MK-0616 for High Cholesterol

Recruiting in Palo Alto (17 mi)

+176 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called MK-0616 to see if it can lower bad cholesterol levels in adults with high cholesterol. The study will compare the effects of MK-0616 over several months. The goal is to find out if MK-0616 is safe, effective, and well-tolerated.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Adults with high cholesterol are eligible, especially those on stable cholesterol-lowering treatments, with a history of heart issues or at risk for them. LDL-C levels must meet specific criteria. People can't join if they have certain genetic cholesterol disorders, recent heart failure, LDL-C apheresis treatment without proper washout period, or use of some other cholesterol medications.

Inclusion Criteria

I am on a strong statin, have a statin intolerance, or can't take statins.

I am on a stable dose of medication for cholesterol with no changes expected.

I have had a major heart-related event and my bad cholesterol is 55 or higher, or I am at high risk for such an event and my bad cholesterol is 70 or higher.

Exclusion Criteria

I have been hospitalized for heart failure in the last 3 months.

I have taken certain cholesterol medications without a break before starting this trial.

I have a genetic condition that causes very high cholesterol.

Treatment Details

Interventions

• MK-0616 (Monoclonal Antibodies)

Trial Overview The study is testing MK-0616 against a placebo to see if it's better at lowering bad cholesterol (LDL-C) after 24 weeks. Participants will be randomly assigned to either the new oral medication group or the placebo group.

Participant Groups

Group I: Enlicitide Decanoate Experimental Treatment 1 Intervention

Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

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