Trial Outcomes & Findings for A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1) (NCT NCT01333436)

Results Overview

ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

up to 6 hours after Test Meal

Results posted on

2024-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	43	50
Overall Study COMPLETED	43	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic Participants n=43 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.	Nondiabetic Participants n=50 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).	Total n=93 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	46.0 years STANDARD_DEVIATION 13.6 • n=7 Participants	49.7 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.

Outcome measures

Outcome measures
Measure	Diabetic Participants n=42 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).	Nondiabetic Participants n=46 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).
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	41.7 μg/mL x h Standard Deviation 30.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Diabetic Participants n=42 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).	Nondiabetic Participants n=46 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).
Postprandial Mean ApoB-48 Peak Levels	24.8 μg/mL Standard Deviation 15.7	19.3 μg/mL Standard Deviation 11.9

SECONDARY outcome

Timeframe: 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.

ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).

Outcome measures

Outcome measures
Measure	Diabetic Participants n=42 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).	Nondiabetic Participants n=46 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).
Fasting ApoB-48 Levels	5.9 μg/mL Standard Deviation 3.5	7.3 μg/mL Standard Deviation 5.8

Adverse Events

Diabetic Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nondiabetic Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER