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

Last updated: April 24, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

1

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

MK-2828

Placebo

Clinical Study ID

NCT07089784
2828-003
  • Ages 24-75
  • All Genders

Study 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 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

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: MK-2828
Phase: 1
Study Start date:
September 22, 2025
Estimated Completion Date:
May 06, 2026

Connect with a study center

  • ProSciento Inc. ( Site 0004)

    Chula Vista, California 91911
    United States

    Site Not Available

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

    Glendale, California 91206
    United States

    Site Not Available

  • ProSciento Inc. ( Site 0004)

    Chula Vista 5336899, California 5332921 91911
    United States

    Site Not Available

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

    Glendale 5352423, California 5332921 91206
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach ( Site 0010)

    Hallandale, Florida 33009
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research ( Site 0002)

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Advanced Pharma CR, LLC ( Site 0001)

    Miami, Florida 33147
    United States

    Site Not Available

  • QPS Miami Research Associates ( Site 0005)

    South Miami, Florida 33143
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach ( Site 0010)

    Hallandale 4157898, Florida 4155751 33009
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research ( Site 0002)

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Advanced Pharma CR, LLC ( Site 0001)

    Miami 4164138, Florida 4155751 33147
    United States

    Site Not Available

  • QPS Miami Research Associates ( Site 0005)

    South Miami 4173495, Florida 4155751 33143
    United States

    Site Not Available

  • AMR Lexington ( Site 0012)

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • AMR Lexington ( Site 0012)

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC ( Site 0013)

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)

    Springfield, Missouri 65802
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC ( Site 0013)

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Site Not Available

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)

    Springfield 4409896, Missouri 4398678 65802
    United States

    Site Not Available

  • AMR Clinical ( Site 0003)

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • AMR Clinical ( Site 0003)

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • ICON Early Phase Services ( Site 0006)

    San Antonio, Texas 78209
    United States

    Site Not Available

  • ICON Early Phase Services ( Site 0006)

    San Antonio 4726206, Texas 4736286 78209
    United States

    Site Not Available

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