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
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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

External Links

•   AmgenTrials clinical trials website