CompletedNCT03626662Updated Jan 28, 2026Results posted

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

A Phase 1 interventional study of AMG 890 and Placebo in Cardiovascular Disease, sponsored by Amgen. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Amgen · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 79
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Cardiovascular Disease

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Cardiovascular Diseases 4,904

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 79 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

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Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 79 participants (actual)

Study arms

Placebo comparator
Placebo
Single Ascending Dose Cohorts
Drug: Placebo
Experimental
AMG 890
Single Ascending Dose Cohorts
Drug: AMG 890

Interventions

DrugAMG 890
Ascending Single Doses of AMG 890
DrugPlacebo
Calculated volume to match experimental drug.

What researchers measure

Primary outcomes

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

Secondary outcomes

Maximum Observed Concentration (Cmax) of Olpasiran
Blood samples were collected for measurement of serum concentrations 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
Blood samples were collected for measurement of serum concentrations 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
Blood samples were collected for measurement of serum concentrations 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
Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented.
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
Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented.
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

Posted Jan 28, 2026

Participant flow

Participants were enrolled at 8 research centers in the United States (US) and Australia between July 2018 and April 2023.

Participant flow — Overall Study
Milestone	Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Started	20	6	6	6	6	6	9	9	5	6
Participants who received placebo in cohorts 1-5	10	0	0	0	0	0	0	0	0	0
Participants who received placebo in cohorts 6-9	10	0	0	0	0	0	0	0	0	0
Completed	17	6	4	6	2	3	8	6	5	5
Not completed	3	0	2	0	4	3	1	3	0	1
Withdrew: Withdrawal of consent from study	2	0	0	0	4	3	0	0	0	1
Withdrew: Decision by sponsor	0	0	0	0	0	0	1	3	0	0
Withdrew: Lost to follow-up	1	0	2	0	0	0	0	0	0	0

Outcome measures

PrimaryNumber 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.

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

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Participants	Cohorts 1-5: Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohorts 6-9: Placebo	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	5	3	3	5	1	0	7	6	3	4	4

SecondaryMaximum Observed Concentration (Cmax) of Olpasiran

Blood samples were collected for measurement of serum concentrations 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
Reported as:: Mean · ng/mL

Maximum Observed Concentration (Cmax) of Olpasiran
ng/mL	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Maximum Observed Concentration (Cmax) of Olpasiran	11.7 ± 2.36	36.1 ± 19.7	74.9 ± 25	252 ± 153	421 ± 223	17.4 ± 7.48	111 ± 56.3	1390 ± 947	2620 ± 888

SecondaryTime to Reach Cmax (Tmax) of Olpasiran

Blood samples were collected for measurement of serum concentrations 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
Reported as:: Median · hours

Time to Reach Cmax (Tmax) of Olpasiran
hours	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Time to Reach Cmax (Tmax) of Olpasiran	3.0 (1.0 to 9.0)	3.0 (3.0 to 6.0)	7.5 (1.0 to 9.0)	4.5 (0.17 to 9.0)	6.0 (1.0 to 12)	3.0 (1.0 to 9.0)	6.0 (3.0 to 24)	3.0 (1.0 to 23)	4.5 (2.1 to 6.2)

SecondaryArea 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.

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
Reported as:: Mean · hour*ng/mL

Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran
hour*ng/mL	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran	116 ± 39.8	352 ± 141	1020 ± 329	2830 ± 730	7800 ± 1670	240 ± 96.3	2060 ± 642	29600 ± 23500	44800 ± 16400

SecondaryChange From Baseline in Plasma Lp(a) Levels

Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented.

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
Reported as:: Mean · nmol/L

