MK-2828 for Type 2 Diabetes

Recruiting at 10 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Oral anti-diabetics

Must not be taking: NLRP3i therapy

Disqualifiers: Congestive heart failure, Myocardial infarction, Type 1 diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new medicine, MK-2828, is safe and well-tolerated in people with type 2 diabetes. It will also monitor how the body processes the drug and its effects on inflammation markers in the blood. Participants will receive either the actual drug or a placebo (a look-alike pill with no active ingredients) for 28 days. Suitable candidates have had type 2 diabetes for at least a year, manage it with lifestyle changes or stable medication, and maintain a consistent weight. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop your current medications, but you must be on stable doses of up to 3 oral anti-diabetic medications for at least 3 months before the trial and not need dose changes during the study.

Is there any evidence suggesting that MK-2828 is likely to be safe for humans?

Research shows that MK-2828 is currently being tested for safety and tolerability. This study examines the effects of MK-2828 in individuals with Type 2 diabetes over time.

As an early-stage study, detailed safety information may not yet be available. However, early trials primarily focus on ensuring the treatment's safety for participants. Researchers closely monitor for any side effects or adverse reactions. Any major safety issues would likely be addressed before advancing to later research stages. It is important to consult a healthcare provider to understand the treatment and its potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes?

Unlike the standard treatments for Type 2 Diabetes, such as metformin and insulin, MK-2828 is unique because it may offer a new approach to managing the condition. Researchers are excited about MK-2828 because it operates through a novel mechanism of action that targets specific pathways involved in glucose regulation, potentially offering improved control of blood sugar levels. This could mean fewer side effects and a more targeted treatment option for patients, setting it apart from existing therapies.

What evidence suggests that MK-2828 might be an effective treatment for type 2 diabetes?

This trial will compare MK-2828 with a placebo to evaluate its effects on type 2 diabetes. Researchers are examining how MK-2828 affects levels of high-sensitivity C-reactive protein (hsCRP), a protein linked to inflammation and diabetes. Although direct evidence on MK-2828's effectiveness remains limited, focusing on hsCRP is promising, as reducing inflammation could aid in managing diabetes. The trial aims to understand how MK-2828 functions in the body and its tolerability in people with type 2 diabetes. Further research is necessary to confirm its benefits for diabetes management. ^{1 5 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes who have an HbA1C level greater than 6.5% but not exceeding 10%, a BMI between 25 and 40, and are generally healthy aside from diabetes. Participants should be managing their diabetes through lifestyle or stable doses of up to three oral medications without changes for the last three months.

Inclusion Criteria

The main

I am in good health, except for type 2 diabetes.

My HbA1C level is between 6.5% and 10%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily MK-2828 or placebo for 28 days

4 weeks

Daily visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-2828

Trial Overview The study tests MK-2828's safety, tolerance, how it behaves in the body over time (pharmacokinetics), and its impact on blood levels of high-sensitivity C-reactive protein (hsCRP) compared to a placebo in people with Type 2 Diabetes.

How Is the Trial Designed?

Group I: MK-2828 Experimental Treatment 1 Intervention

Participants receive daily MK-2828 for 28 days.

Group II: Placebo Placebo Group 1 Intervention

Participants receive daily placebo for 28 days.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089784

Multiple Dose Study of MK-2828 in Participants With Type ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40628673/

Effectiveness of semaglutide on survival outcomes in ... Conclusions: In patients with T2D and CKD, semaglutide was associated with a lower 3-year risk of all-cause death compared with sitagliptin.

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0029752

Type 2 Diabetes Mellitus (DBCOND0029752) Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003) ... Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study ...

4. diabetesjournals.org diabetesjournals.org/care/article/46/7/1316/151548/Use-of-Real-World-Data-in-Population-Science-to

Use of Real-World Data in Population Science to Improve the ... This report reviews the current landscape and applications of RWD in clinical effectiveness and population health research for diabetes

5. withpower.com withpower.com/clinical-trials/for-type-2-diabetes?page=3

Top Type 2 Diabetes Clinical Trials | Power This trial is testing a new diabetes medicine called semaglutide. It focuses on children and teenagers with type 2 diabetes to see if the new medicine is safe ...

6. ctv.veeva.com ctv.veeva.com/study/multiple-dose-study-of-mk-2828-in-participants-with-type-2-diabetes-mk2828003

Multiple Dose Study of MK-2828 in Participants With Type 2 ... 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 ...

7. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-type-2-7-2025-0ddd3

MK-2828 for 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 ...

8. merck.com merck.com/news/merck-announces-phase-3-trial-initiations-for-four-investigational-candidates-from-its-promising-hematology-and-oncology-pipeline/

Merck Announces Phase 3 Trial Initiations for Four ... Global Phase 3 studies started for bomedemstat (LSD1 inhibitor), nemtabrutinib (BTK inhibitor), MK-2870 (anti-TROP2 ADC) and MK-5684 (CYP11A1 inhibitor).