Renal ImpairmentPhase 1NCT05489614
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 1 study testing Olpasiran in people with Renal Impairment, run by Amgen at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Olpasiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Sep 2022to 19 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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:
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Clinical Pharmacology Of Miami, LLC
Miami, Florida, 33014
Advanced Pharma CR, LLC
Miami, Florida, 33147-4040
Orlando Clinical Research Center
Orlando, Florida, 32809
Inland Empire Clinical Trials, LLC
Rialto, California, 92377-4697
Nucleus Network - Minneapolis
Saint Paul, Minnesota, 55114
CRSCA HC LLC, dba Creekside Post Acute
Yucaipa, California, 92399
About this study
Official 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
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
- Being tested
- Olpasiran
- Keywords
- Olpasiran, Renal Impairment, Normal Renal Function, AMG 890
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlpasiranDrug
Also called AMG 890
Participants will receive olpasiran by subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Olpasiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of Olpasiran
Measured: 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
Measured: 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
Measured: 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
Measured: 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])
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start13 Sep 2022
- Primary completion24 Oct 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489614
- Sponsor's protocol ID
- 20220010
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05489614
- Acronym / sponsor ID
- 20220010
- Conditions
- Renal Impairment
- Keywords
- Olpasiran, Renal Impairment, Normal Renal Function, AMG 890
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose Olpasiran Renal Impairment | Experimental | Drug: OlpasiranParticipants 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. |
| Single Dose Olpasiran Normal Renal Function | Experimental | Drug: OlpasiranParticipants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlpasiranAlso: AMG 890Participants will receive olpasiran by subcutaneous (SC) injection. | Drug | Single Dose Olpasiran Normal Renal Function, Single Dose Olpasiran Renal Impairment |
Primary outcome
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
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
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
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
7 secondary outcomes
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
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
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
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olpasiran in people with Renal Impairment, run by Amgen at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.