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

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Diabetes Mellitus, Type 2

Interventions: MK-2828, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 24 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (11)

Chula Vista, California, United States
Glendale, California, United States
Hallandale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
Lexington, Kentucky, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States