A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

Last updated: March 17, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Focal Segmental Glomerulosclerosis

Kidney Disease

Kidney Failure (Pediatric)

Treatment

Enlicitide

Clinical Study ID

NCT06643377
0616-032
MK-0616-032
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Body Mass Index (BMI) between 18 and 40 kg/m^2, inclusive

  • On a stable dose of statin therapy; no changes to dose or type of statin therapy forat least 2 months

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History or presence of renal artery stenosis

  • Had a functioning renal transplant in the past 5 years and is taking transplantmedication

  • History of gastrointestinal (GI) disease which might affect food and drug absorption

Panel A: Participants with Severe Renal Impairment:

  • History of any illness, other than hypercholesterolemia and Renal Impairment

Panel B: Healthy Participants:

  • History of clinically significant endocrine, GI, cardiovascular, hematological,hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other thanhypercholesterolemia

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Enlicitide
Phase: 1
Study Start date:
November 22, 2024
Estimated Completion Date:
May 22, 2025

Connect with a study center

  • Velocity Clinical Research, New Smyrna Beach ( Site 0003)

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Velocity Clinical Research, Hallandale Beach ( Site 0006)

    Hallandale Beach, Florida 33009
    United States

    Active - Recruiting

  • Nature Coast Clinical Research - Inverness ( Site 0002)

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research ( Site 0004)

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Genesis Clinical Research, LLC ( Site 0001)

    Tampa, Florida 33603
    United States

    Active - Recruiting

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