A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMerck Sharp & Dohme LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
Has body mass index (BMI) between 18 and 40 kg/m², inclusive
Disqualifiers
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)
Trial design
Design model
Sequential
Treatments tested in this trial
MK-1403 + additive coformulation
DrugMK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo + additive coformulation
DrugPlacebo + additive coformulation is a co-formulated product of placebo administered orally.
Treatment groups
52 Participants
are divided into 4 treatment groupsGroup A: Panel A MK-1403 + additive coformulation dose 1Experimental treatment 1 intervention
Group B: Panel A Placebo + additive coformulation dose 1Placebo comparator 1 intervention
Group C: Panel B MK-1403 + additive coformulation dose 2Experimental treatment 1 intervention
Group D: Panel B Placebo + additive coformulation dose 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 28 days2
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.
Time frame
Up to approximately 14 daysSecondary outcomes
1
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP.
Time frame
Baseline and 24-hours postdose on Day 142
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14.
Time frame
24-hour postdose on Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov