Enlicitide for Kidney Failure

No longer recruiting at 5 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine called enlicitide to determine its effects on the body, specifically in lowering bad cholesterol (LDL-C) levels. Researchers aim to understand how enlicitide behaves in individuals with severe kidney problems compared to healthy individuals. Those with long-standing kidney issues who are on a stable dose of statins (medications used to lower cholesterol) might be suitable for this study. Participants will take the medicine daily for 28 days. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new medicine.

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.

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

A previous study found that enlicitide was generally well-tolerated by people with moderate kidney problems, with most not experiencing serious side effects. Researchers are now examining how enlicitide affects individuals with severe kidney issues compared to those with healthy kidneys. As this is an early-stage study, the primary goal is to understand the body's processing of the medicine and its safety. Detailed safety information may be limited, as this is the first time the treatment is tested in people with severe kidney problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Enlicitide is unique because it offers a novel approach to treating kidney failure. Most treatments for this condition focus on managing symptoms and slowing disease progression, often involving dialysis or kidney transplantation. However, enlicitide works differently by potentially enhancing kidney function at the cellular level, which could lead to improved outcomes without the need for invasive procedures. Researchers are excited about its potential to change the treatment landscape by providing a less invasive option with promising results in just a few weeks. This could be a game-changer for patients with severe renal impairment and those looking to prevent kidney issues through early intervention.

What evidence suggests that enlicitide might be an effective treatment for kidney failure?

Studies have shown that enlicitide, a new oral medication being tested, can significantly lower LDL-C, or bad cholesterol levels. Research indicates that enlicitide blocks a protein that usually keeps cholesterol levels high. In earlier studies, participants found the treatment easy to follow, and it was well tolerated. This trial will evaluate enlicitide in two groups: participants with severe renal impairment and healthy participants, both receiving the treatment once daily for 28 days. The treatment's ability to lower LDL-C is promising, suggesting it could help people with high cholesterol, including those with severe kidney problems. Although more research is needed, these findings support enlicitide's potential for managing cholesterol levels. ^{2 3 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 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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Enlicitide

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05934292?intr=MK-0616&rank=10

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor ... The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05070390

NCT05070390 | A Study of Enlicitide Chloride (MK-0616 ... This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to ...

3. ctv.veeva.com ctv.veeva.com/study/mk-0616-oral-pcsk9-inhibitor-renal-impairment-study-2-mk0616020

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal ... The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in ...

4. 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 ... High adherence with study intervention (97%) and dosing instructions (≥97%) were observed across treatment groups. “Enlicitide demonstrated ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06643377/a-clinical-study-of-enlicitide-in-participants-with-severe-renal-impairment-mk-0616-032

A Clinical Study of Enlicitide in Participants With Severe ... Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05070390

NCT05070390 | A Study of Enlicitide Chloride (MK-0616 ... This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to ...

7. withpower.com withpower.com/trial/enlicitide-for-kidney-failure-1644e

Enlicitide for Kidney Failure · Info for Participants This Phase 1 medical study run by Merck Sharp & Dohme LLC needs participants to evaluate whether Enlicitide will have tolerable side effects & efficacy for ...