NCT07242469PHASE1Recruiting
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
Merck Sharp & Dohme LLC
Start Date
12/22/2025
Completion Date
9/3/2026
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 Criteria
Age Range: 18 years to 75 years
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
Interventions
DRUG
MK-1403 + additive coformulation
DRUG
Placebo + additive coformulation
Conditions
Diabetes Mellitus, Type 2
Locations
Anaheim Clinical Trials ( Site 0006)
Anaheim, California 92801
United States
ProSciento Inc. ( Site 0001)
Chula Vista, California 91911
United States
Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida 33147
United States
QPS-MRA, LLC ( Site 0004)
South Miami, Florida 33143
United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)
Springfield, Missouri 65802
United States