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A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
NCT07242469 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
About this study
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 criteria
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 design
Enrollment target: 52 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-22
Estimated completion: 2026-08-28
Last updated: 2026-01-14
Interventions
Drug: MK-1403 + additive coformulationDrug: Placebo + additive coformulation
Primary outcomes
- • Number of participants who experience one or more adverse events (AE) (Up to approximately 28 days)
- • Number of participants who discontinue study intervention due to adverse events (Up to approximately 14 days)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (4)
ProSciento Inc. ( Site 0001)Recruiting
Chula Vista, California, United States
QPS-MRA, LLC ( Site 0004)Recruiting
Miami, Florida, United States
Advanced Pharma CR, LLC ( Site 0003)Recruiting
Miami, Florida, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)Recruiting
Springfield, Missouri, United States