical University Hospital Iruma-gun Saitama
Japan Kanazawa Medical University Hospital Kahoku-gun Ishikawa
Japan The Jikei University Kashiwa Hospital Kashiwa-shi Chiba
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Rijnstate Ziekenhuis Arnhem
Netherlands Haga Ziekenhuis The Hague
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Netherlands VieCuri Medisch Centrum Venlo
United States Piedmont Healthcare Atlanta Georgia
United States Johns Hopkins Baltimore Maryland
United States Westside Medical Associates of Los Angeles Beverly Hills California
United States Excel Medical Clinical Trials Boca Raton Florida
United States Cleveland Clinic Cleveland Ohio
United States Baylor College of Medicine Houston Texas
United States Protenium Clinical Research Hurst Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Crossroads Clinical Research Inc Mooresville North Carolina
United States Columbia University Medical Center New York New York
United States Mount Sinai Hospital New York New York
United States New York University New York New York

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Iceland,  Japan,  Netherlands, 

References & Publications (2)

O'Donoghue ML, G Lopez JA, Knusel B, Gencer B, Wang H, Wu Y, Kassahun H, Sabatine MS. Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE). Am Heart J. 2022 Sep;251:61-69. doi: 10.1016/j.ahj.2022.05.004. Epub 2022 May 16. — View Citation

O'Donoghue ML, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Ran X, Murphy SA, Wang H, Wu Y, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864. doi: 10.1056/NEJMoa2211023. Epub 2022 Nov 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at 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 Percentage Change From Baseline in Lp(a) at 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
Secondary Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at 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
Secondary Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at 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
Secondary Mean Serum Olpasiran Concentrations at Day 1, Week 24 and 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
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