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

11. september 2026 oppdatert av: Merck Sharp & Dohme LLC

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)

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

750

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Ontario
      • North York, Ontario, Canada, M6B 3H7
        • Rekruttering
        • North York Diagnostic and Cardiac Centre ( Site 0203)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 416-783-0000
    • Quebec
      • Québec, Quebec, Canada, G1V 4W2
        • Rekruttering
        • Clinique des Maladies Lipidiques de Quebec ( Site 0201)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 418-780-1376
  • Danmark
    • Central Jutland
      • Viborg, Central Jutland, Danmark, 8800
        • Rekruttering
        • Regionshospitalet Viborg ( Site 0507)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +4521269495
    • North Denmark
      • Gandrup, North Denmark, Danmark, 9362
        • Rekruttering
        • Sanos Clinic - Nordjylland ( Site 0502)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +45 73708220
  • Forente stater
    • Alabama
      • Alexander City, Alabama, Forente stater, 35010
        • Rekruttering
        • Advanced Cardiovascular - Alexander City ( Site 0158)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 256-215-5323
      • Mobile, Alabama, Forente stater, 36608
        • Rekruttering
        • AMR Clinical Mobile ( Site 0149)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 251-414-1984
    • California
      • Beverly Hills, California, Forente stater, 90211-2285
        • Rekruttering
        • National Heart Institute ( Site 0113)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 310-289-5221
      • Lincoln, California, Forente stater, 95648
        • Rekruttering
        • Headlands Research CTR Lincoln ( Site 0127)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 916-434-8230
    • Connecticut
      • Waterbury, Connecticut, Forente stater, 06708
        • Rekruttering
        • Chase Medical Research, LLC ( Site 0163)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 203-419-4420
    • Florida
      • Hollywood, Florida, Forente stater, 33020
        • Rekruttering
        • Soffer Health Institute ( Site 0123)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 305-250-2106
      • Jacksonville, Florida, Forente stater, 32205
        • Rekruttering
        • Westside Center for Clinical Research ( Site 0161)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 904-693-1490
      • Miami Lakes, Florida, Forente stater, 33014
        • Rekruttering
        • Inpatient Research Clinic ( Site 0110)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 786-502-4303
      • Tampa, Florida, Forente stater, 33607
        • Rekruttering
        • Clinical Research Trials of Florida ( Site 0101)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 813-873-8102
      • Winter Park, Florida, Forente stater, 32789
        • Rekruttering
        • Conquest Research LLC ( Site 0140)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 407-916-0060
    • Maryland
      • Bowie, Maryland, Forente stater, 20715
        • Rekruttering
        • Flourish Research - Bowie ( Site 0106)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 410-824-1341
      • Rockville, Maryland, Forente stater, 20854
        • Rekruttering
        • Velocity Clinical Research Rockville ( Site 0146)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 240-698-2800
    • Michigan
      • Troy, Michigan, Forente stater, 48098
        • Rekruttering
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 248-312-0025
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Rekruttering
        • Minneapolis Heart Institute - Minneapolis ( Site 0130)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 612-863-3833
    • Montana
      • Missoula, Montana, Forente stater, 59808
        • Rekruttering
        • Montana Medical Research, Inc. ( Site 0156)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 406-549-1124
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Rekruttering
        • New Mexico Clinical Research & Osteoporosis Center ( Site 0119)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 505-855-5505
    • New York
      • Rosedale, New York, Forente stater, 11422
        • Rekruttering
        • Laurelton Heart Specialist PC ( Site 0155)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 718-949-9400
    • North Carolina
      • Durham, North Carolina, Forente stater, 27701
        • Rekruttering
        • Velocity Clinical Research, Durham ( Site 0145)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 919-503-4711
    • Ohio
      • Columbus, Ohio, Forente stater, 43215
        • Rekruttering
        • Remington-Davis, Inc. ( Site 0107)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 614-487-2560
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • Rekruttering
        • Holston Medical Group ( Site 0117)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 423-857-2789
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 713-798-5800
      • Tomball, Texas, Forente stater, 77375
        • Rekruttering
        • DM Clinical Research ( Site 0115)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 346-550-9559
    • Virginia
      • Manassas, Virginia, Forente stater, 20109
        • Rekruttering
        • Carient Heart & Vascular - Manassas ( Site 0165)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 571-581-1771
    • Washington
      • Renton, Washington, Forente stater, 98057
        • Rekruttering
        • Rainier Clinical Research Center ( Site 0116)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 425-251-1720
  • Japan
      • Fukuoka, Japan, 810-0001
        • Rekruttering
        • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 2400)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-92-738-3335
      • Nagasaki, Japan, 852-8034
        • Rekruttering
        • Midori Clinic ( Site 2401)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-95-844-7191
    • Osaka
      • Suita, Osaka, Japan, 565-0853
        • Rekruttering
        • Medical Corporation Heishinkai OCROM Clinic ( Site 2403)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-6-6330-8810
    • Tokyo
      • Arakawa City, Tokyo, Japan, 116-0012
        • Rekruttering
        • Kumanomae Nishimura Naika Clinic ( Site 2407)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-3-5855-7555
      • Hachiōji, Tokyo, Japan, 192-0918
        • Rekruttering
        • Minamino Cardiovascular Hospital ( Site 2406)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-42-637-8101
      • Katsushika-ku, Tokyo, Japan, 125-0054
        • Rekruttering
        • Kato Clinic of Internal Medicine ( Site 2402)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-3-5668-2161
      • Musashino, Tokyo, Japan, 180-0022
        • Rekruttering
        • Swing Nozaki Clinic ( Site 2405)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-422-36-3534
      • Shinjuku, Tokyo, Japan, 160-0008
        • Rekruttering
        • Medical Corporation Heishinkai ToCROM Clinic ( Site 2404)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +81-3-5366-5333
  • Nederland
      • Groningen, Nederland, 9728 NT
        • Rekruttering
        • Martini Ziekenhuis ( Site 1108)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 31505245641
    • Gelderland
      • Ede, Gelderland, Nederland, 6716 RP
        • Rekruttering
        • Ziekenhuis Gelderse Vallei ( Site 1106)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +31318435855
      • Harderwijk, Gelderland, Nederland, 3844 DG
        • Rekruttering
        • Ziekenhuis St. Jansdal ( Site 1113)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +310341463883
    • North Brabant
      • Roosendaal, North Brabant, Nederland, 4708 AE
        • Rekruttering
        • Bravis Ziekenhuis, locatie Roosendaal ( Site 1102)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 31887068000
    • Provincie Friesland
      • Sneek, Provincie Friesland, Nederland, 8601 ZR
        • Rekruttering
        • Antonius Ziekenhuis, locatie D&A Research and Genetics ( Site 1103)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 0515-434275
    • South Holland
      • Dordrecht, South Holland, Nederland, 3318 AT
        • Rekruttering
        • Albert Schweitzer Ziekenhuis, locatie Dordwijk ( Site 1101)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +31786523366
  • Spania
      • Seville, Spania, 41003
        • Rekruttering
        • Nuevas Tecnologías en D y E - Sevillaocío ( Site 1412)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +34656193053
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spania, 41950
        • Rekruttering
        • Vithas Hospital Sevilla ( Site 1401)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +34658011529
  • Sveits
      • Geneva, Sveits, 1211
        • Rekruttering
        • Hopitaux Universitaires (Geneve) ( Site 1704)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +41223727192
      • Lucerne, Sveits, 6000
        • Rekruttering
        • Luzerner Kantonsspital ( Site 1702)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +41412055000
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Sveits, 9007
        • Rekruttering
        • HOCH Health Ostschweiz ( Site 1703)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: 41714941228
  • Tyskland
      • Berlin, Tyskland, 10439
        • Rekruttering
        • zibp GmbH ( Site 0716)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +4930233212880
      • Berlin, Tyskland, 10629
        • Rekruttering
        • FutureMeds GmbH ( Site 0718)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +4930439741610
      • Berlin, Tyskland, 12203
        • Rekruttering
        • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +493045061847
    • Baden-Wurttemberg
      • Konstanz, Baden-Wurttemberg, Tyskland, 78464
        • Rekruttering
        • Klinikum Konstanz ( Site 0723)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +497538010
    • Hesse
      • Kassel, Hesse, Tyskland, 34121
        • Rekruttering
        • Ambulantes Herzzentrum Kassel ( Site 0721)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +49561937690
      • Offenbach, Hesse, Tyskland, 63065
        • Rekruttering
        • Dedicated Research Site FutureMeds ( Site 0719)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +4969247433849
    • Lower Saxony
      • Stuhr, Lower Saxony, Tyskland, 28816
        • Rekruttering
        • Studienzentrum Brinkum - Torsten Drescher & Dr. Lars Pohlmeier ( Site 0712)
        • Ta kontakt med:
          • Study Coordinator
          • Telefonnummer: +494218305310

