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

NCT ID: NCT07089784

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2026-01-12

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-2828

Participants receive daily MK-2828 for 28 days.

Group Type EXPERIMENTAL

MK-2828

Intervention Type DRUG

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

Placebo

Participants receive daily placebo for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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MK-2828

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

24 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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ProSciento Inc. ( Site 0004)

Chula Vista, California, United States

Site Status RECRUITING

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

Glendale, California, United States

Site Status RECRUITING

Velocity Clinical Research, Hallandale Beach ( Site 0010)

Hallandale, Florida, United States

Site Status RECRUITING

Jacksonville Center for Clinical Research ( Site 0002)

Jacksonville, Florida, United States

Site Status RECRUITING

Advanced Pharma CR, LLC ( Site 0001)

Miami, Florida, United States

Site Status RECRUITING

QPS Miami Research Associates ( Site 0005)

South Miami, Florida, United States

Site Status RECRUITING

AMR Lexington ( Site 0012)

Lexington, Kentucky, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0013)

Kansas City, Missouri, United States

Site Status RECRUITING

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

Springfield, Missouri, United States

Site Status RECRUITING

AMR Clinical ( Site 0003)

Knoxville, Tennessee, United States

Site Status RECRUITING

ICON Early Phase Services ( Site 0006)

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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2828-003

Identifier Type: -

Identifier Source: org_study_id