Enlicitide + Rosuvastatin for Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Prescription drugs, Herbal remedies

Disqualifiers: Female childbearing potential, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how two medicines, enlicitide and rosuvastatin, work in healthy individuals. Researchers seek to measure the concentration of each medicine in the body over time, both when taken separately and when combined into one tablet. It suits healthy non-smokers who haven't used nicotine for at least three months and don't take any medications or supplements. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enlicitide, whether used alone or with rosuvastatin, is generally safe. Studies have found that enlicitide significantly lowers cholesterol levels and is well-tolerated by most individuals. Rosuvastatin, a common treatment for reducing bad cholesterol, is also known for its safety. When combined, enlicitide and rosuvastatin have been tested in individuals with high cholesterol and have shown to be safe. So far, no major safety concerns have emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of enlicitide and rosuvastatin because enlicitide is a novel compound that may enhance the cholesterol-lowering effects of rosuvastatin. Unlike existing treatments that primarily focus on inhibiting cholesterol synthesis, enlicitide has the potential to offer a new mechanism by improving the way cholesterol is processed in the body. Additionally, the single-dose administration of MK-0616A offers a streamlined approach to managing cholesterol, potentially making treatment more convenient. This could mean more effective and convenient options for controlling cholesterol levels in the future.

What evidence suggests that this trial's treatments could be effective?

Research shows that enlicitide and rosuvastatin effectively lower "bad" cholesterol, known as LDL-C. Studies have found that enlicitide is safe and significantly reduces LDL-C levels in adults with high cholesterol. Rosuvastatin, a well-known medication, lowers cholesterol by blocking a substance the body needs to produce it. In this trial, participants will receive either a combination of enlicitide and rosuvastatin or a single dose of MK-0616A. Early evidence suggests that combining enlicitide and rosuvastatin may control cholesterol better than using each one alone. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults with no significant medical history, who haven't smoked or used nicotine/tobacco products in the last 3 months. It's designed to understand how two medicines, enlicitide and rosuvastatin, behave in the body alone and combined.

Inclusion Criteria

I am generally healthy with no major medical issues.

I have not smoked or used nicotine products for at least 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of enlicitide and rosuvastatin, either separately or combined

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Blood samples are collected to determine pharmacokinetic parameters of enlicitide and rosuvastatin

168 hours

Multiple visits (in-person) for blood sampling

Follow-up

Participants are monitored for adverse events and safety

Up to approximately 9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide and Rosuvastatin

Trial Overview

The study tests enlicitide and rosuvastatin, both separately and combined into one tablet. Researchers will monitor how these drugs are processed over time within participants' bodies to assess their interaction.

How Is the Trial Designed?

Group I: MK-0616A Experimental Treatment 1 Intervention

Participants will receive a single dose of MK-0616A

Group II: Enclidite + Rosuvastatin Experimental Treatment 2 Interventions

Participants will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07300280

A Clinical Trial of Enlicitide and Rosuvastatin in Healthy ...

Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07216482

NCT07216482 | A Clinical Study of Enlicitide in ...

The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like ...

3.

patlynk.com

patlynk.com/trial/NCT07216482

Enlicitide Decanoate and Rosuvastatin for Hyperlipidemia ...

Study AimThis clinical trial aims to test if Enlicitide Decanoate combined with Rosuvastatin is effective in treating high cholesterol levels (hyperlipidemia) ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41206969/

Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in ...

Conclusions: Among adults with HeFH, treatment with enlicitide was well tolerated and significantly reduced levels of LDL-C, apolipoprotein B, ...

5.

withpower.com

withpower.com/trial/phase-3-hyperlipidemias-10-2025-fb58b

Enlicitide + Rosuvastatin for High Cholesterol

Studies have found that enlicitide significantly lowers bad cholesterol (LDL-C) and is well tolerated by adults with high cholesterol.

6.

clinicaltrials.eu

clinicaltrials.eu/trial/a-study-of-enlicitide-and-rosuvastatin-for-adults-with-high-cholesterol/

A Study of Enlicitide and Rosuvastatin for Adults With High ...

The purpose of the study is to compare how well enlicitide combined with rosuvastatin works compared to placebo in lowering cholesterol levels, ...