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Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
NCT07089784 · Merck Sharp & Dohme LLC
In plain English
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Official title
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
About this study
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 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
Study design
Enrollment target: 64 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-09-22
Estimated completion: 2026-06-29
Last updated: 2026-02-12
Interventions
Drug: MK-2828Drug: Placebo
Primary outcomes
- • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 42 days)
- • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 28 days)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (11)
ProSciento Inc. ( Site 0004)Recruiting
Chula Vista, California, United States
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)Recruiting
Glendale, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0010)Recruiting
Hallandale, Florida, United States
Jacksonville Center for Clinical Research ( Site 0002)Recruiting
Jacksonville, Florida, United States
Advanced Pharma CR, LLC ( Site 0001)Recruiting
Miami, Florida, United States
QPS Miami Research Associates ( Site 0005)Recruiting
South Miami, Florida, United States
AMR Lexington ( Site 0012)Recruiting
Lexington, Kentucky, United States
Alliance for Multispecialty Research, LLC ( Site 0013)Recruiting
Kansas City, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)Recruiting
Springfield, Missouri, United States
AMR Clinical ( Site 0003)Recruiting
Knoxville, Tennessee, United States
ICON Early Phase Services ( Site 0006)Recruiting
San Antonio, Texas, United States