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

NCT07089784 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2828-003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  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.

  Up to approximately 42 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  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.

  Up to approximately 28 days

Secondary Outcomes (3)

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

  24 hours post-Day 1 dose

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

  Predose on Day 28

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

  Baseline and Predose Day 28

Study Arms (2)

MK-2828

EXPERIMENTAL

Participants receive daily MK-2828 for 28 days.

Drug: MK-2828

Placebo

PLACEBO COMPARATOR

Participants receive daily placebo for 28 days.

Drug: Placebo

Interventions

MK-2828 DRUG

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

MK-2828

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 24 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (11)

ProSciento Inc. ( Site 0004)

Chula Vista, California, 91911, United States

Location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

Glendale, California, 91206, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0010)

Hallandale, Florida, 33009, United States

Location

Jacksonville Center for Clinical Research ( Site 0002)

Jacksonville, Florida, 32216, United States

Location

Advanced Pharma CR, LLC ( Site 0001)

Miami, Florida, 33147, United States

Location

QPS Miami Research Associates ( Site 0005)

South Miami, Florida, 33143, United States

Location

AMR Lexington ( Site 0012)

Lexington, Kentucky, 40509, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0013)

Kansas City, Missouri, 64114, United States

Location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)

Springfield, Missouri, 65802, United States

Location

AMR Clinical ( Site 0003)

Knoxville, Tennessee, 37920, United States

Location

ICON Early Phase Services ( Site 0006)

San Antonio, Texas, 78209, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start: September 22, 2025
• Primary Completion: May 6, 2026
• Study Completion: May 6, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (11)