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Lipoprotein(a)Phase 2NCT07614984

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

A Phase 2 study testing MK-7262 and Enlicitide in people with Lipoprotein(a), run by Merck Sharp & Dohme LLC at 76 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lipoprotein(a)
What is being tested?
MK-7262 and Enlicitide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
750 participants
Where
76 sitesin 9 countries
Study dates
30 Jun 2026to 12 Oct 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

76 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

76 sites in 9 countries

United States24 sites, 24 recruiting

  • New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

    Albuquerque, New Mexico, 87106

    Study Coordinator, 505-855-5505

    Recruiting

  • Advanced Cardiovascular - Alexander City ( Site 0158)

    Alexander City, Alabama, 35010

    Study Coordinator, 256-215-5323

    Recruiting

  • National Heart Institute ( Site 0113)

    Beverly Hills, California, 90211-2285

    Study Coordinator, 310-289-5221

    Recruiting

  • Flourish Research - Bowie ( Site 0106)

    Bowie, Maryland, 20715

    Study Coordinator, 410-824-1341

    Recruiting

  • Remington-Davis, Inc. ( Site 0107)

    Columbus, Ohio, 43215

    Study Coordinator, 614-487-2560

    Recruiting

  • Velocity Clinical Research, Durham ( Site 0145)

    Durham, North Carolina, 27701

    Study Coordinator, 919-503-4711

    Recruiting

  • Soffer Health Institute ( Site 0123)

    Hollywood, Florida, 33020

    Study Coordinator, 305-250-2106

    Recruiting

  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)

    Houston, Texas, 77030

    Study Coordinator, 713-798-5800

    Recruiting

  • Westside Center for Clinical Research ( Site 0161)

    Jacksonville, Florida, 32205

    Study Coordinator, 904-693-1490

    Recruiting

  • Holston Medical Group ( Site 0117)

    Kingsport, Tennessee, 37660

    Study Coordinator, 423-857-2789

    Recruiting

  • Headlands Research CTR Lincoln ( Site 0127)

    Lincoln, California, 95648

    Study Coordinator, 916-434-8230

    Recruiting

  • Carient Heart & Vascular - Manassas ( Site 0165)

    Manassas, Virginia, 20109

    Study Coordinator, 571-581-1771

    Recruiting

  • Inpatient Research Clinic ( Site 0110)

    Miami Lakes, Florida, 33014

    Study Coordinator, 786-502-4303

    Recruiting

  • Minneapolis Heart Institute - Minneapolis ( Site 0130)

    Minneapolis, Minnesota, 55407

    Study Coordinator, 612-863-3833

    Recruiting

  • Montana Medical Research, Inc. ( Site 0156)

    Missoula, Montana, 59808

    Study Coordinator, 406-549-1124

    Recruiting

  • AMR Clinical Mobile ( Site 0149)

    Mobile, Alabama, 36608

    Study Coordinator, 251-414-1984

    Recruiting

  • Rainier Clinical Research Center ( Site 0116)

    Renton, Washington, 98057

    Study Coordinator, 425-251-1720

    Recruiting

  • Velocity Clinical Research Rockville ( Site 0146)

    Rockville, Maryland, 20854

    Study Coordinator, 240-698-2800

    Recruiting

  • Laurelton Heart Specialist PC ( Site 0155)

    Rosedale, New York, 11422

    Study Coordinator, 718-949-9400

    Recruiting

  • Clinical Research Trials of Florida ( Site 0101)

    Tampa, Florida, 33607

    Study Coordinator, 813-873-8102

    Recruiting

  • DM Clinical Research ( Site 0115)

    Tomball, Texas, 77375

    Study Coordinator, 346-550-9559

    Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)

    Troy, Michigan, 48098

    Study Coordinator, 248-312-0025

    Recruiting

  • Chase Medical Research, LLC ( Site 0163)

    Waterbury, Connecticut, 06708

    Study Coordinator, 203-419-4420

    Recruiting

  • Conquest Research LLC ( Site 0140)

    Winter Park, Florida, 32789

    Study Coordinator, 407-916-0060

    Recruiting

Other trials in United States

Germany10 sites, 10 recruiting

  • zibp GmbH ( Site 0716)

    Berlin, 10439

    Study Coordinator, +4930233212880

    Recruiting

  • FutureMeds GmbH ( Site 0718)

    Berlin, 10629

    Study Coordinator, +4930439741610

    Recruiting

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)

    Berlin, 12203

    Study Coordinator, +493045061847

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden' ( Site 0713)

    Dresden, Saxony, 01307

    Study Coordinator, +4935145811722

    Recruiting

  • Hector-Center fuer Ernaehrung ( Site 0715)

    Erlangen, Bavaria, 91054

    Study Coordinator, +4991318545220

    Recruiting

  • Ambulantes Herzzentrum Kassel ( Site 0721)

    Kassel, Hesse, 34121

    Study Coordinator, +49561937690

    Recruiting

  • Klinikum Konstanz ( Site 0723)

