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
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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RECRUITING
PHASE1
64 participants
INTERVENTIONAL
2025-09-22
2026-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MK-2828
Participants receive daily MK-2828 for 28 days.
MK-2828
Oral capsule of MK-2828 taken once per day for 28 days.
Placebo
Participants receive daily placebo for 28 days.
Placebo
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.
Placebo
Placebo to match MK-2828 oral capsule, taken once per day for 28 days.
Eligibility Criteria
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Inclusion Criteria
* 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 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
24 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)
Glendale, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0010)
Hallandale, Florida, United States
Jacksonville Center for Clinical Research ( Site 0002)
Jacksonville, Florida, United States
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, United States
QPS Miami Research Associates ( Site 0005)
South Miami, Florida, United States
AMR Lexington ( Site 0012)
Lexington, Kentucky, United States
Alliance for Multispecialty Research, LLC ( Site 0013)
Kansas City, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)
Springfield, Missouri, United States
AMR Clinical ( Site 0003)
Knoxville, Tennessee, United States
ICON Early Phase Services ( Site 0006)
San Antonio, Texas, United States
Countries
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Central Contacts
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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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Merck Clinical Trials Information
Other Identifiers
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2828-003
Identifier Type: -
Identifier Source: org_study_id