A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and When Coadministered With Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)

Обзор

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C). The goals of this trial are to evaluate: * if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood * if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood * the safety and tolerability of taking MK-7262 and enlicitide alone and together

Вмешательства

• Препарат MK-7262
  Oral Coated Tablet
• Препарат Enlicitide
  Oral Coated Tablet
• Препарат Placebo for MK-7262
  Oral Coated Tablet
• Препарат Placebo for enlicitide
  Oral Coated Tablet

Первичные конечные точки

• Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 [Срок оценки: Baseline and Week 8]
• Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 [Срок оценки: Baseline and Week 8]
• Number of Participants who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 20 Weeks]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 12 Weeks]

Вторичные конечные точки (8)

• Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo) [Срок оценки: Baseline and Week 8]
• Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo) [Срок оценки: Baseline and Week 8]
• Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy) [Срок оценки: Baseline and Week 8]
• Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy) [Срок оценки: Baseline and Week 8]
• Percentage of Participants with Lp(a) <125 nmol/L at Week 8 [Срок оценки: Week 8]
• Percentage of Participants with Lp(a) <75 nmol/L at Week 8 [Срок оценки: Week 8]
• Percent Change from Baseline in Lp(a) at Week 12 [Срок оценки: Baseline and Week 12]
• Percent Change from Baseline in LDL-C at Week 12 [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Has Lp(a) ≥ 150 nmol/L
• Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
• Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization
• Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load)
• Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection
• Has a history of nephrotic syndrome
• Has severe renal insufficiency
• Has received certain therapies in the prohibited timeframe as specified in the protocol
• Has active or chronic hepatobiliary or hepatic disease
• Has poorly controlled Type 1 or Type 2 diabetes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Advanced Cardiovascular - Alexander City ( Site 0158) — Alexander City
• AMR Clinical Mobile ( Site 0149) — Mobile
• National Heart Institute ( Site 0113) — Beverly Hills
• Headlands Research CTR Lincoln ( Site 0127) — Lincoln
• Chase Medical Research, LLC ( Site 0163) — Waterbury
• Soffer Health Institute ( Site 0123) — Hollywood
• Westside Center for Clinical Research ( Site 0161) — Jacksonville
• Inpatient Research Clinic ( Site 0110) — Miami Lakes
• … и ещё 12 центров

Идентификаторы

NCT: NCT07614984 · 7262-004 · MK-7262-004 · U1111-1333-1832 · 2025-525102-38-00 · jRCT2021260024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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