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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-01-02

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Enlicitide Chloride

Intervention Type BIOLOGICAL

Oral administration

Placebo

Participants receive placebo orally for up to approximately 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral administration

Interventions

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Enlicitide Chloride

Oral administration

Intervention Type BIOLOGICAL

Placebo

Oral administration

Intervention Type OTHER

Other Intervention Names

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MK-0616

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes