750 Participants NeededMy employer runs this trial

MK-7262 + Enlicitide for High Lipoprotein(a)

Recruiting at 54 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Statins
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with high levels of lipoprotein(a) in their blood (at least 150 nmol/L) who have been taking a stable dose of statin medication for at least 30 days and do not plan to change this during the study.

Inclusion Criteria

Has Lp(a) ≥ 150 nmol/L
I have been on the same statin dose for at least 30 days with no planned changes.

Exclusion Criteria

I have HIV, but it is controlled with an undetectable viral load.
Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH
I have a history of severe heart problems or recent serious heart or blood vessel events.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-7262 and/or enlicitide or placebo orally once daily for up to approximately 12 weeks

12 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Bi-weekly visits

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests if MK-7262 alone or combined with enlicitide lowers harmful blood fats better than placebo. Participants are randomly assigned to get either one or both medicines, or placebos, to compare effects on cholesterol and safety.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MK-7262 monotherapyExperimental Treatment2 Interventions
Group II: MK-7262 + enlicitideExperimental Treatment2 Interventions
Group III: enlicitide monotherapyActive Control2 Interventions
Group IV: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University