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
1 other identifier
interventional
52
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus-type-2
Started Dec 2025
Typical duration for phase_1 diabetes-mellitus-type-2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 28, 2026
January 14, 2026
January 1, 2026
8 months
November 17, 2025
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants who experience one or more adverse events (AE)
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
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 Outcomes (2)
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
24-hour postdose on Day 14
Study Arms (4)
Panel A MK-1403 + additive coformulation dose 1
EXPERIMENTALParticipants will receive MK-1403 + additive coformulation dose 1 orally once daily.
Panel A Placebo + additive coformulation dose 1
PLACEBO COMPARATORParticipants will receive Placebo + additive coformulation dose 1 orally once daily.
Panel B MK-1403 + additive coformulation dose 2
EXPERIMENTALParticipants will receive MK-1403 + additive coformulation dose 2 orally once daily
Panel B Placebo + additive coformulation dose 2
PLACEBO COMPARATORParticipants will receive Placebo + additive coformulation dose 2 orally once daily
Interventions
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Eligibility Criteria
You may qualify if:
- Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
ProSciento Inc. ( Site 0001)
Chula Vista, California, 91911, United States
QPS-MRA, LLC ( Site 0004)
Miami, Florida, 33143, United States
Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida, 33147, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)
Springfield, Missouri, 65802, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 21, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
August 28, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf