Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT07089784
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 46
- Starts
- 2025-09-22
- Expected to finish
- 2026-05-04
- Last updated by the study team
- 2026-05-22
Who can join
Age: 24 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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