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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: MK-2828; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07089784

2828-003

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 24 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion criteria include but are not limited to the following:

Inclusion Criteria:

• 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:

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

MK-2828

Experimental group

Description:

Participants receive daily MK-2828 for 28 days.

Treatment:

Drug: MK-2828

Placebo

Placebo Comparator group

Description:

Participants receive daily placebo for 28 days.

Treatment:

Drug: Placebo