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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03626662




Registration number
NCT03626662
Ethics application status
Date submitted
19/06/2018
Date registered
13/08/2018
Date last updated
18/10/2023

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Scientific 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)
Secondary ID [1] 0 0
20170544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 890
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Single Ascending Dose Cohorts

Experimental: AMG 890 - Single Ascending Dose Cohorts


Treatment: Drugs: AMG 890
Ascending Single Doses of AMG 890

Treatment: Drugs: Placebo
Calculated volume to match experimental drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of treatment-emergent adverse events
Timepoint [1] 0 0
up to 365 days
Primary outcome [2] 0 0
Changes in blood pressure
Timepoint [2] 0 0
Up to 365 days
Primary outcome [3] 0 0
Changes in heart rate
Timepoint [3] 0 0
Up to 365 days
Primary outcome [4] 0 0
Changes in respiratory rate
Timepoint [4] 0 0
Up to 365 days
Primary outcome [5] 0 0
Changes in temperature
Timepoint [5] 0 0
Up to 365 days
Primary outcome [6] 0 0
Changes in QRS interval
Timepoint [6] 0 0
Up to 365 days
Primary outcome [7] 0 0
Changes in PR interval
Timepoint [7] 0 0
Up to 365 days
Primary outcome [8] 0 0
Changes in QT interval
Timepoint [8] 0 0
Up to 365 days
Primary outcome [9] 0 0
Changes in RR interval
Timepoint [9] 0 0
Up to 365 days
Primary outcome [10] 0 0
Changes in red blood cells
Timepoint [10] 0 0
Up to 365 days
Primary outcome [11] 0 0
Changes in platelets
Timepoint [11] 0 0
Up to 365 days
Primary outcome [12] 0 0
Changes in white blood cells
Timepoint [12] 0 0
Up to 365 days
Primary outcome [13] 0 0
Changes in prothrombin time (PT)
Timepoint [13] 0 0
Up to 365 days
Primary outcome [14] 0 0
Changes in international normalized ratio (INR)
Timepoint [14] 0 0
Up to 365 days
Primary outcome [15] 0 0
Changes in activated partial thromboplastin time (aPTT)
Timepoint [15] 0 0
Up to 365 days
Primary outcome [16] 0 0
Changes in Thrombin time (TT)
Timepoint [16] 0 0
Up to 365 days
Primary outcome [17] 0 0
Changes in aspartate aminotransferase (AST) levels (units: U/L)
Timepoint [17] 0 0
Up to 365 days
Primary outcome [18] 0 0
Changes in alanine aminotransferase (ALT) levels (units: U/L)
Timepoint [18] 0 0
Up to 365 days
Primary outcome [19] 0 0
Changes in total bilirubin levels (units: µmol/L)
Timepoint [19] 0 0
Up to 365 days
Primary outcome [20] 0 0
Changes in direct bilirubin levels (units: µmol/L)
Timepoint [20] 0 0
Up to 365 days
Primary outcome [21] 0 0
Changes in alkaline phosphatase levels (units: U/L)
Timepoint [21] 0 0
Up to 365 days
Primary outcome [22] 0 0
Changes in total protein levels (units: g/L)
Timepoint [22] 0 0
Up to 365 days
Primary outcome [23] 0 0
Changes in albumin levels (units: g/L)
Timepoint [23] 0 0
Up to 365 days
Secondary outcome [1] 0 0
Pharmacokinetics parameter of maximum observed concentration (Cmax)
Timepoint [1] 0 0
up to 365 days
Secondary outcome [2] 0 0
Pharmacokinetics parameter of time of maximum observed concentration (tmax)
Timepoint [2] 0 0
up to 365 days
Secondary outcome [3] 0 0
Pharmacokinetics parameter of area under the concentration time curve (AUC)
Timepoint [3] 0 0
up to 365 days
Secondary outcome [4] 0 0
Change in plasma Lp(a) over time
Timepoint [4] 0 0
Up to 365 days
Secondary outcome [5] 0 0
Percent change in plasma Lp(a) over time
Timepoint [5] 0 0
Up to 365 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/04/2023
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Clinical Medical and Analytical eXellence CMAX - Adelaide
Recruitment hospital [2] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03626662
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03626662