NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031230320

Registered date:04/09/2023

A Phase 3 Study of MK-0616 in Adults With Hypercholesterolemia

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHypercholesterolaemia
Date of first enrollment19/09/2023
Target sample size170
Countries of recruitmentUSA,Japan,Germany,Japan,Israel,Japan,Italy,Japan,South Africa,Japan,Spain,Japan,Turkey,Japan,South Korea,Japan,Taiwan,Japan,Argentina,Japan,Colombia,Japan,Mexico,Japan,China,Japan
Study typeInterventional
Intervention(s)Experimental: MK-0616 Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks. Placebo Comparator: Placebo Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.

Outcome(s)

Primary Outcome-Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 -Number of participants with one or more adverse events (AEs) -Number of participants who discontinue study drug due to an AE
Secondary Outcome-Mean percent change from baseline in LDL-C at Week 52 -Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24 -Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24 -Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24 -Percentage of participants with LDL-C <70 mg/dL and >=50% reduction from baseline at Week 24 -Percentage of participants with LDL-C <55 mg/dL and >=50% reduction from baseline at Week 24

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria-Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C >=55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C >=70 mg/dL note:To be eligible for the study, participants in Japan must require additional LDL-C reduction according to JAS guideline recommendations at https://www.j-athero.org/jp/jas_gl2022/. -Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance -If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change
Exclude criteria-Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH -Has a history of heart failure or heart failure hospitalization within 3 months before first study visit -Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program -Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Related Information

Contact

Public contact
Name MSDJRCT inquiry mailbox
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.
Scientific contact
Name Tanaka Yoshiyuki
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.