Enlicitide for Kidney Failure

Recruiting at 4 trial locations

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Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Statins

Must not be taking: Transplant medications

Disqualifiers: Renal artery stenosis, GI disease, others

No Placebo Group

Trial Summary

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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of statin therapy for at least 2 months, so you will not need to stop taking your statin medication. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with severe kidney problems (renal impairment) and healthy individuals, both having a BMI between 18 and 40. Participants must have been on a stable statin therapy dose for at least two months without changes.

Inclusion Criteria

My BMI is between 18 and 40.

I have been on the same statin dose for at least 2 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enlicitide once daily for 28 days

4 weeks

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1-2 visits (in-person)

Treatment Details

Interventions

• Enlicitide (Other)

Trial Overview The study tests enlicitide, a new medication intended to lower 'bad' cholesterol (LDL-C). It will compare how the drug behaves in the body over time between those with severe kidney issues and healthy people.

Participant Groups

Group I: Panel B: Healthy Experimental Treatment 1 Intervention

Healthy participants receive enlicitide QD for 28 days.

Group II: Panel A: Severe Renal Impairment Experimental Treatment 1 Intervention

Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.

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