What side effects are associated with this type of intervention?

Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors like alirocumab and evolocumab. Statins can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Ezetimibe is generally well-tolerated but can cause gastrointestinal issues and muscle pain. PCSK9 inhibitors, which are similar to MK-0616, have side effects such as injection site reactions, mild neurocognitive symptoms, and hypersensitivity reactions. Serious adverse effects are uncommon, and muscle toxicity is not typically observed with PCSK9 inhibitors.

What prior FDA approvals exist?

The FDA has approved several lipid-lowering agents for the treatment of high cholesterol, particularly PCSK9 inhibitors such as alirocumab and evolocumab. These drugs have been shown to effectively lower LDL-C levels and are often used in combination with statins and ezetimibe for patients who do not achieve their LDL-C goals with statins alone. Alirocumab and evolocumab are injectable medications that have demonstrated significant reductions in LDL-C and cardiovascular events in clinical trials. These treatments are similar to MK-0616, an oral PCSK9 inhibitor currently being studied for its efficacy, safety, and tolerability in adults with hypercholesterolemia.

What other types of research exist?

Promising novel alternatives to MK-0616 for high cholesterol patients include inclisiran, an injectable PCSK9 inhibitor that has shown significant LDL-C reduction with a favorable safety profile. Another alternative is pitavastatin, a potent HMG-CoA reductase inhibitor that reduces LDL cholesterol and triglycerides without significant drug interactions. Additionally, oral PCSK9 inhibitors are under development and may become viable options in the near future.

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Monoclonal Antibodies

MK-0616 for High Cholesterol

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL

Be older than 18 years old

Must not have

Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~60 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects for PCSK9 inhibitors like MK-0616 may include symptoms like injection site reactions (not applicable in this case as MK-0616 is oral), flu-like symptoms, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have a genetic condition that causes very high cholesterol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~60 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24

Number of participants who discontinue study drug due to an AE

Number of participants with one or more adverse events (AEs)

Secondary study objectives

Mean percent change from baseline in LDL-C at Week 52

Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24

Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24

+3 more

Side effects data

From 2022 Phase 2 trial • 381 Patients • NCT05261126

Dyspepsia

Arthralgia

Fatigue

COVID-19

Nausea

Cholecystitis

Diarrhoea

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

MK-0616 12 mg

MK-0616 18 mg

MK-0616 30 mg

Placebo

MK-0616 6 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Enlicitide DecanoateExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enlicitide Decanoate

2024

Completed Phase 2

~450

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors. Statins work by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis in the liver, leading to reduced LDL-C levels. Ezetimibe reduces cholesterol absorption in the intestines, further lowering LDL-C. PCSK9 inhibitors, such as the investigational oral agent MK-0616, increase the number of LDL receptors on liver cells, enhancing the clearance of LDL-C from the bloodstream. These treatments are crucial for high cholesterol patients as they significantly reduce the risk of cardiovascular events by lowering LDL-C levels.