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

NCT05489614 | Completed Phase 1 FDA Drug

• 1 other identifier: 20220010
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Renal Impairment

Keywords

Olpasiran; Renal Impairment; Normal Renal Function; AMG 890

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Serum Concentration (Cmax) of Olpasiran

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

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

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

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

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

• Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran

  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 (7)

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

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

• Maximum Inhibitory Effect (Imax) of Plasma Lp(a)

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

• Time to Reach Imax of Lp(a)

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

• Number of Participants Who Experience an Adverse Event (AE)

  Up to Day 85

• Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations

  Up to Day 85

Study Arms (2)

Single Dose Olpasiran Renal Impairment

EXPERIMENTAL

Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1.

Drug: Olpasiran

Single Dose Olpasiran Normal Renal Function

EXPERIMENTAL

Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.

Drug: Olpasiran

Interventions

Olpasiran DRUG

Participants will receive olpasiran by subcutaneous (SC) injection.

Also known as: AMG 890

Single Dose Olpasiran Normal Renal Function; Single Dose Olpasiran Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (6)

Inland Empire Clinical Trials, LLC

Rialto, California, 92377-4697, United States

Location

CRSCA HC LLC, dba Creekside Post Acute

Yucaipa, California, 92399, United States

Location

Clinical Pharmacology Of Miami, LLC

Miami, Florida, 33014, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147-4040, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Nucleus Network - Minneapolis

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency

Interventions

olpasiran

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: September 13, 2022
• Primary Completion: October 24, 2023
• Study Completion: December 19, 2023
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (6)