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Monoclonal Antibodies
MK-0616 for High Cholesterol
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
Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1
Is on a stable dose of all background LLTs for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first occurrence of 3-point mace, assessed up to approximately 6 years
Awards & highlights
Study Summary
This trial studies an oral drug to reduce risk of heart problems in people with high cardiovascular risk.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for MK-0616 aren't listed here, PCSK9 inhibitors can cause symptoms like flu-like illness, injection site reactions (though MK-0616 is oral), muscle pain, and possible neurocognitive events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking strong cholesterol medication.
Select...
I have been on the same dose of my long-term treatments for over 30 days.
Select...
I am over 18 and have had a major heart or blood vessel event.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first occurrence of 3-point mace, assessed up to approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first occurrence of 3-point mace, assessed up to approximately 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus
Secondary outcome measures
Number of Participants Discontinuing from Study Therapy Due to AE
Number of Participants with an Adverse Event (AE)
Percent Change from Baseline in Apolipoprotein B
+13 moreSide effects data
From 2022 Phase 2 trial • 381 Patients • NCT052611267%
Dyspepsia
5%
Arthralgia
4%
Fatigue
1%
Nausea
1%
Cholecystitis
1%
COVID-19
1%
Deep vein thrombosis
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
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 receive MK-0616 20 mg once daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-0616
2023
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,046,596 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,049,669 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration verified MK-0616 for use?
"Based on the data presented, MK-0616 has been awarded a 3 for safety due to the efficacy information and corroborative rounds of research that support its security."
Answered by AI
Are there any vacancies available for individuals to participate in this clinical trial?
"Evidenced by clinicaltrials.gov, this trial is still recruiting participants. The initial posting took place on October 9th 2023 and was last revised shortly after that date, being updated on the 15th of the same month."
Answered by AI
In how many health care facilities is this investigation being conducted?
"Patients can join this study at East Coast Institute for Research in Lake City, Florida, Clinical Site Partners LLC (dba CSP Orlando) in Winter Park, Georgia and North Georgia Clinical Research in Woodstock, Illinois. There are 17 other locations hosting the trial as well."
Answered by AI
How many volunteers are participating in this trial?
"In order to fulfill the predetermined criteria, this trial requires 14550 participants. Potential enrollees can go to East Coast Institute for Research (Site 0034) located in Lake City, Florida or Clinical Site Partners LLC, dba CSP Orlando (Site 0067) situated in Winter Park, Georgia."
Answered by AI
Who else is applying?
What site did they apply to?
East Coast Institute for Research ( Site 0034)
North Georgia Clinical Research ( Site 0128)
Excel Clinical Research, LLC ( Site 0123)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am interested in the clinical trials you are offering. I like to if there are other things that might help me in the future.
PatientReceived 2+ prior treatments
The medication I am taking is expensive and the results are not that great.
PatientReceived 1 prior treatment
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