2760 Participants Needed

MK-0616 for High Cholesterol

Recruiting at 176 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Statins
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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?

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.

Will I have to stop taking my current medications?

The trial requires that if you are on any lipid-lowering therapies (medications to lower cholesterol), you should be on a stable dose with no planned changes. If you are taking certain cholesterol-lowering medications like PCSK9 inhibitors, there needs to be an adequate washout period (time without taking these medications) before joining the trial.

What makes the drug MK-0616 unique for treating high cholesterol?

The drug MK-0616, also known as Enlicitide, is unique because it represents a novel approach to lowering cholesterol, potentially offering an alternative to traditional statins and other existing treatments like PCSK9 inhibitors. While specific details about its mechanism or administration are not provided, its development suggests it may offer new benefits or options for patients who do not respond well to current therapies.12345

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

The research suggests that lowering LDL cholesterol (bad cholesterol) is beneficial for reducing the risk of heart disease, and drugs like statins are commonly used for this purpose. While specific data on MK-0616 is not provided, similar treatments that lower LDL cholesterol have shown significant benefits in reducing cardiovascular events.678910

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enlicitide decanoate or placebo orally once daily for up to 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MK-0616
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Enlicitide DecanoateExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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

Published Research Related to This Trial

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

Citations

Current Drug Options for Raising HDL Cholesterol. [2020]
FIELDS of dreams, fields of tears: a perspective on the fibrate trials. [2013]
New and emerging strategies for reducing cardiometabolic risk factors. [2017]
[Pharmacologic treatment of lipid metabolism disorders]. [2010]
Medical lipid-regulating therapy: current evidence, ongoing trials and future developments. [2022]
Lipid-lowering therapy: Guidelines to precision medicine. [2022]
A new statin: a new standard. [2023]
Cerivastatin in primary hyperlipidemia--a multicenter analysis of efficacy and safety. [2019]
Update on dyslipidemia. [2007]
Ezetimibe. [2022]
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