MK-0616 for High Cholesterol

Recruiting at 678 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Statins

Must not be taking: PCSK9 inhibitors

Disqualifiers: Heart failure, Ventricular tachycardia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 years

14550 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing MK-0616, a pill, in people with high cardiovascular risk. The goal is to see if it can prevent serious heart-related events by lowering bad cholesterol.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current cholesterol-lowering medications, including statins, for at least 30 days before starting and throughout the study. No changes to your medication or dose are planned during the trial.

What data supports the effectiveness of the drug MK-0616 for high cholesterol?

The research highlights the benefits of lowering LDL cholesterol (bad cholesterol) and raising HDL cholesterol (good cholesterol) to reduce the risk of heart disease. While specific data on MK-0616 is not provided, similar treatments like statins and fibrates have shown effectiveness in managing cholesterol levels and reducing cardiovascular events. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults at high risk of a major cardiovascular event who have had one before. They must be on stable cholesterol-lowering meds, including statins, and not planning changes during the study. People with very high triglycerides, recent severe heart issues, certain genetic cholesterol disorders, or severe kidney disease can't join.

Inclusion Criteria

I am currently taking strong cholesterol medication.

I have been on the same dose of my long-term treatments for over 30 days.

I am over 18 and have had a major heart or blood vessel event.

Exclusion Criteria

I have a genetic condition that causes very high cholesterol.

I have taken or am taking certain cholesterol medications without a break.

I have severe kidney problems or am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enlicitide decanoate 20 mg or placebo once daily

Up to 6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MK-0616

Trial Overview The study tests MK-0616, an oral drug aiming to prevent major heart-related events by inhibiting PCSK9 versus a placebo. Participants are randomly assigned to either receive MK-0616 or a placebo to see if it extends the time until another serious heart issue occurs.

Participant Groups

Group I: Enlicitide Decanoate Experimental Treatment 1 Intervention

Participants receive enlicitide decanoate 20 mg once daily.

Group II: Placebo Placebo Group 1 Intervention

Participants receive placebo once daily.

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

Findings from Research

Raising high-density lipoprotein cholesterol (HDLC) in patients with low levels is considered in high-risk individuals, such as those with established heart disease or diabetes, but there is still uncertainty about the benefits of HDL-raising therapies due to a lack of event-based trials.

In high-risk patients, statins are typically used to lower low-density lipoprotein cholesterol (LDLC), and additional medications like niacin or fibrates may be added to effectively raise HDLC levels, although specific HDLC targets are not formally established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Drug Options for Raising HDL Cholesterol. Dunbar, RL., Rader, DJ.[2020]

Fenofibrate therapy in a study of 9795 patients showed an 11% reduction in coronary events, particularly benefiting primary prevention and nonfatal myocardial events, although the results were confounded by statin use.

Fenofibrate demonstrated good safety profiles, even when combined with statins, but raised old concerns about risks like sudden death and pancreatitis; it also showed unexpected benefits in reducing microvascular complications such as microalbuminuria and retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FIELDS of dreams, fields of tears: a perspective on the fibrate trials. Wierzbicki, AS.[2013]

New drug therapies targeting multiple cardiometabolic risk factors for metabolic syndrome have shown promise, including agents that improve HDL cholesterol levels and glucose metabolism, which are crucial for reducing coronary heart disease risk.

Clinical trials indicate that therapies like cholesteryl ester transfer protein inhibitors and glitazars not only enhance lipid profiles but also address abnormal glucose metabolism, highlighting their potential in comprehensive cardiovascular risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and emerging strategies for reducing cardiometabolic risk factors. Rodgers, PT., Fuke, DC.[2017]

Dietary therapy is the first line of treatment for dyslipidaemia, and lipid-lowering medications are recommended for patients who do not respond adequately to diet, especially those with coronary heart disease (CHD) or multiple risk factors.

Statins are highlighted for their antiatherosclerotic properties, making them a key choice among various lipid-lowering drugs, which also include anion-exchange resins, fibrates, and newer experimental classes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacologic treatment of lipid metabolism disorders]. Gmiński, J.[2010]

Intensive reduction of low-density lipoprotein cholesterol (LDL-C) is crucial for lowering the risk of coronary heart disease (CHD), with new guidelines suggesting targets of 2 mmol/L for LDL-C, which may lead to better treatment outcomes for patients.

Statins, particularly rosuvastatin, have shown significant efficacy in reducing LDL-C levels (up to 55%) and improving clinical outcomes in high-risk patients, while ongoing studies aim to further clarify the optimal LDL-C levels for risk reduction and the importance of raising high-density lipoprotein cholesterol (HDL-C) as a therapeutic target.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical lipid-regulating therapy: current evidence, ongoing trials and future developments. Evans, M., Roberts, A., Davies, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Current Drug Options for Raising HDL Cholesterol. [2020]

2. India pubmed.ncbi.nlm.nih.gov

FIELDS of dreams, fields of tears: a perspective on the fibrate trials. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

New and emerging strategies for reducing cardiometabolic risk factors. [2017]

4. Poland pubmed.ncbi.nlm.nih.gov

[Pharmacologic treatment of lipid metabolism disorders]. [2010]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Medical lipid-regulating therapy: current evidence, ongoing trials and future developments. [2022]