NCT03626662

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

June 19, 2018

Results QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single Ascending Dose Cohorts

Drug: Placebo

AMG 890

EXPERIMENTAL

Single Ascending Dose Cohorts

Drug: AMG 890

Interventions

AMG 890DRUG

Ascending Single Doses of AMG 890

AMG 890
PlaceboDRUG

Calculated volume to match experimental drug.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Orange County Research Center

Tustin, California, 92780, United States

Location

Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

QPS Miami Research Associates

South Miami, Florida, 33143, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

New York University

New York, New York, 10016, United States

Location

Medpace Inc

Cincinnati, Ohio, 45227, United States

Location

Clinical Medical and Analytical eXellence CMAX

Adelaide, South Australia, 5000, Australia

Location

Linear Clinical Research Limited

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

  • 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.

    PMID: 35027752BACKGROUND

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
medinfo@amgen.com
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The subjects and the investigative site staff, except for the unblinded pharmacist, will be blinded to treatment assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

August 13, 2018

Study Start

July 30, 2018

Primary Completion

April 18, 2023

Study Completion

April 18, 2023

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
More information

Locations

AU(2)US(7)