Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
MK-2828
Placebo
Clinical Study ID
Ages 24-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 bodyweight for at least 3 months before Visit 1/Screening
T2DM treated with lifestyle modification alone or with stable doses (no significantchange for ≥3 months from Visit 1/Screening, based on self-reporting) of ≤ 3 oralanti-diabetic medications and anticipated not to require dose adjustments during thestudy duration
Body mass index (BMI) between 25 and 40 kg/m2, inclusive
Exclusion
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 othernucleotide-binding, leucine-rich, protein 3 inhibitor (NLRP3i) based therapy, itsinactive ingredients, or the placebo
Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3or 4)
Has a history of myocardial infarction, uncontrolled arrhythmias, cardiacrevascularization, unstable peripheral arterial disease and/or stroke within 6months of screening
History of significant multiple and/or severe allergies (e.g., food, drug, latexallergy), 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 diabeticretinopathy, or maculopathy
Has previous or planned (during the trial period) obesity treatment with surgery ora weight loss device
Study Design
Connect with a study center
ProSciento Inc. ( Site 0004)
Chula Vista, California 91911
United StatesSite Not Available
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)
Glendale, California 91206
United StatesSite Not Available
Velocity Clinical Research, Hallandale Beach ( Site 0010)
Hallandale, Florida 33009
United StatesSite Not Available
Jacksonville Center for Clinical Research ( Site 0002)
Jacksonville, Florida 32216
United StatesSite Not Available
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida 33147
United StatesSite Not Available
QPS Miami Research Associates ( Site 0005)
South Miami, Florida 33143
United StatesSite Not Available
AMR Lexington ( Site 0012)
Lexington, Kentucky 40509
United StatesSite Not Available
Alliance for Multispecialty Research, LLC ( Site 0013)
Kansas City, Missouri 64114
United StatesSite Not Available
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)
Springfield, Missouri 65802
United StatesSite Not Available
AMR Clinical ( Site 0003)
Knoxville, Tennessee 37920
United StatesSite Not Available
ICON Early Phase Services ( Site 0006)
San Antonio, Texas 78209
United StatesSite Not Available

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