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

NCT05481411 | Completed Phase 1 FDA Drug

• 1 other identifier: 20220009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.

Conditions

Hepatic Impairment

Keywords

Olpasiran; Hepatic Impairment; Normal Hepatic Function; AMG 890

Outcome Measures

Primary Outcomes (3)

• 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

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 Hepatic Impairment

EXPERIMENTAL

Participants will be enrolled in 1 of 3 hepatic impairment groups based on their hepatic impairment status, as determined by Child-Pugh classification. All participants will receive a single dose of olpasiran on Day 1.

Drug: Olpasiran

Single Dose Olpasiran Normal Hepatic Function

EXPERIMENTAL

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

Drug: Olpasiran

Interventions

Olpasiran DRUG

Subcutaneous injection

Also known as: AMG 890

Single Dose Olpasiran Hepatic Impairment; Single Dose Olpasiran Normal Hepatic Function

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 or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening.
• Body mass index between 18.0 and 40.0 kg/m\^2 (inclusive) at the time of Screening.
• Participants with Normal Hepatic Function Only:
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee).
• Participants with Hepatic Impairment Only:
• Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings.

You may not qualify if:

• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 (Groups 1-3) or \< 50 mL/min/1.73m\^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in.
• Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran.
• Participants who were previously exposed to olpasiran.
• Female participants with a positive pregnancy test at Screening or Check-in.
• Participants with Normal Hepatic Function Only:
• Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included.
• Alanine aminotransferase and aspartate aminotransferase elevations \> 3x upper limit of normal at Screening or Check-in.
• Participants with Hepatic Impairment Only:
• Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination).
• Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed.
• Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute, Inc.

San Antonio, Texas, 78215, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

olpasiran

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: July 28, 2022
• First Posted: August 1, 2022
• Study Start: September 13, 2022
• Primary Completion: April 5, 2023
• Study Completion: May 31, 2023
• Last Updated: October 15, 2025

Record last verified: 2025-10

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 (3)