Enlicitide for Liver Disease

No longer recruiting at 1 trial location

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Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Statins

Disqualifiers: Gastrointestinal disease, Cancer, Alcohol use, 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 explores how a new medicine, enlicitide, behaves in the body, particularly its effects on cholesterol levels in individuals with liver issues. The researchers aim to compare the effects of enlicitide between those with liver problems and healthy individuals. Participants will receive a single dose to observe how the medicine moves through the body. Individuals with stable liver problems for more than six months who are otherwise generally healthy might be suitable for this trial. 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 medicine.

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

The trial requires that participants are not on statin therapy, so you would need to stop taking statins if you are currently using them.

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

Research has shown that enlicitide, a pill designed to lower bad cholesterol (LDL-C), has been promising in earlier studies. It achieved important goals in trials with adults who have high cholesterol, effectively lowering LDL-C levels in a clear and meaningful way.

Current safety information comes from early studies, which help ensure the treatment is safe and well-tolerated. Although specific safety details for enlicitide are limited, its progression to human trials suggests no major safety concerns have arisen so far, indicating good tolerability.

For those considering joining the trial, enlicitide has passed initial safety checks. However, since it is still being tested, participants should discuss any concerns with healthcare professionals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about enlicitide for liver disease because it offers a novel approach by using a new active ingredient specifically designed to target liver function more directly. Unlike current treatments, which often include medications like lactulose and rifaximin that primarily manage symptoms, enlicitide aims to address the underlying liver impairment. Additionally, enlicitide is delivered as a single oral dose, which could simplify treatment regimens and improve patient compliance. This innovative mechanism and delivery method could potentially lead to more effective and convenient liver disease management.

What evidence suggests that enlicitide might be an effective treatment for lowering LDL-C in liver disease?

Research has shown that enlicitide effectively lowers levels of low-density lipoprotein cholesterol (LDL-C) in the blood. One study found that enlicitide significantly reduced LDL-C, often called "bad cholesterol," which is promising for people with high cholesterol. Another study indicated that enlicitide could also lower lipoprotein(a) levels, which can lead to heart disease. These findings suggest that enlicitide might be a useful treatment for managing cholesterol-related issues. In this trial, participants with varying degrees of hepatic impairment, as well as healthy controls, will receive a single oral dose of enlicitide to further evaluate its effects. ^{1 2 3 4 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 adults with chronic and stable liver scarring who have not had severe episodes due to worsening liver function in the past 2 months. Participants should be non-smokers or moderate smokers, with a BMI between 18.0 and 40.0 kg/m2.

Inclusion Criteria

I have not smoked or have smoked 10 or fewer cigarettes daily for the last 3 months.

I have long-term, stable liver disease with cirrhosis.

I am in good health except for my liver condition.

Exclusion Criteria

I have not had any stomach or intestine diseases or surgeries that affect how I absorb food and medicine.

I have never had cancer before.

All participants must not consume greater than 3 servings of alcoholic beverages per day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of enlicitide on Day 1

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Participants are monitored for pharmacokinetic parameters such as AUC, Cmax, and Tmax over 168 hours post-dose

1 week

Multiple visits (in-person and/or virtual) for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide

Trial Overview The study tests enlicitide decanoate's effects on lowering 'bad' cholesterol (LDL-C) levels in people with impaired liver function compared to healthy individuals. It examines how the body processes the drug over time.

How Is the Trial Designed?

Group I: Moderate Hepatic Impairment (HI) Experimental Treatment 1 Intervention

Participants will receive a single oral dose of enlicitide on Day 1

Group II: Mild HI Experimental Treatment 1 Intervention

Participants will receive a single oral dose of enlicitide on Day 1

Group III: Healthy Controls Experimental Treatment 1 Intervention

Participants will receive a single oral dose of enlicitide on Day 1

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/NCT06575959

NCT06575959 | A Clinical Study of Enlicitide Decanoate in ... Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11722601/

Emerging oral therapeutic strategies for inhibiting PCSK9 Among the exploratory endpoints, enlicitide decanoate demonstrated to reduce the Lp(a) plasma levels at week 8 by −12.2 % (6 mg), −21.3 % (12 ...

3. sigma.larvol.com sigma.larvol.com/moa.php?e1=13039&e2=&sourcepg=TZMoa&tab=OTTtrac&sr=now&er=1+month&ipwnd=on&rlink=,tab=OTTtrac,sourcepg=TZMoa,itype=0,1&rflag=1&page=3

PCSK9 inhib Trials NCT06691906: A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025). Completed. 1 ; MK-0616-026, NCT06772779: A Study of ...

4. 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 ... Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL ...

5. clinicaltrials.eu clinicaltrials.eu/inn/enlicitide-chloride/

Enlicitide Chloride – Application in Therapy and Current ... This article examines the ongoing research into this promising drug, focusing on its safety, tolerability, and effectiveness in various patient populations. We' ...

6. trial.medpath.com trial.medpath.com/clinical-trial/a3cf79079566e0db/nct06719544-clinical-study-enlicitide-lithium-pharmacokinetics

A Study of Lithium and Enlicitide in Healthy Adult Participants ... Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol ...