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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02100839
Registration number
NCT02100839
Ethics application status
Date submitted
27/03/2014
Date registered
1/04/2014
Date last updated
29/12/2015
Titles & IDs
Public title
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AEM-28 in Healthy Subjects and Patients With Refractory Hypercholesterolemia
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Secondary ID [1]
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LPMX-112
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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:
Hypercholesterolemia
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Hyperlipoproteinemia Type II
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AEM-28
Treatment: Drugs - Normal Saline
Experimental: AEM-28 - Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.
Placebo comparator: Normal Saline - Single Ascending Dose: Single IV dose for each cohort.
Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.
Treatment: Drugs: AEM-28
Solution for injection
Treatment: Drugs: Normal Saline
0.9% saline for injection
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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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Number of Participants Who Incurred at Least One Treatment Emergent Event
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Assessment method [1]
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Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
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Timepoint [1]
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Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
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Primary outcome [2]
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Number of Participants Who Incurred Mild Treatment Emergent Adverse Events
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Assessment method [2]
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Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
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Timepoint [2]
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Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
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Primary outcome [3]
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Number of Participants Who Incurred Moderate Treatment Emergent Events
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Assessment method [3]
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Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
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Timepoint [3]
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Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
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Secondary outcome [1]
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Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change
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Assessment method [1]
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Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.
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Timepoint [1]
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Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57
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Eligibility
Key inclusion criteria
Single Ascending Dose (SAD) Study:
* Male or female non-smoker, =18 and =55 years of age, with BMI >18.5 and < 32.0 kg/m²
* Total cholesterol greater or equal to 5.0 mmol/L (=194 mg/dL) at screening
Multiple Ascending Dose (MAD) Study:
* Male or female non-smoker, =18 and =75 years of age, with BMI >18.5 and < 35.0 kg/m²
* Diagnosis of refractory hypercholesterolemia with LDL cholesterol levels > 2.5 mmol/L (97 mg/mL) at screening.
* On stable lipid lowering therapy for = 8 weeks
* On stable diet for = 12 weeks.
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Minimum age
18
Years
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Maximum age
75
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
SAD Study:
* Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
* History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.
MAD Study:
* Significant health problems within 6 months prior to screening, which in the opinion of the Medical Sub-Investigator would prevent the subject from participating in the study, including but not limited to: unstable coronary heart disease; transient ischemic attack; stroke; revascularization procedure; uncontrolled hyperthyroidism; coagulation disorder; peptic ulcers or GI bleeding; significant disease of the central nervous system; liver or renal disease.
* History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.
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Study design
Purpose of the study
Treatment
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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 assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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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
1/03/2014
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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
1/12/2014
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Linear Clinical Research Ltd. - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
LipimetiX Development, LLC
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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
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia. AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.
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Trial website
https://clinicaltrials.gov/study/NCT02100839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janakan Krishnarajah, MBBS, FRACP
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Address
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Linear Clinical Research
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02100839
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