RecruitingPhase 1NCT07242469

A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)

A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus


Sponsor

Merck Sharp & Dohme LLC

Enrollment

52 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
  • Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive

Exclusion Criteria6

  • Has Type 1 diabetes mellitus or secondary types of diabetes
  • Has a history of congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4)
  • Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
  • Has history of cancer (malignancy)
  • Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
  • Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery

Interventions

DRUGMK-1403 + additive coformulation

MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.

DRUGPlacebo + additive coformulation

Placebo + additive coformulation is a co-formulated product of placebo administered orally.


Locations(4)

ProSciento Inc. ( Site 0001)

Chula Vista, California, United States

QPS-MRA, LLC ( Site 0004)

Miami, Florida, United States

Advanced Pharma CR, LLC ( Site 0003)

Miami, Florida, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)

Springfield, Missouri, United States

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NCT07242469


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