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Completed

NCT Number: NCT04270760

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

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

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olpasiran

Drug

Dose 1 Dose 2 Dose 3 Dose 4

Other names: AMG 890

Placebo

Drug

Dose 5

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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