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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06655311
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Enlicitide Chloride — BIOLOGICAL
    Oral administration
  • Placebo — OTHER
    Oral administration

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Oct 2024
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Placebo
    Participants receive placebo orally for up to approximately 6 weeks.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 56 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Kansas, Inc. (Site 0002)Overland ParkKansas66212-

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Altasciences Clinical Kansas, Inc.· Overland Park, KS

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