Clinical Trials in Mexico / NCT07614984
Recruiting
Phase 2
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
NCT07614984 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Lipoprotein(a)
Investigational drug(s) / intervention(s)
MK-7262: Oral Coated Tablet
Enlicitide: Oral Coated Tablet
Placebo for MK-7262: Oral Coated Tablet
Placebo for enlicitide: Oral Coated Tablet
Study summary
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
Eligibility
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
Primary outcome measure(s)
- Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 — Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a). - Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 — Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C. - Number of Participants who Experience One or More Adverse Events (AEs) — Up to approximately 20 Weeks
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. - Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 12 Weeks
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 treatment due to an AE will be reported.
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Advanced Cardiovascular - Alexander City ( Site 0158) | Alexander City | Alabama | Recruiting |
| AMR Clinical Mobile ( Site 0149) | Mobile | Alabama | Recruiting |
| National Heart Institute ( Site 0113) | Beverly Hills | California | Recruiting |
| Headlands Research CTR Lincoln ( Site 0127) | Lincoln | California | Recruiting |
| Chase Medical Research, LLC ( Site 0163) | Waterbury | Connecticut | Recruiting |
| Soffer Health Institute ( Site 0123) | Hollywood | Florida | Recruiting |
| Westside Center for Clinical Research ( Site 0161) | Jacksonville | Florida | Recruiting |
| Inpatient Research Clinic ( Site 0110) | Miami Lakes | Florida | Recruiting |
| Clinical Research Trials of Florida ( Site 0101) | Tampa | Florida | Recruiting |
| Conquest Research LLC ( Site 0140) | Winter Park | Florida | Recruiting |
| Flourish Research - Bowie ( Site 0106) | Bowie | Maryland | Recruiting |
| Velocity Clinical Research Rockville ( Site 0146) | Rockville | Maryland | Recruiting |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132) | Troy | Michigan | Recruiting |
| Minneapolis Heart Institute - Minneapolis ( Site 0130) | Minneapolis | Minnesota | Recruiting |
| Montana Medical Research, Inc. ( Site 0156) | Missoula | Montana | Recruiting |
| New Mexico Clinical Research & Osteoporosis Center ( Site 0119) | Albuquerque | New Mexico | Recruiting |
| Laurelton Heart Specialist PC ( Site 0155) | Rosedale | New York | Recruiting |
| Velocity Clinical Research, Durham ( Site 0145) | Durham | North Carolina | Recruiting |
| Remington-Davis, Inc. ( Site 0107) | Columbus | Ohio | Recruiting |
| Holston Medical Group ( Site 0117) | Kingsport | Tennessee | Recruiting |
| Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154) | Houston | Texas | Recruiting |
| DM Clinical Research ( Site 0115) | Tomball | Texas | Recruiting |
| Carient Heart & Vascular - Manassas ( Site 0165) | Manassas | Virginia | Recruiting |
| Rainier Clinical Research Center ( Site 0116) | Renton | Washington | Recruiting |
| North York Diagnostic and Cardiac Centre ( Site 0203) | North York | Ontario | Recruiting |
| Clinique des Maladies Lipidiques de Quebec ( Site 0201) | Québec | Quebec | Recruiting |
| Salud SURA Industriales ( Site 0405) | Medellín | Antioquia | Recruiting |
| Clinica de la Costa S.A.S ( Site 0404) | Barranquilla | Atlántico | Recruiting |
| Solano & Terront Servicios Medicos - UNIENDO SAS ( Site 0402) | Bogota | Cundinamarca | Recruiting |
| IMAT S.A.S ( Site 0400) | Montería | Departamento de Córdoba | Recruiting |
| Regionshospitalet Viborg ( Site 0507) | Viborg | Central Jutland | Recruiting |
| Sanos Clinic - Nordjylland ( Site 0502) | Gandrup | North Denmark | Recruiting |
| Esbjerg sygehus, Syddansk Universitetshospital ( Site 0505) | Esbjerg | Region Syddanmark | Recruiting |
| OUH Svendborg Sygehus ( Site 0500) | Svendborg | Region Syddanmark | Recruiting |
| Klinikum Konstanz ( Site 0723) | Konstanz | Baden-Wurttemberg | Recruiting |
| Deutsches Herzzentrum Muenchen ( Site 0717) | Munich | Bavaria | Recruiting |
| Ambulantes Herzzentrum Kassel ( Site 0721) | Kassel | Hesse | Recruiting |
| Dedicated Research Site FutureMeds ( Site 0719) | Offenbach | Hesse | Recruiting |
| Studienzentrum Brinkum - Torsten Drescher & Dr. Lars Pohlmeier ( Site 0712) | Stuhr | Lower Saxony | Recruiting |
| Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden' ( Site 0713) | Dresden | Saxony | Recruiting |
+ 30 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Mexico
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Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07614984 on ClinicalTrials.gov ↗ ← All trials in Mexico