Dyslipidemia, Hypercholesterolemia
Conditions
Brief summary
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.
Interventions
OTHERTest Meal
During Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal.
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant has an LDL-C ranging from ≥100 mg/dL to \<160 mg/dL. * Patient has a triglyceride (TG) level of ≤500 mg/dL.
Exclusion criteria
* Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period). * Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal \[ULN\]) * Participant has increased creatine kinase (CK) (≥2 x ULN). * Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus. * Participant has a history of alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) | up to 6 hours after Test Meal | ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Mean ApoB-48 Peak Levels | up to 6 hours after Test Meal | ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe. |
| Fasting ApoB-48 Levels | Baseline (Hour 0) | ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0). |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetic Participants Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein. | 43 |
| Nondiabetic Participants Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein). | 50 |
| Total | 93 |
Baseline characteristics
| Characteristic | Diabetic Participants | Nondiabetic Participants | Total |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 11.5 | 46.0 years STANDARD_DEVIATION 13.6 | 49.7 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Male | 22 Participants | 26 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 50 |
| serious Total, serious adverse events | 0 / 43 | 0 / 50 |
Outcome results
Primary
Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
Time frame: up to 6 hours after Test Meal
Population: Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic Participants | Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) | 63.4 μg/mL x h | Standard Deviation 42.4 |
| Nondiabetic Participants | Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) | 41.7 μg/mL x h | Standard Deviation 30.9 |
p-value: 0.0078t-test, 2 sided
Secondary
Fasting ApoB-48 Levels
ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Time frame: Baseline (Hour 0)
Population: Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic Participants | Fasting ApoB-48 Levels | 5.9 μg/mL | Standard Deviation 3.5 |
| Nondiabetic Participants | Fasting ApoB-48 Levels | 7.3 μg/mL | Standard Deviation 5.8 |
p-value: 0.1798t-test, 2 sided
Secondary
Postprandial Mean ApoB-48 Peak Levels
ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.
Time frame: up to 6 hours after Test Meal
Population: Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic Participants | Postprandial Mean ApoB-48 Peak Levels | 24.8 μg/mL | Standard Deviation 15.7 |
| Nondiabetic Participants | Postprandial Mean ApoB-48 Peak Levels | 19.3 μg/mL | Standard Deviation 11.9 |
p-value: 0.0675t-test, 2 sided