Enlicitide for Liver Disease

Recruiting at 1 trial location

Overseen By Toll Free Number

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

40 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). 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) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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