    Konstanz, Baden-Wurttemberg, 78464

    Study Coordinator, +497538010

    Recruiting

  • Deutsches Herzzentrum Muenchen ( Site 0717)

    Munich, Bavaria, 80636

    Study Coordinator, +498912180

    Recruiting

  • Dedicated Research Site FutureMeds ( Site 0719)

    Offenbach, Hesse, 63065

    Study Coordinator, +4969247433849

    Recruiting

  • Studienzentrum Brinkum - Torsten Drescher & Dr. Lars Pohlmeier ( Site 0712)

    Stuhr, Lower Saxony, 28816

    Study Coordinator, +494218305310

    Recruiting

Other trials in Germany

Japan9 sites, 9 recruiting

  • Kumanomae Nishimura Naika Clinic ( Site 2407)

    Arakawa City, Tokyo, 116-0012

    Study Coordinator, +81-3-5855-7555

    Recruiting

  • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 2400)

    Fukuoka, 810-0001

    Study Coordinator, +81-92-738-3335

    Recruiting

  • Minamino Cardiovascular Hospital ( Site 2406)

    Hachiōji, Tokyo, 192-0918

    Study Coordinator, +81-42-637-8101

    Recruiting

  • Kato Clinic of Internal Medicine ( Site 2402)

    Katsushika-ku, Tokyo, 125-0054

    Study Coordinator, +81-3-5668-2161

    Recruiting

  • Swing Nozaki Clinic ( Site 2405)

    Musashino, Tokyo, 180-0022

    Study Coordinator, +81-422-36-3534

    Recruiting

  • Midori Clinic ( Site 2401)

    Nagasaki, 852-8034

    Study Coordinator, +81-95-844-7191

    Recruiting

  • National Hospital Organization Osaka National Hospital ( Site 2408)

    Osaka, 540-0006

    Study Coordinator, +81-6-6942-1331

    Recruiting

  • Medical Corporation Heishinkai ToCROM Clinic ( Site 2404)

    Shinjuku, Tokyo, 160-0008

    Study Coordinator, +81-3-5366-5333

    Recruiting

  • Medical Corporation Heishinkai OCROM Clinic ( Site 2403)

    Suita, Osaka, 565-0853

    Study Coordinator, +81-6-6330-8810

    Recruiting

Other trials in Japan

Spain9 sites, 9 recruiting

  • Hospital San Rafael - La Coruña ( Site 1402)

    A Coruña, La Coruna, 15006

    Study Coordinator, +34655624017

    Recruiting

  • Hospital Universitari Vall d Hebron ( Site 1403)

    Barcelona, 08035

    Study Coordinator, +34934896134

    Recruiting

  • Hospital Clinic de Barcelona ( Site 1419)

    Barcelona, 08036

    Study Coordinator, 932279846

    Recruiting

  • Vithas Hospital Sevilla ( Site 1401)

    Castilleja de la Cuesta, Sevilla, 41950

    Study Coordinator, +34658011529

    Recruiting

  • Hospital Viamed Santa Elena ( Site 1422)

    Madrid, 28003

    Study Coordinator, +34621151370

    Recruiting

  • Hospital Universitario La Paz ( Site 1405)

    Madrid, 28046

    Study Coordinator, +34912071427

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca ( Site 1406)

    Murcia, 30120

    Study Coordinator, +34968381027

    Recruiting

  • Hospital Universitario Nuestra Senora de Valme ( Site 1415)

    Seville, Andalusia, 41014

    Study Coordinator, +34955015878

    Recruiting

  • Nuevas Tecnologías en D y E - Sevillaocío ( Site 1412)

    Seville, 41003

    Study Coordinator, +34656193053

    Recruiting

Other trials in Spain

Netherlands7 sites, 7 recruiting

  • Noordwest Ziekenhuisgroep ( Site 1110)

    Alkmaar, North Holland, 1815 JD

    Study Coordinator, +31725484495

    Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk ( Site 1101)

    Dordrecht, South Holland, 3318 AT

    Study Coordinator, +31786523366

    Recruiting

  • Ziekenhuis Gelderse Vallei ( Site 1106)

    Ede, Gelderland, 6716 RP

    Study Coordinator, +31318435855

    Recruiting

  • Martini Ziekenhuis ( Site 1108)

    Groningen, 9728 NT

    Study Coordinator, 31505245641

    Recruiting

  • Ziekenhuis St. Jansdal ( Site 1113)

    Harderwijk, Gelderland, 3844 DG

    Study Coordinator, +310341463883

    Recruiting

  • Bravis Ziekenhuis, locatie Roosendaal ( Site 1102)

    Roosendaal, North Brabant, 4708 AE

    Study Coordinator, 31887068000

    Recruiting

  • Antonius Ziekenhuis, locatie D&A Research and Genetics ( Site 1103)

    Sneek, Provincie Friesland, 8601 ZR

    Study Coordinator, 0515-434275

    Recruiting

Other trials in Netherlands

Switzerland5 sites, 5 recruiting

  • University Hospital Basel ( Site 1701)

