Elevated Serum Lipoprotein(a)Phase 1NCT04987320

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)

A Phase 1 study testing Olpasiran in people with Elevated Serum Lipoprotein(a), run by Amgen at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Elevated Serum Lipoprotein(a)
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: 24 participants
Where: 1 siteHong Kong
Study dates: 28 Jul 2021to 18 Mar 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Inclusion eligibility criteria will be evaluated in 2 parts during the screening period:
Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.
Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.
Part 1:
Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry.
Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening.

Show all 13Show fewer

Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).
Part 2:
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).
Body mass index between 18 and 32 kg/m^2 (inclusive) at the time of Screening.
Subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose (i.e., no change in medication or dosage) for the duration of the study.
Females must be of non-reproductive potential:
Postmenopausal defined as: i. Age of ≥ 55 years with no menses for at least 12 months; OR ii. Age of < 55 years with no menses for at least 12 months AND with a follicle stimulating hormone (FSH) level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR b. History of hysterectomy; OR c. History of bilateral oophorectomy.

Who cannot join

History or clinical evidence of peripheral neuropathy.
Currently receiving apheresis as lipid reducing therapy.
History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory's normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory's normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.
History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening.
Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils > 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Queen Mary Hospital
Hong Kong, HK

Other trials in Hong Kong

About this study

Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Subjects With Elevated Serum Lipoprotein(a)

The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]).

Conditions: Elevated Serum Lipoprotein(a)
Being tested: Olpasiran
Keywords: Elevated serum lipoprotein(a), Olpasiran

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlpasiranDrug
Also called AMG 890
Subcutaneous injection

Study groups in NCT04987320
Study group	Role	What they receive
Olpasiran Dose A	Experimental	Participants will be administered Olpasiran dose A as a subcutaneous injection. Receives: Drug: Olpasiran
Olpasiran Dose B	Experimental	Participants will be administered Olpasiran dose B as a subcutaneous injection. Receives: Drug: Olpasiran

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration (Cmax) of Olpasiran
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

Secondary outcomes (15)

Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Time to Cmax (Tmax) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Terminal Elimination Half-life (T1/2) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Total Body Clearance (CL/F) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Measured: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as an AE that starts on or after the first dose of investigational product and up to end of study.
Clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms, and vital signs were reported as AEs.
Measured: Up to Day 225
Percentage Change From Baseline in Triglycerides
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Total Cholesterol
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Measured: Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202118 Mar 2022

First posted3 Aug 2021
Study start28 Jul 2021
Primary completion12 Nov 2021
Study completion18 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Elevated Serum Lipoprotein(a)Studies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04987320
Sponsor's protocol ID: 20190095
Status last verified: Jan 2025
First submitted: 26 Jul 2021
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Subjects With Elevated Serum Lipoprotein(a)
ClinicalTrials.gov ID: NCT04987320
Acronym / sponsor ID: 20190095
Conditions: Elevated Serum Lipoprotein(a)
Keywords: Elevated serum lipoprotein(a), Olpasiran
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 28 Jul 2021 (actual)
Primary completion: 12 Nov 2021 (actual)
Study completion: 18 Mar 2022 (actual)
First posted: 3 Aug 2021 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp[a]).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Olpasiran Dose A	Experimental	Drug: OlpasiranParticipants will be administered Olpasiran dose A as a subcutaneous injection.
Olpasiran Dose B	Experimental	Drug: OlpasiranParticipants will be administered Olpasiran dose B as a subcutaneous injection.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.
Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.
Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry.
Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening.
Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).

Key exclusion criteria (5 listed)

History or clinical evidence of peripheral neuropathy.
Currently receiving apheresis as lipid reducing therapy.
History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory's normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory's normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.
History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening.
Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils > 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study.

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 890Subcutaneous injection	Drug	Olpasiran Dose A, Olpasiran Dose B

Primary outcome

Maximum Observed Concentration (Cmax) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.

15 secondary outcomes

Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Time to Cmax (Tmax) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Terminal Elimination Half-life (T1/2) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Total Body Clearance (CL/F) of Olpasiran
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 225
Percentage Change From Baseline in Triglycerides
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Total Cholesterol
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Time frame: Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olpasiran Low Dose	12	12
Olpasiran High Dose	12	11

Primary outcome: Maximum Observed Concentration (Cmax) of Olpasiran

Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Olpasiran Low Dose n = 12	Olpasiran High Dose n = 12
Value	144 (55.5)	549 (71.5)

Population analysed: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 225 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olpasiran Low Dose	1 of 12 (8.3%)	11 of 12 (91.7%)	0 of 12
Olpasiran High Dose	1 of 12 (8.3%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

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

1 site 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 Elevated Serum Lipoprotein(a), run by Amgen at 1 site in Hong Kong.

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 13 inclusion and 5 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Concentration (Cmax) of Olpasiran (time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04987320.

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 10 Feb 2025.