Trial Outcomes & Findings for Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism (NCT NCT03773172)
NCT ID: NCT03773172
Last Updated: 2024-11-12
Results Overview
FCR is the rate of synthesis and clearance of soluble lipoprotein B in participants per day.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 48 hours from first dose
Results posted on
2024-11-12
Participant Flow
7 participants were enrolled; 2 participants withdrew consent prior to randomization and therefore were not included in the Participant Flow.
Participant milestones
| Measure |
MEDI6012 First, Then Placebo
Participants will receive IV push loading dose of 300 mg MEDI6012on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg MEDI6012. After a 6-8 washout period, the participants will repeat the same protocol but will receive the placebo.
|
Placebo, Then MEDI6012
Participants will receive IV push loading dose of 300 mg placebo on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg placebo. After a 6-8 washout period, the participants will repeat the same protocol but will receive MEDI6012.
|
|---|---|---|
|
First Intervention (3 Days)
STARTED
|
2
|
3
|
|
First Intervention (3 Days)
COMPLETED
|
2
|
3
|
|
First Intervention (3 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (6 to 8 Weeks)
STARTED
|
2
|
3
|
|
Washout (6 to 8 Weeks)
COMPLETED
|
2
|
3
|
|
Washout (6 to 8 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Days)
STARTED
|
2
|
3
|
|
Second Intervention (3 Days)
COMPLETED
|
2
|
3
|
|
Second Intervention (3 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism
Baseline characteristics by cohort
| Measure |
Placebo Control or Active Treatment
n=7 Participants
Subjects will receive placebo treatment to mimic active treatment. Placebo: The placebo will mimic the active treatment.
OR
IV push loading dose of 300 mg MEDI6012 followed by a 150 mg maintenance dose of MEDI6012 at 48 hours.
MEDI6012: MEDI6012 is recombinant human lecithin-cholesterol acyltransferase (rhLCAT), an approximately 60 kilodalton, glycosylated, single-chain protein consisting of 416 amino acids produced via Chinese hamster ovary cell culture. It is being explored as an acute treatment to reduce the risk of recurrent cardiovascular events as an adjunct to the standard of care in patients with acute myocardial infarction (MI). MEDI6012 and ACP501 have the identical amino acid sequence and are therefore considered the same molecular entity.
(Study is double-blind)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours from first doseFCR is the rate of synthesis and clearance of soluble lipoprotein B in participants per day.
Outcome measures
| Measure |
MEDI6012
n=5 Participants
Participants will receive IV push loading dose of 300 mg MEDI6012on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg MEDI6012.
|
Placebo
n=5 Participants
Participants will receive IV push loading dose of 300 mg placebo on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg placebo.
|
|---|---|---|
|
Fractional Clearance Rate (FCR) of Lipoprotein B (Pools/Day)
|
14.0 pools/day
Standard Deviation 6.0
|
10.0 pools/day
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Up to 48 hours from first doseAmount of Apolipoprotein B100 (measured as mg/kg) produced in participants per day.
Outcome measures
| Measure |
MEDI6012
n=5 Participants
Participants will receive IV push loading dose of 300 mg MEDI6012on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg MEDI6012.
|
Placebo
n=5 Participants
Participants will receive IV push loading dose of 300 mg placebo on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg placebo.
|
|---|---|---|
|
Production Rate (PR) of Apolipoprotein B100 (mg/kg/Day)
|
14.2 mg/kg/day
Standard Deviation 11.3
|
15.7 mg/kg/day
Standard Deviation 3.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 days post administration of first dosePopulation: Double-blind study terminated early due to COVID-19. Data was not collected for this outcome measure and therefore cannot be analyzed.
To access the immunogenicity of MEDI6012, anti-drug antibodies (ADA) will be measured.
Outcome measures
Outcome data not reported
Adverse Events
MEDI6012
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MEDI6012
n=5 participants at risk
Participants will receive IV push loading dose of 300 mg MEDI6012on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg MEDI6012.
|
Placebo
n=5 participants at risk
Participants will receive IV push loading dose of 300 mg placebo on Day 0. On Day 2 (exactly 48 hours from Day 0 administration), they will receive the 2nd dose of 300 mg placebo.
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
20.0%
1/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
|
Eye disorders
Blurry vision
|
0.00%
0/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
20.0%
1/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
|
General disorders
Insomnia
|
0.00%
0/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
20.0%
1/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
|
General disorders
Dyspnea
|
0.00%
0/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
20.0%
1/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
|
General disorders
Flushing
|
20.0%
1/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
0.00%
0/5 • Up to 60 days post administration of first dose.
Data for Adverse Events were collected agnostic to the intervention.
|
Additional Information
Henry Ginsberg, MD
Columbia University Irving Medical Center
Phone: 212-305-9562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place