RecruitingPhase 1NCT07089784

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

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of MK-2828 in Participants With Type 2 Diabetes


Sponsor

Merck Sharp & Dohme LLC

Enrollment

64 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 24 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called MK-2828 — given in multiple doses — in people with Type 2 diabetes to see if it is safe and effective at improving blood sugar control. The drug works by reducing inflammation through blocking a specific pathway in the immune system (NLRP3). **You may be eligible if...** - You have had Type 2 diabetes for at least 1 year - Your HbA1c (a measure of long-term blood sugar control) is 10% or below - Your weight has been stable for at least 3 months - Your BMI is between 25 and 40 - You manage your diabetes with lifestyle changes or up to 3 oral medications **You may NOT be eligible if...** - You have Type 1 diabetes or other types of diabetes - You have significant heart disease, heart failure, or have had a stroke or heart attack within 6 months - You have had weight-loss surgery or use weight-loss devices - You have serious allergies to related drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-2828

Oral capsule of MK-2828 taken once per day for 28 days.

DRUGPlacebo

Placebo to match MK-2828 oral capsule, taken once per day for 28 days.


Locations(11)

ProSciento Inc. ( Site 0004)

Chula Vista, California, United States

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

Glendale, California, United States

Velocity Clinical Research, Hallandale Beach ( Site 0010)

Hallandale, Florida, United States

Jacksonville Center for Clinical Research ( Site 0002)

Jacksonville, Florida, United States

Advanced Pharma CR, LLC ( Site 0001)

Miami, Florida, United States

QPS Miami Research Associates ( Site 0005)

South Miami, Florida, United States

AMR Lexington ( Site 0012)

Lexington, Kentucky, United States

Alliance for Multispecialty Research, LLC ( Site 0013)

Kansas City, Missouri, United States

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

Springfield, Missouri, United States

AMR Clinical ( Site 0003)

Knoxville, Tennessee, United States

ICON Early Phase Services ( Site 0006)

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07089784


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