A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: MK-1403 + additive coformulation; Drug: Placebo + additive coformulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07242469

1403-006

Details and patient eligibility

About

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 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 affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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52 participants in 4 patient groups, including a placebo group

Panel A MK-1403 + additive coformulation dose 1

Experimental group

Description:

Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.

Treatment:

Drug: MK-1403 + additive coformulation

Panel A Placebo + additive coformulation dose 1

Placebo Comparator group

Description:

Participants will receive Placebo + additive coformulation dose 1 orally once daily.

Treatment:

Drug: Placebo + additive coformulation

Panel B MK-1403 + additive coformulation dose 2

Experimental group

Description:

Participants will receive MK-1403 + additive coformulation dose 2 orally once daily

Treatment:

Drug: MK-1403 + additive coformulation

Panel B Placebo + additive coformulation dose 2

Placebo Comparator group

Description:

Participants will receive Placebo + additive coformulation dose 2 orally once daily

Treatment:

Drug: Placebo + additive coformulation