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A Study of Enlicitide and Rosuvastatin for Adults With High Cholesterol

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What is this trial about?

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

This study involves people with hyperlipidemia, which is a condition where there are high levels of fats, including cholesterol, in the blood. The study will test a medication called MK-0616, which contains the active substance enlicitide chloride, given together with another medication called rosuvastatin. Rosuvastatin is a medicine that helps lower cholesterol levels and is already used in medical practice. Some participants will receive the actual medications while others will receive placebo, which is an inactive treatment that looks like the real medication but contains no active medicine.

The purpose of the study is to compare how well enlicitide combined with rosuvastatin works compared to placebo in lowering cholesterol levels, specifically a type of cholesterol called low-density lipoprotein cholesterol, in the blood after eight weeks of treatment. The study will also look at the safety of this combination of medications by monitoring any unwanted effects that may occur during the treatment period.

Participants in this study will take the study medications by mouth in the form of film-coated tablets for up to twelve months. During the study, measurements will be taken at different time points, particularly at week eight and week twelve, to see how the cholesterol levels change from the beginning of the study. The study will also measure other types of fats in the blood and count how many participants reach certain target cholesterol levels. The study is expected to start enrolling participants in late 2025 and continue until early 2027.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    Upon joining the study, you will be randomly assigned to one of the treatment groups. This means that neither you nor your doctor will choose which treatment you receive.

    You will receive either enlicitide combined with rosuvastatin, or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredients.

    Both medications will be taken orally, meaning you will swallow them by mouth.

    The medications come in the form of film-coated tablets.

  2. Step 2

    Week 8 assessment

    At Week 8 of the study, your cholesterol levels will be measured.

    Specifically, your LDL cholesterol will be tested. LDL cholesterol is often called bad cholesterol because high levels can increase the risk of heart disease.

    Other cholesterol-related measurements will also be taken, including Apolipoprotein B, non-HDL cholesterol, and Lipoprotein (a).

    Your doctor will check for any side effects or unwanted reactions you may have experienced since starting the treatment.

  3. Step 3

    Week 12 assessment

    At Week 12 of the study, another measurement of your LDL cholesterol will be taken.

    Your doctor will continue to monitor for any side effects or adverse events throughout this period.

  4. Step 4

    Ongoing monitoring

    Throughout the study, your doctor will record any adverse events. These are any unwanted medical occurrences that happen while you are taking the study medication.

    If you experience side effects that are concerning, your participation in the study may be discontinued for your safety.

Who can join the trial?

4 criteria

  • You must be between 18 and 64 years old
  • You can be of any sex or gender
  • You must either not be taking any cholesterol-lowering medicines, or you must not have taken certain cholesterol-lowering medicines for a specific amount of time before joining the study
  • You must have hyperlipidemia, which means you have high levels of fats in your blood, such as cholesterol

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the provided information.
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Investigated drugs

  • Enlicitide Decanoate

    is an investigational medication being studied in this trial. It is given together with rosuvastatin to see if the combination can help lower cholesterol levels in adults with high cholesterol.

  • Rosuvastatin

    is a medication commonly used to lower cholesterol levels in the blood. It belongs to a group of medicines called statins, which work by reducing the amount of cholesterol made by the liver. In this study, it is being given together with enlicitide decanoate.

What is already known about the treatment

  • Enlicitide Decanoate

    This medication is given as an injection and is currently being studied in Phase 3 clinical trials to evaluate its effectiveness and safety. It is being tested in combination with rosuvastatin for treating hyperlipidemia, a condition where there are high levels of fats in the blood. Enlicitide works at the molecular level to help lower LDL cholesterol (often called "bad cholesterol") in the bloodstream, and it belongs to a class of drugs designed to manage lipid disorders and reduce cardiovascular risk.

  • Rosuvastatin

    This medication is taken by mouth, usually as a tablet, and is an established treatment widely used in medical practice for managing high cholesterol levels. It is prescribed for hyperlipidemia and works by blocking an enzyme in the liver that produces cholesterol, thereby reducing the amount of LDL cholesterol and other harmful fats in the blood. Rosuvastatin belongs to a class of medications called statins, which are among the most commonly prescribed drugs for preventing heart disease and stroke.

Investigated diseases

Hyperlipidemia – Hyperlipidemia is a condition characterized by abnormally high levels of fats in the blood, including cholesterol and triglycerides. These fats, also called lipids, can build up in the bloodstream when the body produces too much of them or cannot process them efficiently. The condition often develops gradually over time without causing noticeable symptoms in its early stages. As lipid levels remain elevated, fatty deposits may begin to accumulate in blood vessel walls. This accumulation can lead to narrowing and hardening of the arteries throughout the body. Hyperlipidemia can be influenced by genetic factors, diet, physical activity levels, and other health conditions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521495-54-00Protocol codeMK-0616-037Estimated enrolment975 patientsSponsorMerck Sharp & Dohme LLC

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