A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)

NCT ID: NCT06772779

Last Updated: 2025-01-15

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-06-04

Brief Summary

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The main goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.

Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Warfarin Plus Enlicitide Decanoate

Participants receive oral warfarin and oral enlicitide decanoate.

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

single oral dose

Enlicitide Decanoate

Intervention Type DRUG

single oral dose

Lisinopril Plus Enlicitide Decanoate

Participants receive oral lisinopril and oral enlicitide decanoate.

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

single oral dose

Lisinopril

Intervention Type DRUG

single oral dose

Interventions

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Warfarin

single oral dose

Intervention Type DRUG

Enlicitide Decanoate

single oral dose

Intervention Type DRUG

Lisinopril

single oral dose

Intervention Type DRUG

Other Intervention Names

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Jantoven MK-0616 Zestril

Eligibility Criteria

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Inclusion Criteria

* Is in good health
* Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2

Exclusion Criteria

* History of gastrointestinal disease which may affect food or drug absorption, or has had a gastric bypass or similar surgery
* History of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Celerion (Site 0001)

Tempe, Arizona, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-0616-026

Identifier Type: OTHER

Identifier Source: secondary_id

0616-026

Identifier Type: -

Identifier Source: org_study_id

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