Change From Baseline in Plasma Lp(a) Levels
nmol/L	Cohorts 1-5: Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohorts 6-9: Placebo	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Change from baseline to Day 2	9.740 ± 11.415	-17.820 ± 16.662	-1.417 ± 9.409	9.412 ± 13.240	1.937 ± 2.589	-6.438 ± 14.001	-54.862 ± 91.381	-4.886 ± 24.160	-15.119 ± 79.070	-88.586 ± 105.991	-86.940 ± 134.234
Change from baseline to Day 4	11.450 ± 13.155	-13.020 ± 17.499	-8.317 ± 13.271	3.862 ± 12.344	-23.080 ± 12.246	-13.455 ± 11.489	-55.527 ± 100.807	-33.358 ± 21.037	-49.659 ± 70.520	-116.986 ± 71.397	-146.718 ± 165.278
Change from baseline to Day 7	0.410 ± 12.785	-24.170 ± 21.798	-35.283 ± 13.307	-32.272 ± 7.480	-45.863 ± 8.095	-69.188 ± 35.265	-32.389 ± 99.479	-77.707 ± 47.138	-102.508 ± 75.135	-203.215 ± 112.549	-204.990 ± 159.912
Change from baseline to Day 15	-2.530 ± 16.293	-59.137 ± 28.794	-76.094 ± 22.915	-63.772 ± 10.074	-96.580 ± 11.663	-98.938 ± 30.749	-35.367 ± 54.976	-138.618 ± 38.215	-208.459 ± 81.219	-277.226 ± 135.590	-294.890 ± 176.007
Change from baseline to Day 18	-6.940 ± 15.926	-71.070 ± 26.156	-85.594 ± 24.516	-76.222 ± 13.730	-108.463 ± 16.162	-122.205 ± 30.732	—	—	—	—	—
Change from baseline to Day 22	-3.450 ± 14.989	-77.853 ± 25.502	-93.714 ± 22.458	-79.388 ± 15.566	-117.813 ± 19.714	-126.788 ± 32.793	—	—	—	—	—
Change from baseline to Day 29	-1.350 ± 14.355	-82.037 ± 26.703	-104.894 ± 26.885	-86.038 ± 18.938	-124.713 ± 23.769	-134.605 ± 36.395	-46.909 ± 72.951	-188.740 ± 37.700	-270.641 ± 95.753	-330.115 ± 171.096	-366.214 ± 199.738
Change from baseline to Day 43	-7.720 ± 14.629	-89.787 ± 25.866	-108.734 ± 28.948	-90.072 ± 20.412	-129.230 ± 25.491	-140.572 ± 36.947	-33.244 ± 64.989	-197.673 ± 36.630	-282.841 ± 95.711	-257.585 ± 30.464	-351.707 ± 193.404
Change from baseline to Day 57	2.620 ± 11.739	-87.220 ± 29.478	-106.834 ± 27.834	-89.955 ± 20.435	-129.513 ± 26.035	-140.922 ± 36.663	-27.973 ± 104.520	-200.251 ± 40.105	-288.874 ± 100.724	-331.386 ± 166.191	-353.207 ± 193.827
Change from baseline to Day 71	-0.392 ± 14.313	-83.970 ± 24.076	-97.518 ± 24.356	-88.805 ± 22.440	-128.797 ± 26.709	-140.572 ± 37.216	—	—	—	—	—
Change from baseline to Day 85	2.497 ± 12.877	-73.953 ± 23.337	-96.318 ± 23.377	-85.072 ± 21.123	-127.980 ± 27.181	-139.255 ± 36.247	-35.246 ± 98.490	-185.407 ± 42.933	-275.519 ± 95.029	-330.806 ± 167.145	-352.923 ± 194.316
Change from baseline to Day 113	4.697 ± 6.955	-63.103 ± 28.733	-89.168 ± 24.019	-82.338 ± 24.960	-123.147 ± 26.883	-137.038 ± 36.491	-26.599 ± 83.420	-162.829 ± 50.183	-253.641 ± 93.836	-325.526 ± 168.995	-276.696 ± 75.437
Change from baseline to Day 155	-13.990 ± 14.136	—	—	-63.566 ± 26.356	-123.076 ± 29.946	-144.877 ± 24.157	-32.339 ± 101.724	-132.696 ± 52.950	-195.725 ± 50.429	-304.846 ± 173.370	-368.258 ± 212.962
Change from baseline to Day 183	-20.770 ± 10.748	—	—	—	-109.435 ± 31.304	-140.143 ± 25.143	-32.749 ± 77.047	-109.740 ± 41.868	-176.781 ± 51.330	-291.966 ± 167.126	-338.990 ± 202.609
Change from baseline to Day 225	-3.902 ± 18.584	—	—	-64.100 ± NA	-104.285 ± 36.607	-111.892 ± 27.648	-15.849 ± 70.823	-85.218 ± 39.572	-165.297 ± 89.184	-257.226 ± 167.618	-320.223 ± 207.672
Change from baseline to Day 253	—	—	—	—	—	—	-101.640 ± 58.930	—	—	-276.490 ± 179.094	-318.725 ± 259.063
Change from baseline to Day 281	—	—	—	—	—	—	-96.107 ± 81.127	—	—	-230.106 ± 164.525	-308.138 ± 230.671
Change from baseline to Day 309	—	—	—	—	—	—	-117.353 ± 34.739	—	—	-215.726 ± 168.115	-299.218 ± 232.143
Change from baseline to Day 337	—	—	—	—	—	—	-113.073 ± 84.006	—	—	-198.440 ± 162.932	-279.478 ± 231.897
Change from baseline to Day 365	—	—	—	—	—	—	-81.653 ± 81.061	—	—	-170.126 ± 146.154	-165.656 ± 88.637

SecondaryPercent 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.

