Enlicitide for Healthy Subjects

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Gastrointestinal disease, Cancer, Hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: 169

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests enlicitide to observe its behavior in healthy individuals when taken on an empty stomach or after eating. Researchers aim to understand how food affects enlicitide absorption in the body. Participants will be divided into groups to take a single oral dose at various times after a meal or after fasting. Ideal participants are healthy individuals with a body mass index (BMI) between 18 and 32, without conditions affecting food absorption, such as gastrointestinal disease or lactose intolerance. As a Phase 1 trial, this research focuses on understanding enlicitide's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that enlicitide is likely to be safe for humans?

Research has shown that enlicitide is usually well-tolerated. Enlicitide, a pill that helps lower cholesterol, has a good safety record according to studies. For example, one study with adults who have high cholesterol found that enlicitide was generally safe at different doses, meaning it doesn't cause serious side effects for most people. However, this trial involves healthy individuals, not those with high cholesterol. While past studies show positive safety results, the experience might differ in this research. Consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Enlicitide is unique because it offers a new approach to drug delivery by testing different timing strategies for its oral administration. Unlike standard treatments that may require consistent timing relative to meals, Enlicitide is being investigated for its flexibility and potential to optimize absorption based on meal timing. Researchers are particularly excited about its potential to improve drug efficacy and convenience for patients by adjusting the administration window to enhance the body's uptake of the medication.

What evidence suggests that enlicitide could be effective?

Research has shown that enlicitide, a pill that helps lower cholesterol, can significantly reduce levels of "bad" cholesterol (LDL-C). One study demonstrated that participants experienced up to a 60.9% drop in LDL-C after 8 weeks of taking enlicitide compared to those on a placebo. This result is promising for individuals needing to manage high cholesterol. The treatment has also been studied for its ability to reduce serious heart-related problems in high-risk patients, highlighting its potential benefits. These findings suggest that enlicitide may effectively lower cholesterol and improve heart health. In this trial, participants will receive a single oral dose of enlicitide under different conditions to further evaluate its effects. ^{1 2 6 7 8}

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 a BMI between 18 and 32. It's designed to understand how the body processes enlicitide, a drug, when taken with or without food.

Inclusion Criteria

My BMI is between 18 and 32.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of enlicitide under different fasting conditions

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Participants are monitored for pharmacokinetic parameters of enlicitide in plasma

1 week

Multiple time points up to 168 hours post-dose

Follow-up

Participants are monitored for safety and adverse events

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide

Trial Overview

The study tests the effects of enlicitide on healthy individuals. Participants will take enlicitide either on an empty stomach or with food to see if there are any differences in how their bodies handle the drug.

How Is the Trial Designed?

Group I: Enlicitide Treatment D Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 2 hours after morning meal.

Group II: Enlicitide Treatment C Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 3 hours after morning meal.

Group III: Enlicitide Treatment B Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide 4 hours after morning meal.

Group IV: Enlicitide Treatment A Experimental Treatment 1 Intervention

Participants receive single oral dose of enlicitide after 8-hour overnight fast.

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

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jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2841258

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

A phase 2, placebo-controlled, randomized clinical trial demonstrated that 8 weeks of treatment with enlicitide resulted in up to a 60.9% ...

2.

merck.com

merck.com/news/mercks-investigational-oral-pcsk9-inhibitor-enlicitide-decanoate-met-all-primary-and-key-secondary-endpoints-in-adults-with-hypercholesterolemia-in-pivotal-coralreef-lipids-study/

Merck's Investigational Oral PCSK9 Inhibitor Enlicitide ...

The study's primary objective was to assess whether enlicitide decanoate was superior to placebo in reducing LDL-C, as measured by mean percent ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06008756

NCT06008756 | Enlicitide Decanoate (MK-0616 Oral ...

This phase 3 study evaluates enlicitide decanoate, an oral PCSK9 inhibitor, against placebo to reduce major adverse cardiovascular events in high-risk ...

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msdclinicaltrials.com

msdclinicaltrials.com/trial/nct06008756/

MK-0616 Cardiovascular Outcomes Study - MSD Clinical Trials

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type ...

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clinicaltrial.be

clinicaltrial.be/en/details/278223?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 ...

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07058077

NCT07058077 | A Study of Enlicitide Decanoate (MK-0616 ...

This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial ...

7.

msd.com

msd.com/news/msds-mk-0616-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-patients-with-hypercholesterolemia-in-phase-2b-study/

MSD's MK-0616, an Investigational Oral PCSK9 Inhibitor ...

MK-0616 was generally well-tolerated at all 4 doses studied. These data were presented today at the American College of Cardiology's 72nd Annual ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05261126

A Study of the Efficacy and Safety of Enclitide Chloride (MK ...

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein ...