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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05489614
Enrollment
33
Registered
2022-08-05
Start date
2022-09-13
Completion date
2023-12-19
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

Olpasiran, Renal Impairment, Normal Renal Function, AMG 890

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.

Interventions

Participants will receive olpasiran by subcutaneous (SC) injection.

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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. 1. Group 1 (Normal): eGFR ≥ 90 mL/min and no history of renal disease. 2. Group 2 (Mild): 60 ≤ eGFR ≤ 89 mL/min. 3. Group 3 (Moderate): 30 ≤ eGFR ≤ 59 mL/min. 4. Group 4 (Severe): 15 ≤ eGFR ≤ 29 mL/min without dialysis. 5. Group 5 (Kidney Failure): eGFR \< 15 mL/min and dialysis patients (off-dialysis). 6. 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.

Design outcomes

Primary

MeasureTime frame
Maximum Observed Serum Concentration (Cmax) of OlpasiranPredose, 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 OlpasiranPredose, 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 OlpasiranPredose, 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 OlpasiranPre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4

Secondary

MeasureTime frame
Number of Participants with Clinically Significant Changes in Clinical Laboratory EvaluationsUp to Day 85
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
Number of Participants with Clinically Significant Changes in Vital SignsUp to Day 85
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) MeasurementsUp to 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026