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

22. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

750

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Medicin: Placebo for MK-7262
Oral Coated Tablet
Medicin: 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.
Medicin: Placebo for MK-7262
Oral Coated Tablet
Medicin: Enlicitide
Oral Coated Tablet
Andre navne:
  • MK-0616
  • enlicitide decanoat
Eksperimentel: MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Medicin: Placebo for enlicitide
Oral Coated Tablet
Medicin: MK-7262
Oral Coated Tablet
Andre navne:
  • HRS-5346
Eksperimentel: MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
Medicin: Enlicitide
Oral Coated Tablet
Andre navne:
  • MK-0616
  • enlicitide decanoat
Medicin: MK-7262
Oral Coated Tablet
Andre navne:
  • HRS-5346

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Efterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. juli 2026

Primær færdiggørelse (Anslået)

12. oktober 2027

Studieafslutning (Anslået)

12. oktober 2027

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7262-004
  • MK-7262-004 (Anden identifikator: MSD)
  • U1111-1333-1832 (Anden identifikator: UTN)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lipoprotein(a)

Kliniske forsøg med Placebo for MK-7262

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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