Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
- Registration Number
- NCT04270760
- Lead Sponsor
- Amgen
- Brief Summary
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp\[a\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
- Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Olpasiran Dose 1 Olpasiran - Arm 2 Olpasiran Dose 2 Olpasiran - Arm 4 Olpasiran Dose 4 Olpasiran - Arm 5 Placebo Dose 5 Placebo - Arm 3 Olpasiran Dose 3 Olpasiran -
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 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
Name Time Method Percentage Change From Baseline in Lp(a) at Week 48 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.
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48 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.
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48 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.
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48 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.
Trial Locations
- Locations (36)
VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Regionshospitalet Viborg
🇩🇰Viborg, Denmark
Haga Ziekenhuis
🇳🇱The Hague, Netherlands
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
New York University
🇺🇸New York, New York, United States
Clinique des Maladies Lipidiques de Quebec Incorporated
🇨🇦Quebec, Canada
Core Research Group Pty Ltd
🇦🇺Milton, Queensland, Australia
Crossroads Clinical Research Inc
🇺🇸Mooresville, North Carolina, United States
Linear Clinical Research Limited
🇦🇺Nedlands, Western Australia, Australia
The Jikei University Kashiwa Hospital
🇯🇵Kashiwa-shi, Chiba, Japan
Thjonustumidstod Rannsoknaverkefna
🇮🇸Kopavogur, Iceland
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Dr Heart Pty Ltd
🇦🇺Woolloongabba, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
LMC Clinical Research Incorporated
🇨🇦Brampton, Ontario, Canada
LMC Clinical Research Incorporated Thornhill
🇨🇦Concord, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Research Institute of McGill University Health Center - Glen Site
🇨🇦Montreal, Quebec, Canada
Herlev Gentofte Hospital
🇩🇰Herlev, Denmark
Asahikawa City Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
Saitama Medical University Hospital
🇯🇵Iruma-gun, Saitama, Japan
Kanazawa Medical University Hospital
🇯🇵Kahoku-gun, Ishikawa, Japan
Asahi General Hospital
🇯🇵Asahi-shi, Chiba, Japan
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States