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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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)
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Secondary ID [1]
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20170544
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Subject incidence of treatment-emergent adverse events
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Assessment method [1]
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Timepoint [1]
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up to 365 days
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Primary outcome [2]
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Changes in blood pressure
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Assessment method [2]
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The analysis will include summary statistics at selected time points by treatment group.
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Timepoint [2]
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Up to 365 days
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Primary outcome [3]
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Changes in heart rate
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Assessment method [3]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [3]
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Up to 365 days
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Primary outcome [4]
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Changes in respiratory rate
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Assessment method [4]
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The analysis will include summary statistics at selected time points by treatment group.
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Timepoint [4]
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Up to 365 days
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Primary outcome [5]
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Changes in temperature
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Assessment method [5]
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The analysis will include summary statistics at selected time points by treatment group.
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Timepoint [5]
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Up to 365 days
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Primary outcome [6]
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Changes in QRS interval
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Assessment method [6]
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The analysis will include summary statistics at selected time points by treatment group.
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Timepoint [6]
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Up to 365 days
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Primary outcome [7]
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Changes in PR interval
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Assessment method [7]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [7]
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Up to 365 days
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Primary outcome [8]
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Changes in QT interval
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Assessment method [8]
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The analysis will include summary statistics at selected time points by treatment group.
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Timepoint [8]
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Up to 365 days
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Primary outcome [9]
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Changes in RR interval
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Assessment method [9]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [9]
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Up to 365 days
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Primary outcome [10]
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Changes in red blood cells
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Assessment method [10]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [10]
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Up to 365 days
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Primary outcome [11]
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Changes in platelets
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Assessment method [11]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [11]
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Up to 365 days
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Primary outcome [12]
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Changes in white blood cells
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Assessment method [12]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [12]
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Up to 365 days
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Primary outcome [13]
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Changes in prothrombin time (PT)
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Assessment method [13]
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Timepoint [13]
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Up to 365 days
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Primary outcome [14]
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Changes in international normalized ratio (INR)
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Assessment method [14]
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Timepoint [14]
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Up to 365 days
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Primary outcome [15]
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Changes in activated partial thromboplastin time (aPTT)
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Assessment method [15]
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Timepoint [15]
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Up to 365 days
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Primary outcome [16]
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Changes in Thrombin time (TT)
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Assessment method [16]
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Timepoint [16]
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Up to 365 days
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Primary outcome [17]
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Changes in aspartate aminotransferase (AST) levels (units: U/L)
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Assessment method [17]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [17]
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Up to 365 days
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Primary outcome [18]
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Changes in alanine aminotransferase (ALT) levels (units: U/L)
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Assessment method [18]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [18]
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Up to 365 days
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Primary outcome [19]
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Changes in total bilirubin levels (units: µmol/L)
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Assessment method [19]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [19]
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Up to 365 days
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Primary outcome [20]
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Changes in direct bilirubin levels (units: µmol/L)
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Assessment method [20]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [20]
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Up to 365 days
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Primary outcome [21]
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Changes in alkaline phosphatase levels (units: U/L)
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Assessment method [21]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [21]
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Up to 365 days
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Primary outcome [22]
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Changes in total protein levels (units: g/L)
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Assessment method [22]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [22]
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Up to 365 days
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Primary outcome [23]
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Changes in albumin levels (units: g/L)
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Assessment method [23]
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The analysis will include summary statistics at selected time points by treatment group
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Timepoint [23]
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Up to 365 days
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Secondary outcome [1]
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Pharmacokinetics parameter of maximum observed concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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up to 365 days
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Secondary outcome [2]
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Pharmacokinetics parameter of time of maximum observed concentration (tmax)
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Assessment method [2]
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Timepoint [2]
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up to 365 days
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Secondary outcome [3]
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Pharmacokinetics parameter of area under the concentration time curve (AUC)
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Assessment method [3]
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Timepoint [3]
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up to 365 days
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Secondary outcome [4]
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Change in plasma Lp(a) over time
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Assessment method [4]
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Timepoint [4]
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Up to 365 days
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Secondary outcome [5]
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Percent change in plasma Lp(a) over time
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Assessment method [5]
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Timepoint [5]
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Up to 365 days
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/04/2023
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Sample size
Target
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Accrual to date
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Final
79
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Clinical Medical and Analytical eXellence CMAX - Adelaide
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Recruitment hospital [2]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03626662
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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.
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03626662
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