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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and when Coadministered with Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)

A Phase 2 Study of MK-7262 and Enlicitide in Adults with Elevated Lp(a)

Kobayashi Masayuki

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Oct. 09, 2026

Interventional

randomized controlled trial

double blind

placebo control

factorial assignment

treatment purpose

- Has Lp(a) >= 150 nmol/L.
- Is receiving an optimized and stable dose of statin for >= 30 days with no planned additions, dose changes, or discontinuations through the duration of the study.

- Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
- Has a history of class IV heart failure, severe systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization.
- Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load).
- Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection.
- Has a history of nephrotic syndrome.
- Has severe renal insufficiency.
- Has received certain therapies in the prohibited timeframe as specified in the protocol.
- Has active or chronic hepatobiliary or hepatic disease.
- Has poorly controlled Type 1 or Type 2 diabetes.

Both

Lipoprotein (a) increased

- MK-7262
- Enlicitide
- Placebo for MK-7262
- Placebo for enlicitide

- Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. placebo, MK-7262 monotherapy vs. placebo, MK-7262 + enlicitide vs. enlicitide monotherapy)
- Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. placebo, MK-7262 + enlicitide vs. MK-7262 monotherapy)
- Number of Participants who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Intervention Due to an AE

- Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)
- Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)
- Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)
- Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)
- Percentage of Participants with Lp(a) <125 nmol/L at Week 8
- Percentage of Participants with Lp(a) <75 nmol/L at Week 8
- Percent Change from Baseline in Lp(a) at Week 12
- Percent Change from Baseline in LDL-C at Week 12

+81-22-346-0325

July. 22, 2026

Yes

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