A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)

October 21, 2024 updated by: Merck Sharp & Dohme LLC

Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins

The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Altasciences Clinical Kansas, Inc. (Site 0002)

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

  • Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
  • Has a body mass index (BMI)≥18 and ≤32 kg/m^2

Exclusion Criteria:

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

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enlicitide Chloride
Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks.
Biological: Enlicitide Chloride
Oral administration
Other Names:
  • MK-0616
Placebo Comparator: Placebo
Participants receive placebo orally for up to approximately 6 weeks.
Other: Placebo
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 56 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Up to approximately 56 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 42 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Time Frame: At designated timepoints (up to approximately 24 hours)
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride.
At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Time Frame: At designated timepoints (up to approximately 1 week)
Blood samples will be collected to determine the Cmax of enlicitide chloride.
At designated timepoints (up to approximately 1 week)
Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride
Time Frame: At designated timepoints (up to approximately 1 week)
Blood samples will be collected to determine the C24 of enlicitide chloride.
At designated timepoints (up to approximately 1 week)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Time Frame: At designated timepoints (up to approximately 1 week)
Blood samples will be collected to determine the Tmax of enlicitide chloride.
At designated timepoints (up to approximately 1 week)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride
Time Frame: At designated timepoints (up to approximately 1 week)
Blood samples will be collected to determine the AUC0-Last of enlicitide chloride.
At designated timepoints (up to approximately 1 week)
Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride
Time Frame: Baseline, Week 1
Blood samples will be collected to determine the LDL-C of enlicitide chloride.
Baseline, Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

January 2, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-012
  • MK-0616-012 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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