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

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called MK-1403 to see if it can safely and effectively improve blood sugar control in people with Type 2 diabetes. The trial will evaluate the drug's safety, side effects, and how well it works. **You may be eligible if...** - You have been confirmed to have Type 2 diabetes - Your body mass index (BMI) is between 18 and 40 kg/m² **You may NOT be eligible if...** - You have Type 1 diabetes or another specific subtype of diabetes - You have a history of severe heart failure (NYHA Class 3 or 4) - You have had a heart attack, stroke, unstable chest pain, or major heart or vascular procedure - You have a history of cancer - You have hepatitis B, hepatitis C, or HIV - You have a digestive condition that affects how you absorb food or medication, or have had gastric bypass surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Advanced Pharma CR, LLC ( Site 0003)

Miami, Florida, United States

QPS-MRA, LLC ( Site 0004)

South Miami, Florida, United States

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

Springfield, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT07242469


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