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임상시험 NCT07242469은(는) 제2형 당뇨병에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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머크A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) 1상 52
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07242469은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 제2형 당뇨병에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 12월 22일에 시작되어 52명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2026년 8월 28일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 14일에 갱신되었습니다.
간단한 개요
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.
공식 제목
A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
질환명
제2형 당뇨병기타 연구 식별자
- 1403-006
NCT 번호
실제 연구 시작일
2025-12-22
최신 업데이트 게시
2026-01-14
예상 연구 완료일
2026-08-28
계획된 등록 인원
52
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
순차설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Panel A MK-1403 + additive coformulation dose 1 Participants will receive MK-1403 + additive coformulation dose 1 orally once daily. | MK-1403 + additive coformulation MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally. |
위약 대조군Panel A Placebo + additive coformulation dose 1 Participants will receive Placebo + additive coformulation dose 1 orally once daily. | Placebo + additive coformulation Placebo + additive coformulation is a co-formulated product of placebo administered orally. |
실험적Panel B MK-1403 + additive coformulation dose 2 Participants will receive MK-1403 + additive coformulation dose 2 orally once daily | MK-1403 + additive coformulation MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally. |
위약 대조군Panel B Placebo + additive coformulation dose 2 Participants will receive Placebo + additive coformulation dose 2 orally once daily | Placebo + additive coformulation Placebo + additive coformulation is a co-formulated product of placebo administered orally. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of participants who experience one or more adverse events (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. The number of participants who experience one or more AEs will be reported. | Up to approximately 28 days |
Number of participants who discontinue study intervention due to adverse events | 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. The number of participants who discontinue study intervention due to an AE will be reported. | Up to approximately 14 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. | Baseline and 24-hours postdose on Day 14 |
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14 | Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14. | 24-hour postdose on Day 14 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- Has body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- 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
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
4 1개국에 임상시험 장소
California
ProSciento Inc. ( Site 0001), Chula Vista, California, 91911, United States
Study Coordinator, 연락처, 619-427-1300
모집중
Florida
QPS-MRA, LLC ( Site 0004), Miami, Florida, 33143, United States
Study Coordinator, 연락처, 305-722-0970
모집중
Advanced Pharma CR, LLC ( Site 0003), Miami, Florida, 33147, United States
Study Coordinator, 연락처, 305-220-2727
모집중
Missouri
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005), Springfield, Missouri, 65802, United States
Study Coordinator, 연락처, 417-831-2048
모집중