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

JRCT ID: jRCT2031230320

Registered date:04/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hypercholesterolaemia
• Date of first enrollment: 19/09/2023
• Target sample size: 170
• Countries of recruitment: USA,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 type: Interventional

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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Kobayashi Masayuki
• Secondary ID(s): NCT05952856