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Legemiddel: Placebo for MK-7262
Oral Coated Tablet
Legemiddel: Placebo for enlicitide
Oral Coated Tablet
Aktiv komparator: enlicitide monotherapy
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Legemiddel: Placebo for MK-7262
Oral Coated Tablet
Legemiddel: Enlicitide
Oral Coated Tablet
Andre navn:
  • MK-0616
  • enlicitide dekanoat
Eksperimentell: MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Legemiddel: Placebo for enlicitide
Oral Coated Tablet
Legemiddel: MK-7262
Oral Coated Tablet
Andre navn:
  • HRS-5346
Eksperimentell: MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
Legemiddel: Enlicitide
Oral Coated Tablet
Andre navn:
  • MK-0616
  • enlicitide dekanoat
Legemiddel: MK-7262
Oral Coated Tablet
Andre navn:
  • HRS-5346

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8
Tidsramme: 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).
Baseline and Week 8
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Tidsramme: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.
Baseline and Week 8
Number of Participants who Experience One or More Adverse Events (AEs)
Tidsramme: 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.
Up to approximately 20 Weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Tidsramme: 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.
Up to approximately 12 Weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)
Tidsramme: Baseline and Week 8
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.
Baseline and Week 8
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)
Tidsramme: Baseline and Week 8
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.
Baseline and Week 8
Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)
Tidsramme: Baseline and Week 8
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.
Baseline and Week 8
Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)
Tidsramme: Baseline and Week 8
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.
Baseline and Week 8
Percentage of Participants with Lp(a) <125 nmol/L at Week 8
Tidsramme: 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.
Week 8
Percentage of Participants with Lp(a) <75 nmol/L at Week 8
Tidsramme: 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.
Week 8
Percent Change from Baseline in Lp(a) at Week 12
Tidsramme: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a).
Baseline and Week 12
Percent Change from Baseline in LDL-C at Week 12
Tidsramme: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C.
Baseline and Week 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2026

Primær fullføring (Antatt)

12. oktober 2027

Studiet fullført (Antatt)

12. oktober 2027

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 7262-004
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • MK-7262-004 (Annen identifikator: MSD)
  • U1111-1333-1832 (Registeridentifikator: UTN)
  • 2025-525102-38-00 (Registeridentifikator: EU CT)
  • jRCT2021260024 (Registeridentifikator: jRCT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere