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Completed

NCT Number: NCT07089784

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

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.

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Key information

Age range

24 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ProSciento Inc. ( Site 0004), Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-2828

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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 outcomes

  1. Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose

    Time frame: 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.

  2. Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose

    Time frame: Predose on Day 28

    Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 27 dose.

  3. Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration

    Time frame: Baseline and Predose Day 28

    Blood samples will be collected to determine the change from baseline in placebo corrected hsCRP.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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