Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: MK-2828Drug: Placebo
- Registration Number
- NCT07089784
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 64
- With the exception of 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 >6.5% and ≤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 (see Table 1) and anticipated not to require dose adjustments during the study duration
- BMI between 25 and 40 kg/m2, inclusive
The main exclusion criteria include but are not limited to the following:
- Has known systemic hypersensitivity to the MK-2828 drug substance or other 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MK-2828 MK-2828 Participants receive daily MK-2828 for 28 days. Placebo Placebo Participants receive daily placebo for 28 days.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 42 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 28 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Secondary Outcome Measures
Name Time Method Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose 24 hours post-Day 1 dose Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 1 dose.
Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose Predose on Day 28 Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 27 dose.
Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration Baseline and Predose Day 28 Blood samples will be collected to determine the change from baseline in placebo corrected hsCRP.