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NCT Number: NCT07614984

A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C).

The goals of this trial are to evaluate:

* if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood * if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood * the safety and tolerability of taking MK-7262 and enlicitide alone and together

Recruiting

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Key information

Conditions

Lipoprotein(a)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Cardiovascular - Alexander City ( Site 0158), Alexander City, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • 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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
  • Has a history of class IV heart failure, severe ventricular 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

Treatment and study plan

MK-7262

Drug

Oral Coated Tablet

Other names: HRS-5346

Enlicitide

Drug

Oral Coated Tablet

Other names: MK-0616, enlicitide decanoate

Placebo for MK-7262

Drug

Oral Coated Tablet

Placebo for enlicitide

Drug

Oral Coated Tablet

Primary outcomes

  1. Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).

  2. Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.

  3. Number of Participants who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 20 Weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  4. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 12 Weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary outcomes

  1. Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with enlicitide monotherapy versus placebo.

  2. Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 monotherapy versus placebo.

  3. Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in Lp(a) between participants treated with MK-7262 + enlicitide versus MK-7262 monotherapy.

  4. Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)

    Time frame: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 + enlicitide versus enlicitide monotherapy.

  5. Percentage of Participants with Lp(a) <125 nmol/L at Week 8

    Time frame: Week 8

    Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <125 nmol/L. The percentage of participants with Lp(a) <125 nmol/L at week 8 will be reported.

  6. Percentage of Participants with Lp(a) <75 nmol/L at Week 8

    Time frame: Week 8

    Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <75 nmol/L. The percentage of participants with Lp(a) <75 nmol/L at week 8 will be reported.

  7. Percent Change from Baseline in Lp(a) at Week 12

    Time frame: Baseline and Week 12

    Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a).

  8. Percent Change from Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

    Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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