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

Phase 2RecruitingNCT07614984

Merck Sharp & Dohme LLC750 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

750

Conditions

Lipoprotein(a)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

Locations (54)

Advanced Cardiovascular - Alexander City ( Site 0158)

Alexander City, Alabama, United States

RECRUITING

AMR Clinical Mobile ( Site 0149)

Mobile, Alabama, United States

RECRUITING

National Heart Institute ( Site 0113)

Beverly Hills, California, United States

RECRUITING

Headlands Research CTR Lincoln ( Site 0127)

Lincoln, California, United States

Outcomes

Primary Outcomes

Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).

Time frame: Baseline and Week 8

Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.

Time frame: Baseline and Week 8

Number of Participants who Experience One or More Adverse Events (AEs)

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 an AE will be reported.

Time frame: Up to approximately 20 Weeks

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 12 Weeks

Secondary Outcomes

Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with enlicitide monotherapy versus placebo.

Time frame: Baseline and Week 8

Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 monotherapy versus placebo.

Time frame: Baseline and Week 8

Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in Lp(a) between participants treated with MK-7262 + enlicitide versus MK-7262 monotherapy.

Time frame: Baseline and Week 8

Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)

Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 + enlicitide versus enlicitide monotherapy.

Time frame: Baseline and Week 8

Percentage of Participants with Lp(a) <125 nmol/L at Week 8

Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) \<125 nmol/L. The percentage of participants with Lp(a) \<125 nmol/L at week 8 will be reported.

Time frame: Week 8

Percentage of Participants with Lp(a) <75 nmol/L at Week 8

Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) \<75 nmol/L. The percentage of participants with Lp(a) \<75 nmol/L at week 8 will be reported.

Time frame: Week 8

Percent Change from Baseline in Lp(a) at Week 12

Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a).

Time frame: Baseline and Week 12

Percent Change from Baseline in LDL-C at Week 12

Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C.

Time frame: Baseline and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (54)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts