COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment

Quick Facts

Study Start:2024-11-22
Study Completion:2025-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06643377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body Mass Index (BMI) between 18 and 40 kg/m\^2, inclusive
  2. * On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months
  1. * History or presence of renal artery stenosis
  2. * Had a functioning renal transplant in the past 5 years and is taking transplant medication
  3. * History of gastrointestinal (GI) disease which might affect food and drug absorption

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)
Edgewater, Florida, 32132
United States
Velocity Clinical Research, Hallandale Beach ( Site 0006)
Hallandale Beach, Florida, 33009
United States
Nature Coast Clinical Research - Inverness ( Site 0002)
Inverness, Florida, 34452
United States
Jacksonville Center for Clinical Research ( Site 0004)
Jacksonville, Florida, 32216
United States
Genesis Clinical Research, LLC ( Site 0001)
Tampa, Florida, 33603
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22
Study Completion Date2025-06-25

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2025-06-25

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy
  • Renal Impairment