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Monoclonal Antibodies

MK-0616 for High Cholesterol

Q: Could you elaborate on the pivotal aims of this research project?

<p>According to Merck Sharp &#x26; Dohme LLC, the primary objective of this trial will be measured over a Baseline and Week 24 timeframe. This involves tracking the amount of participants who experience one or more adverse events (AEs). Furthermore, secondary outcomes such as mean percent change from baseline in non-HDL-C at Week 24 and mean percent change from baseline in ApoB at Week 24 shall also be examined. Lastly, the trial sponsor plans on evaluating the percentage change from baseline in lipoprotein(a) (Lp[a]) at Week 24 through blood samples collected during both Baseline and Week 24 time</p>

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~60 weeks

Awards & highlights

Study Summary

This trial tests a drug to lower cholesterol in adults with high cholesterol. Results will measure if it's better than placebo. #cholesterol #clinicaltrial

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Nausea

Cholecystitis

COVID-19

Deep vein thrombosis

Diarrhoea

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-0616Experimental Treatment1 Intervention

Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-0616

2023

Completed Phase 2

~440

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,058,386 Total Patients Enrolled

5 Trials studying High Cholesterol

14,762 Patients Enrolled for High Cholesterol

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,061,644 Total Patients Enrolled

2 Trials studying High Cholesterol

14,583 Patients Enrolled for High Cholesterol

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects have been associated with MK-0616?

"Our experts at Power gave MK-0616 a 3 due to the existence of evidence for its efficacy and safety as it has gone through numerous trials in Phase 3."

Answered by AI

How many geographic areas are offering this research opportunity?

"Presently, there are 41 locations around the USA that are hosting this medical trial. These sites include Phoenix, Banning and Sacramento in addition to 38 other spots. To reduce travel needs it is best if you pick a clinic close by when enrolling."

Answered by AI

Are participants being accepted to join this research endeavor?

"Affirmative. Information on clinicaltrials.gov indicates that this study, which was first published on August 10th 2023, is currently recruiting patients. In total, 2760 participants must be enrolled from 41 separate research centres."

Answered by AI

How many individuals have been accepted to participate in this trial?

"Indeed, the data referenced on clinicaltrials.gov supports that this trial is actively enlisting patients. This medical experiment was first announced on August 10th 2023 and has been updated most recently as of August 28th 2023. The study requires 2,760 volunteers to be sourced from 41 distinct sites."

Answered by AI

Could you elaborate on the pivotal aims of this research project?

"According to Merck Sharp & Dohme LLC, the primary objective of this trial will be measured over a Baseline and Week 24 timeframe. This involves tracking the amount of participants who experience one or more adverse events (AEs). Furthermore, secondary outcomes such as mean percent change from baseline in non-HDL-C at Week 24 and mean percent change from baseline in ApoB at Week 24 shall also be examined. Lastly, the trial sponsor plans on evaluating the percentage change from baseline in lipoprotein(a) (Lp[a]) at Week 24 through blood samples collected during both Baseline and Week 24 time"

Answered by AI

Who else is applying?

What site did they apply to?

Clinical Research Trials of Florida ( Site 0063)

Rainier Clinical Research Center ( Site 0116)

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I am a 34-year-old woman with hypercholesteremia. I am health conscious and follow a healthy diet. I exercise regularly, at least 6 days a week. I am 5'5 and 140lbs. I do not smoke or drink alcohol nor do I take any drugs. I get plenty of sleep and live an active lifestyle. My most recent lipid panel performed this past week has my total cholesterol at 452. My LDL is very high as well. My HDL has always been between 55-68. I have tried rosuvastatin in the past, but I did not like the way I felt as I connected sleep disturbances as well as ongoing muscle pain to the drug while taking.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

2023. "A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952856.

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