Diabetes Mellitus, Type 2Phase 1NCT07089784
Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
A Phase 1 study testing MK-2828 in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MK-2828
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Sep 2025to 4 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
ProSciento Inc. ( Site 0004)
Chula Vista, California, 91911
California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)
Glendale, California, 91206
Velocity Clinical Research, Hallandale Beach ( Site 0010)
Hallandale, Florida, 33009
Jacksonville Center for Clinical Research ( Site 0002)
Jacksonville, Florida, 32216
Alliance for Multispecialty Research, LLC ( Site 0013)
Kansas City, Missouri, 64114
AMR Clinical ( Site 0003)
Knoxville, Tennessee, 37920
AMR Lexington ( Site 0012)
Lexington, Kentucky, 40509
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, 33147
ICON Early Phase Services ( Site 0006)
San Antonio, Texas, 78209
QPS Miami Research Associates ( Site 0005)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0009)
Springfield, Missouri, 65802
About this study
Official 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
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
- Being tested
- MK-2828, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2828Drug
Oral capsule of MK-2828 taken once per day for 28 days.
PlaceboDrug
Placebo to match MK-2828 oral capsule, taken once per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| MK-2828 | Experimental | Participants receive daily MK-2828 for 28 days. Receives: Drug: MK-2828 |
| Placebo | Placebo comparator | Participants receive daily placebo for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 28 days
Secondary outcomes (3)
Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose
Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 1 dose.
Measured: 24 hours post-Day 1 dose
Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose
Blood samples will be collected to determine the C24 of MK-2828 in plasma after the Day 27 dose.
Measured: Predose on Day 28
Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Blood samples will be collected to determine the change from baseline in placebo corrected hsCRP.
Measured: Baseline and Predose Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start22 Sep 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089784
- Sponsor's protocol ID
- 2828-003
- Status last verified
- May 2026
- First submitted
- 25 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07089784
- Acronym / sponsor ID
- 2828-003
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-2828 | Experimental | Drug: MK-2828Participants receive daily MK-2828 for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive daily placebo for 28 days. |
Who may qualify
- Ages
- 24 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-2828Oral capsule of MK-2828 taken once per day for 28 days. | Drug | MK-2828 |
| PlaceboPlacebo to match MK-2828 oral capsule, taken once per day for 28 days. | Drug | Placebo |
Primary outcome
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.
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.
3 secondary outcomes
Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose
Time frame: 24 hours post-Day 1 dose
Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose
Time frame: Predose on Day 28
Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Time frame: Baseline and Predose Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-2828 in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.