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, HIV, 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 a new medication, enlicitide, behaves in the body. Researchers are testing two forms of the medication—a standard tablet and a test version—to measure its presence in the body over time. They seek healthy individuals who do not smoke, have a body mass index (BMI) between 18 and 32, and have no history of certain diseases. Healthy individuals meeting these criteria may be suitable candidates for the study. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

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.

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

Research has shown that enlicitide is about as safe as a placebo, which is a non-active pill. In some studies, 64% of people taking enlicitide reported unwanted effects, compared to 62% of those taking a placebo. This suggests that the drug's safety is comparable to a placebo. However, about 10% of adults taking enlicitide experienced serious unwanted effects, similar to other treatments. These findings come from studies not specific to the current trial, but they provide a good indication of what might be expected. ^{1 2 3 4}

Why are researchers excited about this trial's treatments?

Enlicitide is unique because it's being developed for healthy individuals, setting it apart from treatments typically aimed at specific conditions. While standard treatments often aim to manage or treat diseases in affected individuals, enlicitide's focus on healthy subjects suggests a preventative or novel enhancement approach. Researchers are excited about enlicitide because it might introduce a groundbreaking paradigm in healthcare, potentially enhancing overall health or resilience in healthy individuals, which is a relatively unexplored area. This trial could pave the way for advancements in preventive medicine and wellness optimization.

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

Research has shown that enlicitide, an oral pill, effectively lowers LDL cholesterol, often referred to as "bad cholesterol." Studies have found that enlicitide can reduce LDL levels by up to 60%, comparable to some injectable treatments. In one study, 67.5% of patients experienced at least a 50% drop in their LDL cholesterol, reaching recommended levels for heart health. Enlicitide is also easy for most people to take, making it a promising option for those needing to lower their cholesterol. Participants in this trial will receive either a single oral dose of the enlicitide reference tablet or the enlicitide test tablet to evaluate its effects. ^{1 4 5 6 7}

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 who haven't smoked or used nicotine/tobacco products in the last 3 months. Participants should have a BMI between 18 and 32 kg/m^2.

Inclusion Criteria

Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

I haven't smoked or used nicotine products for at least 3 months.

Exclusion Criteria

I have a history of stomach or intestine problems that affect how I absorb food and medicine, or I've had surgery like a gastric bypass.

Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

I have had cancer before.

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 reference or test tablet

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Blood samples are collected to determine pharmacokinetic parameters of enlicitide

7 days

Multiple visits (in-person) for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide

Trial Overview The study aims to understand how different formulations of a medication called Enlicitide behave in the body over time by measuring its levels after administration.

How Is the Trial Designed?

Group I: Treatment B: enlicitide test tablet Experimental Treatment 1 Intervention

Participants receive a single oral dose of enlicitide test tablet.

Group II: Treatment A: enlicitide reference tablet Experimental Treatment 1 Intervention

Participants receive a single oral dose of enlicitide reference 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. merck.com merck.com/news/mercks-enlicitide-decanoate-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-phase-3-coralreef-lipids-trial/

Merck's Enlicitide Decanoate, an Investigational Oral ... The study also showed that 67.5% of patients treated with enlicitide achieved the rigorous prespecified goal of at least 50% reduction in LDL-C ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2841258

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, ...

3. newsroom.heart.org newsroom.heart.org/news/investigational-daily-pill-lowered-bad-cholesterol-as-much-as-injectables

Investigational daily pill lowered bad cholesterol as much ... The oral medication, enlicitide, lowered LDL cholesterol by up to 60% and could eventually offer an option for people whose LDL levels remain ...

4. statnews.com statnews.com/2025/11/08/merck-enlicitide-cholesterol-pill-study-results/

Merck's pill to reduce cholesterol on top of statins matches ... Merck's enlicitide pill lowered LDL cholesterol by up to 60%, matching injectables like Repatha and offering an easier option for patients.

5. tctmd.com tctmd.com/news/oral-pcsk9-inhibitor-enlicitide-cuts-ldl-cholesterol-coralreef-lipids

Oral PCSK9 Inhibitor Enlicitide Cuts LDL Cholesterol Two-thirds of enlicitide-treated patients had a more than 50% reduction in LDL cholesterol and achieved the recommended target of less than 55 ...

6. cnn.com cnn.com/2025/11/08/health/enlicitide-cholesterol-lowering-drug-study

Experimental daily pill may lower cholesterol in patients ... As for the safety of the drug, about 10% of the adults taking enlicitide experienced serious adverse events during the study and a similar share ...

7. ajmc.com ajmc.com/view/oral-pcsk9-inhibitor-enlicitide-matches-injectables-in-lowering-ldl-cholesterol

Oral PCSK9 Inhibitor Enlicitide Matches Injectables in ... The safety profile of enlicitide was comparable to placebo, with adverse events (AEs) occurring in 64% and 62% of patients, respectively, and ...