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
Reported as:: Mean · percent change

Percent Change From Baseline in Plasma Lp(a) Levels
percent change	Cohorts 1-5: Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohorts 6-9: Placebo	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Percent change from baseline to Day 2	8.407 ± 8.491	-13.943 ± 11.951	-1.094 ± 7.699	8.295 ± 13.665	1.415 ± 1.925	-4.027 ± 9.484	-13.633 ± 21.683	-1.570 ± 10.443	-2.088 ± 20.604	-21.583 ± 17.410	-15.998 ± 20.674
Percent change from baseline to Day 4	11.483 ± 13.532	-9.649 ± 12.452	-6.487 ± 10.577	2.462 ± 12.152	-17.185 ± 7.985	-8.416 ± 5.613	-14.608 ± 23.141	-12.800 ± 8.339	-13.391 ± 16.046	-34.553 ± 16.231	-30.307 ± 21.326
Percent change from baseline to Day 7	0.684 ± 10.535	-17.968 ± 15.135	-30.135 ± 14.583	-34.017 ± 13.052	-34.398 ± 4.843	-46.725 ± 15.401	-7.196 ± 21.378	-29.518 ± 15.778	-30.979 ± 14.986	-58.222 ± 13.332	-53.069 ± 12.226
Percent change from baseline to Day 15	-1.586 ± 13.188	-46.805 ± 17.609	-61.995 ± 9.342	-65.000 ± 15.685	-72.512 ± 5.451	-69.051 ± 15.864	-8.425 ± 12.997	-53.145 ± 15.700	-66.742 ± 7.852	-82.712 ± 7.795	-81.166 ± 5.437
Percent change from baseline to Day 18	-5.992 ± 12.779	-56.826 ± 15.047	-69.643 ± 6.846	-76.332 ± 12.228	-81.178 ± 6.122	-84.107 ± 3.792	—	—	—	—	—
Percent change from baseline to Day 22	-3.064 ± 11.850	-62.268 ± 12.534	-77.121 ± 9.413	-79.157 ± 11.601	-87.780 ± 2.887	-87.062 ± 2.254	—	—	—	—	—
Percent change from baseline to Day 29	-1.630 ± 11.948	-65.771 ± 14.454	-85.794 ± 7.534	-85.001 ± 8.595	-92.577 ± 1.368	-92.124 ± 3.106	-14.805 ± 19.160	-72.210 ± 15.684	-85.371 ± 7.046	-95.448 ± 2.665	-95.872 ± 1.879
Percent change from baseline to Day 43	-6.503 ± 11.507	-72.060 ± 12.238	-88.761 ± 7.479	-88.558 ± 6.473	-95.843 ± 1.293	-96.365 ± 2.122	-12.075 ± 21.690	-75.430 ± 14.252	-89.637 ± 5.632	-98.226 ± 0.645	-98.499 ± 0.676
Percent change from baseline to Day 57	1.259 ± 10.313	-70.163 ± 17.697	-87.421 ± 9.001	-88.472 ± 6.147	-96.014 ± 2.073	-96.685 ± 1.316	-4.878 ± 25.711	-76.174 ± 13.755	-91.230 ± 6.742	-98.547 ± 0.677	-98.956 ± 0.400
Percent change from baseline to Day 71	-1.546 ± 12.389	-67.809 ± 13.524	-89.962 ± 4.968	-86.866 ± 5.779	-95.383 ± 2.145	-96.332 ± 1.963	—	—	—	—	—
Percent change from baseline to Day 85	1.275 ± 11.569	-59.413 ± 12.808	-88.913 ± 4.425	-83.628 ± 8.427	-94.747 ± 3.108	-95.517 ± 2.334	-7.875 ± 20.770	-70.536 ± 15.558	-87.328 ± 7.434	-98.275 ± 0.948	-98.814 ± 0.608
Percent change from baseline to Day 113	3.430 ± 7.307	-49.873 ± 16.496	-82.051 ± 7.297	-79.916 ± 11.140	-91.351 ± 6.866	-93.926 ± 2.891	-6.786 ± 24.282	-61.542 ± 17.396	-80.484 ± 11.668	-96.381 ± 3.343	-97.963 ± 1.142
Percent change from baseline to Day 155	-15.206 ± 14.391	—	—	-56.571 ± 13.156	-86.424 ± 11.607	-88.415 ± 3.561	-7.233 ± 28.936	-50.331 ± 20.523	-68.537 ± 15.584	-89.181 ± 10.167	-95.757 ± 4.528
Percent change from baseline to Day 183	-22.300 ± 6.289	—	—	—	-76.956 ± 26.029	-85.437 ± 4.356	-7.884 ± 23.516	-41.792 ± 16.749	-60.178 ± 18.037	-85.355 ± 11.214	-93.357 ± 5.554
Percent change from baseline to Day 225	-4.934 ± 17.577	—	—	-84.342 ± NA	-73.464 ± 29.532	-81.880 ± 11.062	-4.730 ± 23.419	-32.228 ± 14.640	-51.725 ± 20.701	-73.722 ± 17.160	-86.702 ± 12.646
Percent change from baseline to Day 253	—	—	—	—	—	—	-24.858 ± 11.199	—	—	-76.579 ± 15.153	-80.199 ± 18.262
Percent change from baseline to Day 281	—	—	—	—	—	—	-23.787 ± 22.538	—	—	-64.718 ± 19.802	-75.169 ± 20.243
Percent change from baseline to Day 309	—	—	—	—	—	—	-31.515 ± 2.142	—	—	-59.631 ± 21.986	-72.336 ± 19.971
Percent change from baseline to Day 337	—	—	—	—	—	—	-26.688 ± 15.875	—	—	-52.066 ± 26.070	-66.022 ± 23.528
Percent change from baseline to Day 365	—	—	—	—	—	—	-19.333 ± 15.319	—	—	-46.309 ± 23.019	-56.484 ± 19.999

