Cardiovascular DiseasePhase 1NCT03626662

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

A Phase 1 study testing AMG 890 in people with Cardiovascular Disease, run by Amgen at 9 sites in 2 countries.

Completed

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

Trial summary

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease
What is being tested?: AMG 890
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 9 sitesin 2 countries
Study dates: 30 Jul 2018to 18 Apr 2023
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women with ages between 18 and 70 years old, inclusive.
Protocol-defined elevated plasma Lp(a) level.
Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
Women must be of non-reproductive potential.
Other Inclusion criteria may apply

Who cannot join

Currently receiving treatment in another investigational device or drug study.
Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
History or clinical evidence of bleeding diathesis or any coagulation disorder.
History or clinical evidence of peripheral neuropathy.
Other Exclusion criteria may apply

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

United States7 sites

Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Medpace Inc
Cincinnati, Ohio, 45227
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
University of Kansas Medical Center
Kansas City, Kansas, 66160
New York University
New York, New York, 10016
QPS Miami Research Associates
South Miami, Florida, 33143
Orange County Research Center
Tustin, California, 92780

Other trials in United States

Australia2 sites

Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, 5000
Linear Clinical Research Limited
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

Conditions: Cardiovascular Disease
Being tested: AMG 890, Placebo
Medical subject headings: Cardiovascular Diseases

What participants receive

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

AMG 890Drug
Ascending Single Doses of AMG 890
PlaceboDrug
Calculated volume to match experimental drug.

Study groups in NCT03626662
Study group	Role	What they receive
Placebo	Placebo comparator	Single Ascending Dose Cohorts Receives: Drug: Placebo
AMG 890	Experimental	Single Ascending Dose Cohorts Receives: Drug: AMG 890

What is being measured

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

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
Measured: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months

Secondary outcomes (5)

Maximum Observed Concentration (Cmax) of Olpasiran
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Measured: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Time to Reach Cmax (Tmax) of Olpasiran
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Measured: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Measured: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Change From Baseline in Plasma Lp(a) Levels
Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented.
Measured: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented.
Measured: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365

Timeline

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

30 Jul 201818 Apr 2023

First posted13 Aug 2018
Study start30 Jul 2018
Primary completion18 Apr 2023
Study completion18 Apr 2023

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03626662
Sponsor's protocol ID: 20170544
Status last verified: Dec 2025
First submitted: 19 Jun 2018
Last updated: 28 Jan 2026
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

Publications

Koren MJ, Moriarty PM, Baum SJ, Neutel J, Hernandez-Illas M, Weintraub HS, Florio M, Kassahun H, Melquist S, Varrieur T, Haldar SM, Sohn W, Wang H, Elliott-Davey M, Rock BM, Pei T, Homann O, Hellawell J, Watts GF. Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a). Nat Med. 2022 Jan;28(1):96-103. doi: 10.1038/s41591-021-01634-w. Epub 2022 Jan 13.
PubMed 35027752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
ClinicalTrials.gov ID: NCT03626662
Acronym / sponsor ID: 20170544
Conditions: Cardiovascular Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 30 Jul 2018 (actual)
Primary completion: 18 Apr 2023 (actual)
Study completion: 18 Apr 2023 (actual)
First posted: 13 Aug 2018 (actual)
Results: Posted 28 Jan 2026

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSingle Ascending Dose Cohorts
AMG 890	Experimental	Drug: AMG 890Single Ascending Dose Cohorts

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Men and women with ages between 18 and 70 years old, inclusive.
Protocol-defined elevated plasma Lp(a) level.
Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
Women must be of non-reproductive potential.
Other Inclusion criteria may apply

Key exclusion criteria (6 listed)

Currently receiving treatment in another investigational device or drug study.
Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
History or clinical evidence of bleeding diathesis or any coagulation disorder.
History or clinical evidence of peripheral neuropathy.

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
AMG 890Ascending Single Doses of AMG 890	Drug	AMG 890
PlaceboCalculated volume to match experimental drug.	Drug	Placebo

Primary outcome

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.

5 secondary outcomes

Maximum Observed Concentration (Cmax) of Olpasiran
Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Time to Reach Cmax (Tmax) of Olpasiran
Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran
Time frame: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dose
Change From Baseline in Plasma Lp(a) Levels
Time frame: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365
Percent Change From Baseline in Plasma Lp(a) Levels
Time frame: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365

Results and safety

Results posted to the registry on 28 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	17
Cohort 1: Olpasiran 3 mg	6	6
Cohort 2: Olpasiran 9 mg	6	4
Cohort 3: Olpasiran 30 mg	6	6
Cohort 4 Olpasiran: 75 mg	6	2
Cohort 5 Olpasiran: 225 mg	6	3
Cohort 6: Olpasiran 9 mg	9	8
Cohort 7: Olpasiran 75 mg	9	6
Cohort 8: Olpasiran 225 mg	5	5
Cohort 9: Olpasiran 675 mg	6	5

Primary outcome: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months. Count of participants. Unit: Participants

Measure	Cohorts 1-5: Placebo n = 10	Cohort 1: Olpasiran 3 mg n = 6	Cohort 2: Olpasiran 9 mg n = 6	Cohort 3: Olpasiran 30 mg n = 6	Cohort 4 Olpasiran: 75 mg n = 6	Cohort 5 Olpasiran: 225 mg n = 6	Cohorts 6-9: Placebo n = 10	Cohort 6: Olpasiran 9 mg n = 9	Cohort 7: Olpasiran 75 mg n = 9	Cohort 8: Olpasiran 225 mg n = 5	Cohort 9: Olpasiran 675 mg n = 6
Value	5	3	3	5	1	0	7	6	3	4	4

Population analysed: The safety analysis set consisted of all participants who received at least 1 dose of Olpasiran or placebo.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohorts 1-5: Placebo	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Cohorts 6-9: Placebo	1 of 10 (10%)	7 of 10 (70%)	0 of 10
Cohort 1: Olpasiran 3 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 2: Olpasiran 9 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 3: Olpasiran 30 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 4 Olpasiran: 75 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cohort 5 Olpasiran: 225 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 6: Olpasiran 9 mg	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Cohort 7: Olpasiran 75 mg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 8: Olpasiran 225 mg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort 9: Olpasiran 675 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35027752Koren MJ, Moriarty PM, Baum SJ, Neutel J, Hernandez-Illas M, Weintraub HS, Florio M, Kassahun H, Melquist S, Varrieur T, Haldar SM, Sohn W, Wang H, Elliott-Davey M, Rock BM, Pei T, Homann O, Hellawell J, Watts GF. Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a). Nat Med. 2022 Jan;28(1):96-103. doi: 10.1038/s41591-021-01634-w. Epub 2022 Jan 13.
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

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 890 in people with Cardiovascular Disease, run by Amgen at 9 sites in 2 countries.

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 5 inclusion and 6 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Australia. 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. Some participants in this study may receive a placebo. 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 28 Jan 2026). 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?

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months). 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 NCT03626662, which also lists 1 linked publication.

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 28 Jan 2026.