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Phase 2 study of MK-7262 and enlicitide decanoate in adults with high lipoprotein(a)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have Elevated lipoprotein(a), a blood protein that can increase the risk of heart disease. High levels of this protein, often called Lp(a), together with high LDL-C (the “bad” cholesterol) are linked to more plaque buildup in arteries.

The investigation tests a new oral medication called MK-7262 alone and in combination with a second oral agent, enlicitide decanoate. The goal is to see whether these medicines can lower the amount of the protein and the bad cholesterol more than a dummy pill (placebo).

Participants will take the assigned tablets once daily for several weeks, with regular check‑ins at the clinic to collect blood samples and report any side effects. The study lasts about two months, after which safety and how well the medicines worked are assessed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    You attend a first visit where the study staff confirm that you meet the eligibility criteria and collect blood samples to measure your current levels of lipoprotein(a) and ldl-c. after this assessment you are randomly assigned to receive either mk-7262, enlicitide decanoate, the combination of both, or a matching placebo. the study medication is provided in tablet form for oral use.

  2. Step 2

    Start study medication

    You begin taking the assigned tablet each day. the exact dose is not disclosed in the study information, but the tablet is taken by mouth once daily. you continue this dosing for the entire 12‑week treatment period.

  3. Step 3

    Daily dosing period

    Throughout weeks 1 to 12 you take the study tablet at the same time each day, preferably with water and without food restrictions unless instructed otherwise. you keep a record of each dose taken and report any side effects to the study staff.

  4. Step 4

    Week 4 safety check

    At the end of week 4 you return for a safety visit. blood is drawn again to monitor any changes in laboratory values and to check for possible adverse events (unwanted medical problems). the study staff ask about how you feel and whether you have experienced any new symptoms.

  5. Step 5

    Week 8 primary assessment

    At week 8 you attend a major study visit. blood samples are taken to determine the percent change from baseline in lipoprotein(a) and ldl-c. these measurements are the primary outcomes of the trial. the staff also review any adverse events you may have had and decide whether the medication should be continued.

  6. Step 6

    Week 12 final assessment

    At week 12 you complete the final study visit. additional blood tests evaluate the percent change from baseline in lipoprotein(a) and ldl-c at this later time point. a full safety review is performed, including documentation of any adverse events that occurred during the study.

  7. Step 7

    Study completion

    After the week 12 visit you stop taking the study medication. the study staff may discuss the overall results with you and provide information about any follow‑up that might be needed.

Who can join the trial?

3 criteria

  • You must have an elevated level of Lp(a) (a type of cholesterol particle) that is 150 nmol/L or higher.
  • You need to be taking a statin medication at an optimized and stable dose for at least 30 days, and you cannot plan to add, change, or stop the statin during the study.
  • You can be either male or female, and you must fall within the age range required by the study.

Who cannot join the trial?

9 criteria

  • Having a past diagnosis of homozygous familial hypercholesterolemia (a genetic condition that causes very high cholesterol), compound heterozygous FH, or double heterozygous FH.
  • Having a history of serious heart problems such as class IV heart failure (the most severe form of heart failure), severe ventricular systolic dysfunction (weak heart pumping), uncontrolled irregular heart rhythm (ventricular arrhythmia), a very long heart‑rate test result (prolonged corrected QT interval), untreated high blood pressure (hypertension), or a recent heart attack, stroke, or major blood‑vessel blockage and surgery (coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization).
  • Having a human immunodeficiency virus (HIV) infection that is not well‑controlled (i.e., viral load is detectable).
  • Having an active infection with hepatitis C virus or an active or chronic infection with hepatitis B virus (both are liver infections).
  • Having a past diagnosis of nephrotic syndrome (a kidney condition that causes large loss of protein in the urine).
  • Having severe kidney failure, known as severe renal insufficiency.
  • Having taken certain medicines or treatments within a restricted time period defined by the study protocol.
  • Having ongoing or long‑term liver or bile‑duct disease (hepatobiliary or hepatic disease).
  • Having poorly controlled Type 1 or Type 2 diabetes (blood‑sugar levels that are not kept within target ranges).
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Investigated drugs

  • MK-7262

    is an oral, film‑coated tablet that is being tested to see if it can lower the amount of “bad” cholesterol (LDL‑C) and a special protein called lipoprotein(a) that can increase heart risk. In the study, participants may take this medicine alone (monotherapy) or together with another drug. Researchers want to know how well it works by itself and whether it adds extra benefit when combined with the other medication.

  • MK-0616

    (which contains the active ingredient enlicitide decanoate) is an oral tablet that is also being studied for its ability to reduce lipoprotein(a) and LDL‑C. In the trial, it may be given by itself or together with MK‑7262. The goal is to find out how much this medicine alone can lower the target cholesterol levels and how it works when added to the other drug.

What is already known about the treatment

  • Enlicitide Decanoate

    This medication is taken by mouth as a tablet that you swallow. It is currently an investigational drug being studied in early‑stage clinical trials. It is being tested to lower high levels of lipoprotein(a) and LDL cholesterol, which are risk factors for heart disease. Enlicitide decanoate works by reducing the liver’s production of lipoprotein(a) and belongs to the class of lipid‑lowering agents.

  • MK-7262

    MK‑7262 is a film‑coated tablet taken orally. It is also an investigational product that is in Phase 2 clinical testing. The drug is aimed at reducing elevated lipoprotein(a) and LDL‑cholesterol to help prevent cardiovascular problems. MK‑7262 acts by blocking a protein that removes LDL receptors, allowing the body to clear more LDL‑C from the blood, and it is classified as a PCSK9‑inhibiting lipid‑lowering therapy.

Investigated diseases

Elevated lipoprotein(a) - Elevated lipoprotein(a) is a condition in which the blood contains higher than normal levels of the lipoprotein particle Lp(a). Lp(a) consists of an LDL‑like particle attached to a protein called apolipoprotein(a). Levels tend to remain stable over a person’s lifetime, and the concentration can increase modestly with age or certain hormonal changes. The condition may persist unless lifestyle or metabolic factors influence its level.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525102-38-00Protocol codeMK-7262-004Estimated enrolment750 patientsSponsorMerck Sharp & Dohme LLC

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