A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease
1 other identifier
interventional
133
1 country
23
Brief Summary
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
Shorter than P25 for phase_2
23 active sites
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
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedResults Posted
Study results publicly available
December 19, 2019
CompletedMarch 23, 2020
March 1, 2020
11 months
October 12, 2017
November 8, 2019
March 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Day 1 (Baseline) through Day 241
Secondary Outcomes (6)
Change From Baseline in Apolipoprotein B
Day 1 (Baseline), and Days 31, 61, and 91
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Day 1 (Baseline), and Days 31, 61, and 91
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
- +1 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORParticipants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg
EXPERIMENTALParticipants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg
EXPERIMENTALParticipants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg
EXPERIMENTALParticipants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg
EXPERIMENTALParticipants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg
EXPERIMENTALParticipants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
Interventions
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Eligibility Criteria
You may qualify if:
- Diagnosis of stable coronary heart disease prior to screening
- Currently receiving high intensity statin(s)
You may not qualify if:
- Unstable cardiovascular conditions
- Any planned arterial revascularizations
- Fasting Laboratory values at screening: Triglycerides \> 500 mg/dl, Low Density Lipoprotein-Cholesterol \> 100 mg/dL
- Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (23)
Research Site
Anniston, Alabama, 36207, United States
Research Site
Huntsville, Alabama, 35801, United States
Research Site
El Cajon, California, 92020, United States
Research Site
Lincoln, California, 95648, United States
Research Site
Northridge, California, 91325, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Fleming Island, Florida, 32003, United States
Research Site
Jacksonville, Florida, 32216, United States
Research Site
Pembroke Pines, Florida, 33024, United States
Research Site
Port Orange, Florida, 32127, United States
Research Site
Savannah, Georgia, 31406, United States
Research Site
Evanston, Illinois, 60201, United States
Research Site
Indianapolis, Indiana, 46260, United States
Research Site
Louisville, Kentucky, 40213, United States
Research Site
Fargo, North Dakota, 58103, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Marion, Ohio, 43302, United States
Research Site
Stow, Ohio, 44224, United States
Research Site
Oklahoma City, Oklahoma, 73134, United States
Research Site
Rapid City, South Dakota, 57701, United States
Research Site
Kingsport, Tennessee, 37660, United States
Research Site
McAllen, Texas, 78503, United States
Research Site
San Antonio, Texas, 78228, United States
Related Publications (1)
Ruff CT, Koren MJ, Grimsby J, Rosenbaum AI, Tu X, Karathanasis SK, Falloon J, Hsia J, Guan Y, Conway J, Tsai LF, Hummer BT, Hirshberg B, Kuder JF, Murphy SA, George RT, Sabatine MS. LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 Dec;41(12):3005-3014. doi: 10.1161/ATVBAHA.120.315757. Epub 2021 Oct 28.
PMID: 34706556DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard George
- Organization
- MedImmune, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Koren, MD, FACC
Jacksonville Center For Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2017
First Posted
November 24, 2017
Study Start
December 13, 2017
Primary Completion
November 9, 2018
Study Completion
November 9, 2018
Last Updated
March 23, 2020
Results First Posted
December 19, 2019
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share