MK-1403 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on a new treatment called MK-1403, a potential drug for people with Type 2 diabetes. Researchers aim to determine if MK-1403 is safe and how the body processes it over time. They also seek to understand its effect on a blood protein linked to inflammation. Individuals with Type 2 diabetes who fall within a specific body weight range, measured by BMI, might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that MK-1403 is currently being tested for safety and tolerability in people with type 2 diabetes. As this is an early study, limited information exists on patient responses to the treatment. Being in the first phase means researchers are just beginning to observe its effects on humans.
Researchers closely monitor participants for any side effects in these studies. This process ensures the treatment's safety and helps identify potential risks. Although specific information on MK-1403's safety isn't available yet, early-phase trials focus on detecting any issues and determining if further study is warranted.
For those considering joining this study, safety remains a top priority. Participants receive close monitoring, and any side effects are recorded to protect them and enhance understanding of the treatment's safety.12345Why do researchers think this study treatment might be promising for type 2 diabetes?
MK-1403 is unique because it offers a potentially new approach to managing Type 2 Diabetes by combining an innovative active ingredient with an additive coformulation. Unlike standard treatments like Metformin, which primarily reduce glucose production in the liver, MK-1403 may target different pathways to enhance glucose regulation. Researchers are excited about the possibility that MK-1403, with its once-daily oral dosing, could provide a more effective or convenient option for patients, potentially improving adherence and outcomes.
What evidence suggests that MK-1403 might be an effective treatment for type 2 diabetes?
Research has shown that MK-1403 is under study for its potential to aid individuals with type 2 diabetes. Limited information from human studies exists on MK-1403, so researchers are examining its effects in the body. They focus on its impact on high-sensitivity C-reactive protein (hsCRP), an inflammation marker linked to diabetes complications. While direct proof of its benefits for type 2 diabetes is lacking, understanding its mechanism may offer valuable insights. This trial will test MK-1403 in various treatment arms, including combinations with additive coformulations, to assess its potential in managing diabetes by observing its effects over time.15678
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 people with Type 2 diabetes who have a body mass index (BMI) between 18 and 40 kg/m^2. Participants must have a confirmed diagnosis of Type 2 diabetes mellitus.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-1403 or placebo orally once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-1403
Trial Overview
The study tests MK-1403, which may affect blood levels of high-sensitivity C-reactive protein in those with Type 2 diabetes. It's compared to a placebo, both given with an additive coformulation.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
Participants will receive Placebo + additive coformulation dose 1 orally once daily.
Participants will receive Placebo + additive coformulation dose 2 orally once daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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
A Clinical Trial of MK-1403 in Participants With Type 2 ...
The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it ...
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and ...
In people with early T2DM treated only with diet and exercise (SURPASS-1), tirzepatide 5 to 15 mg improved the HbA1c by 1.87% to 2.07% compared to 0.04% ...
Articles The effectiveness of lifestyle interventions on type 2 ...
Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of HbA1c by 0·15% [−0· ...
Evaluating the Impact of Novel Incretin Therapies on ...
Evaluating the Impact of Novel Incretin Therapies on Cardiovascular Outcomes in Type 2 Diabetes: An Early Systematic Review. by. Teodor Salmen. Teodor Salmen.
Real-world treatment patterns in drug naïve type 2 diabetes ...
Clinical trials show early intensive treatment in type 2 diabetes enhances long-term glycemic control and lowers complication and mortality ...
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ctv.veeva.com
ctv.veeva.com/study/a-clinical-trial-of-mk-1403-in-participants-with-type-2-diabetes-mellitus-mk1403006A Clinical Trial of MK-1403 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-1403. The study will also measure ...
7.
htsyndication.com
htsyndication.com/health-daily-digest/article/clinical-trial%3A-a-clinical-trial-of-mk-1403-in-participants-with-type-2-diabetes-mellitus--mk-1403-006-/95113317A Clinical Trial of MK-1403 in Participants With Type 2 ...
Brief Summary: The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will ...
INNOVATIONS IN DIABETES MELLITUS MANAGEMENT
The study aimed to evaluate the effectiveness and safety of dapagliflozin as an additional therapy for patients with type 2 diabetes that had ...
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