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

NCTNCT07614984Other id7262-004Other idMK-7262-004Other idU1111-1333-1832Other id2025-525102-38-00

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 2
Enrollment: 750 participants (estimated)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Triple masking
Countries: 9 countries
United States, Canada, Colombia, Denmark, Germany, Japan, Netherlands, Spain, Switzerland
Start: 30 Jun 2026
Primary completion: 12 Oct 2027 (estimated)
Completion: 12 Oct 2027 (estimated)
First posted: 29 May 2026
Last update posted: 23 Oct 2026
Conditions: Lipoprotein(a)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 2
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
NCT07614984
30 Jun 2026 to est. 12 Oct 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

MK-7262Drug
EnlicitideDrug
Placebo for MK-7262Drug
Placebo for enlicitideDrug

Arms4

Placebo comparator
Placebo
Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Active comparator
enlicitide monotherapy
Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Experimental
MK-7262 monotherapy
Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.
Experimental
MK-7262 + enlicitide
Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.

Primary outcomes4

Outcomes the sponsor listed as primary.

Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8
Time frame · Baseline and Week 8
Registry description
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
Time frame · Baseline and Week 8
Registry description
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)
Time frame · Up to approximately 20 Weeks
Registry description
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
Time frame · Up to approximately 12 Weeks
Registry description
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.

Secondary outcomes(8)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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