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

NCT07614984
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
750
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2026-06-30
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Number of sites
31
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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
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Short title
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-10-12
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First posted
2026-05-29
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Registry last updated
2026-08-28
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Primary completion date
2027-10-12
clinicaltrials.gov
Start date
2026-06-30
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Participants
750
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Participant count basis
Estimated
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Planned participants
750
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Protocol amendments
0
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Number of sites
31
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07614984
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ClinicalTrials.gov ID
NCT07614984
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8

    Timeframe: 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).

  2. Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

    Timeframe: Baseline and Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.

  3. Number of Participants who Experience One or More Adverse Events (AEs)

    Timeframe: 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.

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

    Timeframe: 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.

  1. Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)

    Timeframe: 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.

  2. Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)

    Timeframe: 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.

  3. Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)

    Timeframe: 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.

  4. Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)

    Timeframe: 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.

  5. Percentage of Participants with Lp(a) <125 nmol/L at Week 8

    Timeframe: 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.

  6. Percentage of Participants with Lp(a) <75 nmol/L at Week 8

    Timeframe: 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.

  7. Percent Change from Baseline in Lp(a) at Week 12

    Timeframe: 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).

  8. Percent Change from Baseline in LDL-C at Week 12

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

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
Sources for eligibility
clinicaltrials.gov

  • Advanced Cardiovascular - Alexander City ( Site 0158)Alexander City, United StatesRecruiting
  • AMR Clinical Mobile ( Site 0149)Mobile, United StatesRecruiting
  • National Heart Institute ( Site 0113)Beverly Hills, United StatesRecruiting
  • Headlands Research CTR Lincoln ( Site 0127)Lincoln, United StatesRecruiting
  • Chase Medical Research, LLC ( Site 0163)Waterbury, United StatesRecruiting
  • Soffer Health Institute ( Site 0123)Hollywood, United StatesRecruiting
  • Westside Center for Clinical Research ( Site 0161)Jacksonville, United StatesRecruiting
  • Inpatient Research Clinic ( Site 0110)Miami Lakes, United StatesRecruiting
  • Clinical Research Trials of Florida ( Site 0101)Tampa, United StatesRecruiting
  • Conquest Research LLC ( Site 0140)Winter Park, United StatesRecruiting
  • Flourish Research - Bowie ( Site 0106)Bowie, United StatesRecruiting
  • Velocity Clinical Research Rockville ( Site 0146)Rockville, United StatesRecruiting
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)Troy, United StatesRecruiting
  • Minneapolis Heart Institute - Minneapolis ( Site 0130)Minneapolis, United StatesRecruiting
  • Montana Medical Research, Inc. ( Site 0156)Missoula, United StatesRecruiting
  • New Mexico Clinical Research & Osteoporosis Center ( Site 0119)Albuquerque, United StatesRecruiting
  • Laurelton Heart Specialist PC ( Site 0155)Rosedale, United StatesRecruiting
  • Velocity Clinical Research, Durham ( Site 0145)Durham, United StatesRecruiting
  • Remington-Davis, Inc. ( Site 0107)Columbus, United StatesRecruiting
  • Holston Medical Group ( Site 0117)Kingsport, United StatesRecruiting
  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)Houston, United StatesRecruiting
  • DM Clinical Research ( Site 0115)Tomball, United StatesRecruiting
  • Carient Heart & Vascular - Manassas ( Site 0165)Manassas, United StatesRecruiting
  • Rainier Clinical Research Center ( Site 0116)Renton, United StatesRecruiting
  • Medical Corporation Heishinkai OCROM Clinic ( Site 2403)Suita, JapanRecruiting

And 6 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-7262-004
  • 2025
  • U1111-1333-1832
  • jRCT2021260024
  • 2025-525102-38-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)