    Basel, Canton of Basel-City, 4031

    Study Coordinator, +41613287482

    Recruiting

  • Hopitaux Universitaires (Geneve) ( Site 1704)

    Geneva, 1211

    Study Coordinator, +41223727192

    Recruiting

  • Luzerner Kantonsspital ( Site 1702)

    Lucerne, 6000

    Study Coordinator, +41412055000

    Recruiting

  • Istituto Cardiocentro Ticino - Ente Ospedaliero Cantonale ( Site 1705)

    Lugano, Canton Ticino, 6900

    Study Coordinator, +41 91 8115055

    Recruiting

  • HOCH Health Ostschweiz ( Site 1703)

    Sankt Gallen, Canton of St. Gallen, 9007

    Study Coordinator, 41714941228

    Recruiting

Other trials in Switzerland

Canada4 sites, 4 recruiting

  • Ecogene-21 ( Site 0202)

    Chicoutimi, Quebec, G7H 7K9

    Study Coordinator, 418-545-1252

    Recruiting

  • North York Diagnostic and Cardiac Centre ( Site 0203)

    North York, Ontario, M6B 3H7

    Study Coordinator, 416-783-0000

    Recruiting

  • Clinique des Maladies Lipidiques de Quebec ( Site 0201)

    Québec, Quebec, G1V 4W2

    Study Coordinator, 418-780-1376

    Recruiting

  • Diex Recherche Trois-Rivieres ( Site 0204)

    Trois-Rivières, Quebec, G9A 4P3

    Study Coordinator, 819-801-9797

    Recruiting

Other trials in Canada

Colombia4 sites, 4 recruiting

  • Clinica de la Costa S.A.S ( Site 0404)

    Barranquilla, Atlántico, 80020

    Study Coordinator, +57 3128335766

    Recruiting

  • Solano & Terront Servicios Medicos - UNIENDO SAS ( Site 0402)

    Bogota, Cundinamarca, 110221

    Study Coordinator, +573016831697

    Recruiting

  • Salud SURA Industriales ( Site 0405)

    Medellín, Antioquia, 05001

    Study Coordinator, +573193374390

    Recruiting

  • IMAT S.A.S ( Site 0400)

    Montería, Departamento de Córdoba, 23001

    Study Coordinator, +57 3017057680

    Recruiting

Other trials in Colombia

Denmark4 sites, 4 recruiting

  • Esbjerg sygehus, Syddansk Universitetshospital ( Site 0505)

    Esbjerg, Region Syddanmark, 6700

    Study Coordinator, 004579182268

    Recruiting

  • Sanos Clinic - Nordjylland ( Site 0502)

    Gandrup, North Denmark, 9362

    Study Coordinator, +45 73708220

    Recruiting

  • OUH Svendborg Sygehus ( Site 0500)

    Svendborg, Region Syddanmark, 5700

    Study Coordinator, +4563202000

    Recruiting

  • Regionshospitalet Viborg ( Site 0507)

    Viborg, Central Jutland, 8800

    Study Coordinator, +4521269495

    Recruiting

Other trials in Denmark

About this study

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)

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
Conditions
Lipoprotein(a)
Being tested
MK-7262, Enlicitide, Placebo for MK-7262, Placebo for enlicitide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-7262Drug

    Also called HRS-5346

    Oral Coated Tablet

  • EnlicitideDrug

    Also called MK-0616, enlicitide decanoate

    Oral Coated Tablet

  • Placebo for MK-7262Drug

    Oral Coated Tablet

  • Placebo for enlicitideDrug

    Oral Coated Tablet

Study groups in NCT07614984
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Receives: Drug: Placebo for MK-7262; Drug: Placebo for enlicitide
enlicitide monotherapyActive comparatorParticipants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Receives: Drug: Enlicitide; Drug: Placebo for MK-7262
MK-7262 monotherapyExperimentalParticipants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Receives: Drug: MK-7262; Drug: Placebo for enlicitide
MK-7262 + enlicitideExperimentalParticipants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.
Receives: Drug: MK-7262; Drug: Enlicitide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and Week 8

  2. 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.

    Measured: Baseline and Week 8

  3. 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.

    Measured: Up to approximately 20 Weeks

  4. Number of Participants Who Discontinue Study Intervention Due to an AE

    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.

    Measured: Up to approximately 12 Weeks

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and Week 8

  2. 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.

    Measured: Baseline and Week 8

  3. 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.

    Measured: Baseline and Week 8

  4. 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.

    Measured: Baseline and Week 8

  5. 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.

    Measured: Week 8

  6. 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.

    Measured: Week 8

  7. 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).

    Measured: Baseline and Week 12

  8. 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.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start30 Jun 2026
  3. Primary completion12 Oct 2027 (estimated)
  4. Study completion12 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614984
Sponsor's protocol ID
7262-004
Other IDs
MK-7262-004, U1111-1333-1832, 2025-525102-38-00, jRCT2021260024, 2025
Status last verified
Oct 2026
First submitted
22 May 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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