Trial Outcomes & Findings for A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006) (NCT NCT00687271)

Results Overview

Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

334 participants

Primary outcome timeframe

Baseline (predose) and Week 4

Results posted on

2019-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	MK-6213 160 mg + Atorvastatin 20 mg 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Overall Study STARTED	94	96	96	48
Overall Study Treated	94	95	96	48
Overall Study COMPLETED	91	90	91	48
Overall Study NOT COMPLETED	3	6	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-6213 160 mg + Atorvastatin 20 mg 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks
Overall Study Adverse Event	1	3	1
Overall Study Lost to Follow-up	0	1	0
Overall Study Protocol Violation	2	1	1
Overall Study Withdrawal by Subject	0	1	3

Baseline Characteristics

A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=94 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=96 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=96 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=48 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks	Total n=334 Participants Total of all reporting groups
Age, Continuous	52.9 Years STANDARD_DEVIATION 10.9 • n=5 Participants	53.6 Years STANDARD_DEVIATION 10.2 • n=7 Participants	56.2 Years STANDARD_DEVIATION 10.0 • n=5 Participants	54.7 Years STANDARD_DEVIATION 10.7 • n=4 Participants	54.3 Years STANDARD_DEVIATION 10.5 • n=21 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	60 Participants n=7 Participants	47 Participants n=5 Participants	26 Participants n=4 Participants	178 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	36 Participants n=7 Participants	49 Participants n=5 Participants	22 Participants n=4 Participants	156 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	-50.7 Percentage Change Interval -53.8 to -47.5	-40.6 Percentage Change Interval -43.8 to -37.4	-13.3 Percentage Change Interval -16.5 to -0.1	4.6 Percentage Change Interval 0.2 to 9.1

SECONDARY outcome

Timeframe: Up to 14 days post last dose of study drug (up to 6 weeks)

Population: All participants that received at least 1 dose for study drug.

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=94 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=95 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=96 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=48 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)	33.0 Percentage of Participants	37.9 Percentage of Participants	29.2 Percentage of Participants	41.7 Percentage of Participants

SECONDARY outcome

Timeframe: up to 4 weeks

Population: All participants that received at least 1 dose for study drug.

An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=94 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=95 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=96 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=48 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage of Participants That Had Study Drug Discontinued Due to an AE	1.1 Percentage of Participants	3.1 Percentage of Participants	1.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	-46.6 Percentage Change Interval -49.5 to -43.6	-38.0 Percentage Change Interval -41.0 to -35.0	-11.4 Percentage Change Interval -14.3 to -8.5	2.5 Percentage Change Interval -1.6 to 6.6

SECONDARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in Apolipoprotein B (ApoB)	-40.4 Percentage Change Interval -43.1 to -37.7	-32.7 Percentage Change Interval -35.4 to -30.0	-8.8 Percentage Change Interval -11.5 to -6.1	3.5 Percentage Change Interval -0.3 to 7.2

SECONDARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in Total Cholesterol (TC)	-35.1 Percentage Change Interval -37.4 to -32.7	-27.6 Percentage Change Interval -30.0 to -25.2	-8.5 Percentage Change Interval -10.9 to -6.2	2.5 Percentage Change Interval -0.8 to 5.8

SECONDARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in HDL-C	3.8 Percentage Change Interval 0.9 to 6.8	6.2 Percentage Change Interval 3.2 to 9.2	1.4 Percentage Change Interval -1.6 to 4.3	2.1 Percentage Change Interval -2.1 to 6.2

SECONDARY outcome

Timeframe: Baseline (predose) and Week 4

Population: All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint.

Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized.

Outcome measures

Outcome measures
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=89 Participants 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=92 Participants 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=47 Participants 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Percentage Change From Baseline in TG	-24.2 Percentage of Participants Interval -29.6 to -18.9	-25.9 Percentage of Participants Interval -32.1 to -19.7	1.6 Percentage of Participants Interval -6.9 to 10.1	-7.1 Percentage of Participants Interval -17.2 to 3.0

Adverse Events

MK-6213 160 mg + Atorvastatin 20 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Atorvastatin 20 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MK-6213 160 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-6213 160 mg + Atorvastatin 20 mg n=94 participants at risk 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks	Atorvastatin 20 mg n=95 participants at risk 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks	MK-6213 160 mg n=96 participants at risk 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks	Placebo n=48 participants at risk 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Nervous system disorders Headache	3.2% 3/94 • Number of events 3 • up to 2 weeks post last dose (up to 6 weeks total) Population included all participants that received at least 1 dose of study drug.	5.3% 5/95 • Number of events 7 • up to 2 weeks post last dose (up to 6 weeks total) Population included all participants that received at least 1 dose of study drug.	5.2% 5/96 • Number of events 6 • up to 2 weeks post last dose (up to 6 weeks total) Population included all participants that received at least 1 dose of study drug.	4.2% 2/48 • Number of events 2 • up to 2 weeks post last dose (up to 6 weeks total) Population included all participants that received at least 1 dose of study drug.

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 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. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines
Publication restrictions are in place

Restriction type: OTHER