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Completed

NCT Number: NCT06655311

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

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.

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Key information

Conditions

Healthy Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Kansas, Inc. (Site 0002)

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enlicitide Chloride

Biological

Oral administration

Other names: MK-0616

Placebo

Other

Oral administration

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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