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Recruiting NCT07614984

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

Phase II Interventional Lipoprotein(a)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-7262, Enlicitide, Placebo for MK-7262, Placebo for enlicitide.
Who it may be relevant to
Registry conditions: Lipoprotein(a). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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

Interventions

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

Primary outcome measures

  • Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 [Time frame: Baseline and Week 8]
  • Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 [Time frame: Baseline and Week 8]
  • Number of Participants who Experience One or More Adverse Events (AEs) [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 outcome measures (8)
  • Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo) [Time frame: Baseline and Week 8]
  • Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo) [Time frame: Baseline and Week 8]
  • Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. 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) [Time frame: Baseline and Week 8]
  • Percentage of Participants with Lp(a) <125 nmol/L at Week 8 [Time frame: Week 8]
  • Percentage of Participants with Lp(a) <75 nmol/L at Week 8 [Time frame: Week 8]
  • Percent Change from Baseline in Lp(a) at Week 12 [Time frame: Baseline and Week 12]
  • Percent Change from Baseline in LDL-C at Week 12 [Time frame: Baseline and Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • 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
  • … and 12 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