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

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

Most frequent serious events

Most frequent serious events
Event	Cohorts 1-5: Placebo	Cohorts 6-9: Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Non-cardiac chest painGeneral disorders	0/10	1/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	0/5	0/6
Cardiac telemetry abnormalInvestigations	0/10	1/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	0/5	0/6

Most frequent other events

Showing 10 of 64

Most frequent other events
Event	Cohorts 1-5: Placebo	Cohorts 6-9: Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg
Urinary tract infectionInfections and infestations	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	2/5	0/6
Upper respiratory tract infectionInfections and infestations	1/10	1/10	2/6	0/6	2/6	0/6	0/6	2/9	0/9	0/5	0/6
HeadacheNervous system disorders	1/10	3/10	0/6	0/6	0/6	0/6	0/6	2/9	2/9	0/5	0/6
Abdominal discomfortGastrointestinal disorders	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6
Injection site haemorrhageGeneral disorders	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6
Injection site painGeneral disorders	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	1/6
COVID-19Infections and infestations	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6
CystitisInfections and infestations	0/10	0/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6
GastroenteritisInfections and infestations	0/10	1/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6
SinusitisInfections and infestations	0/10	1/10	0/6	0/6	0/6	0/6	0/6	0/9	0/9	1/5	0/6

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)	Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg	Total
Mean	52.0 ± 8.8	42.7 ± 16.0	50.2 ± 7.6	34.5 ± 11.5	51.5 ± 13.4	40.8 ± 14.3	52.7 ± 10.8	52.8 ± 8.3	58.2 ± 4.3	47.7 ± 13.1	49.2 ± 11.8

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg	Total
Female	9	3	2	1	3	0	3	3	4	1	29
Male	11	3	4	5	3	6	6	6	1	5	50

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg	Total
Hispanic or Latino	8	6	6	4	1	2	2	3	0	0	32
Not Hispanic or Latino	12	0	0	2	5	4	7	6	5	6	47
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Cohort 1: Olpasiran 3 mg	Cohort 2: Olpasiran 9 mg	Cohort 3: Olpasiran 30 mg	Cohort 4 Olpasiran: 75 mg	Cohort 5 Olpasiran: 225 mg	Cohort 6: Olpasiran 9 mg	Cohort 7: Olpasiran 75 mg	Cohort 8: Olpasiran 225 mg	Cohort 9: Olpasiran 675 mg	Total
American Indian or Alaska Native	0	0	0	0	0	0	1	0	0	0	1
Asian	0	0	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Black or African American	3	4	0	1	3	1	1	0	0	1	14
White	16	2	6	5	3	5	7	9	5	5	63
More than one race	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	0	0	0	0	0	0	0	0	1

Study locations

9 sites

Orange County Research Center
Tustin, California 92780, United States
Excel Medical Clinical Trials
Boca Raton, Florida 33434, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216, United States
QPS Miami Research Associates
South Miami, Florida 33143, United States
University of Kansas Medical Center
Kansas City, Kansas 66160, United States
New York University
New York, New York 10016, United States
Medpace Inc
Cincinnati, Ohio 45227, United States
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia 5000, Australia
Linear Clinical Research Limited
Nedlands, Western Australia 6009, Australia

References and documents

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 ↗

Study documents

Study protocol · Dec 7, 2021
Statistical analysis plan · Mar 8, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03626662
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Aug 13, 2018
Start date: Jul 30, 2018
Primary completion: Apr 18, 2023
Completion: Apr 18, 2023
Results posted: Jan 28, 2026
Last update: Jan 28, 2026

Study contacts

study director · Amgen

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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

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