MK-1403 for adults with type 2 diabetes

A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus

This early-phase trial will test MK-1403 in adults with type 2 diabetes to see if it is safe, tolerated, and how it moves through the body while tracking hsCRP levels.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Merck Sharp & Dohme LLC (industry)
• Locations: 4 sites (Chula Vista, California and 3 other locations)
• Trial ID: NCT07242469 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study gives adults with type 2 diabetes either MK-1403 plus an additive coformulation or a matching placebo plus the coformulation and monitors participants over time. The main goals are to characterize safety, tolerability, and the pharmacokinetics (PK) of MK-1403 and to measure changes in high-sensitivity C-reactive protein (hsCRP). Key exclusions include type 1 diabetes, significant cardiac history, active malignancy, positive hepatitis/HIV tests, and prior gastrointestinal bypass that could affect absorption. Study visits and blood sampling will capture PK timepoints and safety labs at the listed clinical research sites.

Who should consider this trial

Good fit: Adults with confirmed type 2 diabetes and a BMI of 18–40 kg/m2 who do not have severe cardiac disease, active cancer, positive hepatitis/HIV tests, or prior gastric bypass surgery are the intended participants.

Not a fit: People with type 1 diabetes, major heart disease (NYHA Class 3–4 or recent cardiac events), active malignancy, positive hepatitis or HIV tests, or prior gastrointestinal bypass surgery would be excluded and are unlikely to benefit from this early safety-focused trial.

Why it matters

Potential benefit: If MK-1403 is found to be safe with favorable PK and biomarker effects, it could progress to later trials that may lead to a new treatment option for people with type 2 diabetes.

How similar studies have performed: This is an early-phase PK and safety study; while other Phase 1 diabetes drug trials have sometimes shown acceptable safety and short-term biomarker changes, clinical benefit must be demonstrated in later-phase studies.

Eligibility criteria

Inclusion Criteria:

* Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
* Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive

Exclusion Criteria:

* Has Type 1 diabetes mellitus or secondary types of diabetes
* Has a history of congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4)
* Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
* Has history of cancer (malignancy)
* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
* Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery

Where this trial is running

Chula Vista, California and 3 other locations

• ProSciento Inc. ( Site 0001) — Chula Vista, California, United States (RECRUITING)
• QPS-MRA, LLC ( Site 0004) — Miami, Florida, United States (RECRUITING)
• Advanced Pharma CR, LLC ( Site 0003) — Miami, Florida, United States (RECRUITING)
• Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005) — Springfield, Missouri, United States (RECRUITING)

Study contacts

• Study coordinator: Toll Free Number

Conditions: Diabetes Mellitus, Type 2