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Completed

NCT Number: NCT03626662

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Medical and Analytical eXellence CMAX, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women with ages between 18 and 70 years old, inclusive.
  • Protocol-defined elevated plasma Lp(a) level.
  • Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
  • Women must be of non-reproductive potential.
  • Other Inclusion criteria may apply

Exclusion criteria

  • Currently receiving treatment in another investigational device or drug study.
  • Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
  • History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • History or clinical evidence of bleeding diathesis or any coagulation disorder.
  • History or clinical evidence of peripheral neuropathy.
  • Other Exclusion criteria may apply

Treatment and study plan

AMG 890

Drug

Ascending Single Doses of AMG 890

Placebo

Drug

Calculated volume to match experimental drug.

Primary outcomes

  1. Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

    Time frame: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months

    An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of Olpasiran

    Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose

    Blood samples were collected for measurement of serum concentrations of Olpasiran.

  2. Time to Reach Cmax (Tmax) of Olpasiran

    Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose

    Blood samples were collected for measurement of serum concentrations of Olpasiran.

  3. Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran

    Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose

    Blood samples were collected for measurement of serum concentrations of Olpasiran.

  4. Change From Baseline in Plasma Lp(a) Levels

    Time frame: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365

    Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented.

  5. Percent Change From Baseline in Plasma Lp(a) Levels

    Time frame: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365

    Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2018
Registry last updated
Jan 28, 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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