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

NCT07614984 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: 7262-004MK-7262-004U1111-1333-1832
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lipoprotein(a)

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline and Week 8

• 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.

  Baseline and Week 8

• 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.

  Up to approximately 20 Weeks

• 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.

  Up to approximately 12 Weeks

Secondary Outcomes (8)

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

  Baseline and Week 8

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

  Baseline and Week 8

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

  Baseline and Week 8

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

  Baseline and Week 8

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

  Week 8

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for MK-7262; Drug: Placebo for enlicitide

enlicitide monotherapy

ACTIVE COMPARATOR

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

Drug: Enlicitide; Drug: Placebo for MK-7262

MK-7262 monotherapy

EXPERIMENTAL

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

Drug: MK-7262; Drug: Placebo for enlicitide

MK-7262 + enlicitide

EXPERIMENTAL

Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.

Drug: MK-7262; Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral Coated Tablet

Also known as: MK-0616, enlicitide decanoate

MK-7262 + enlicitide; enlicitide monotherapy

Placebo for MK-7262 DRUG

Oral Coated Tablet

Placebo; enlicitide monotherapy

MK-7262 DRUG

Oral Coated Tablet

Also known as: HRS-5346

MK-7262 + enlicitide; MK-7262 monotherapy

Placebo for enlicitide DRUG

Oral Coated Tablet

MK-7262 monotherapy; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 7, 2026
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): October 12, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share