Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)

Summary

The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-2828. The study will also measure what happens to MK-2828 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

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* With the exception of type 2 diabetes mellitus (T2DM), is in generally good health
* Has a history of T2DM for ≥1 year at the time of screening based on self-reporting
* Has a baseline HbA1C level of ≤10% at the time of screening
* Has a stable weight (based on self-reporting) defined as ≤5 kg gain or loss of body weight for at least 3 months before Visit 1/Screening
* T2DM treated with lifestyle modification alone or with stable doses (no significant change for ≥3 months from Visit 1/Screening, based on self-reporting) of ≤ 3 oral anti-diabetic medications and anticipated not to require dose adjustments during the study duration
* Body mass index (BMI) between 25 and 40 kg/m2, inclusive

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has known systemic hypersensitivity to the MK-2828 drug substance or other nucleotide-binding, leucine-rich, protein 3 inhibitor (NLRP3i) based therapy, its inactive ingredients, or the placebo
* Has a history of congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4)
* Has a history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, unstable peripheral arterial disease and/or stroke within 6 months of screening
* History of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food
* Has type 1 diabetes mellitus or secondary types of diabetes
* Has experienced complications of diabetes such as ketoacidosis, unstable diabetic retinopathy, or maculopathy
* Has previous or planned (during the trial period) obesity treatment with surgery or a weight loss device

Conditions2

Locations11 sites

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