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

August 13, 2026 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials ( Site 0006)
      • Chula Vista, California, United States, 91911
        • ProSciento Inc. ( Site 0001)
    • Florida
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC ( Site 0003)
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC ( Site 0004)
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A MK-1403 + additive coformulation dose 1
Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
Drug: MK-1403 + additive coformulation
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo Comparator: Panel A Placebo + additive coformulation dose 1
Participants will receive Placebo + additive coformulation dose 1 orally once daily.
Drug: Placebo + additive coformulation
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Experimental: Panel B MK-1403 + additive coformulation dose 2
Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
Drug: MK-1403 + additive coformulation
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo Comparator: Panel B Placebo + additive coformulation dose 2
Participants will receive Placebo + additive coformulation dose 2 orally once daily
Drug: Placebo + additive coformulation
Placebo + additive coformulation is a co-formulated product of placebo administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience one or more adverse events (AE)
Time Frame: Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Up to approximately 28 days
Number of participants who discontinue study intervention due to adverse events
Time Frame: Up to approximately 14 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Time Frame: Baseline and 24-hours postdose on Day 14
Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP.
Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
Time Frame: 24-hour postdose on Day 14
Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14.
24-hour postdose on Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

September 3, 2026

Study Completion (Estimated)

September 3, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1403-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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