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Completed

NCT Number: NCT05489614

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment

The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inland Empire Clinical Trials, LLC, Rialto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Male participants or female participants of nonchildbearing potential between 18 and 75 years of age (inclusive) at the time of Screening.
  • Body mass index between 18 and 40 kg/m^2 (inclusive) at the time of Screening.
  • Eligible participants classified based on established need for renal replacement therapy and eGFR at Screening. Assignment will be based on eGFR at Screening.
  • Group 1 (Normal): eGFR ≥ 90 mL/min and no history of renal disease.
  • Group 2 (Mild): 60 ≤ eGFR ≤ 89 mL/min.
  • Group 3 (Moderate): 30 ≤ eGFR ≤ 59 mL/min.
  • Group 4 (Severe): 15 ≤ eGFR ≤ 29 mL/min without dialysis.
  • Group 5 (Kidney Failure): eGFR < 15 mL/min and dialysis patients (off-dialysis).
  • Group 6 (Kidney Failure): eGFR < 15 mL/min and dialysis patients (on-dialysis).

Exclusion:

  • Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal.
  • Clinically significant hyperkalemia (defined by serum potassium concentration as > 5.5 mEq/L for Groups 1 to 4, > 6 mEq/L for Groups 5 and 6) at Screening or Check-in.
  • History of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
  • Female participants with a positive pregnancy test at Screening or Check-in.
  • Participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to Check-in.

Participants in Group 1 only (participants with normal renal function) are excluded if:

  • A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at Screening or Check-in.

Participants in Groups 2 to 6 (participants with varying degrees of renal impairment) are excluded if:

  • A change in disease status within 30 days of Screening, as documented by the participant's medical history, deemed clinically significant by the Investigator.

Treatment and study plan

Olpasiran

Drug

Participants will receive olpasiran by subcutaneous (SC) injection.

Other names: AMG 890

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of Olpasiran

    Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

  2. Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran

    Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

  3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran

    Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

  4. Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran

    Time frame: Pre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4

Secondary outcomes

  1. Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])

    Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

  2. Maximum Inhibitory Effect (Imax) of Plasma Lp(a)

    Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

  3. Time to Reach Imax of Lp(a)

    Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85

  4. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to Day 85

  5. Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations

    Time frame: Up to Day 85

  6. Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements

    Time frame: Up to Day 85

  7. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: Up to Day 85

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Subjects With Normal Renal Function and Subjects With Various Degrees of Renal Impairment

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2022
Registry last updated
Nov 26, 2025

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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