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Oral PCSK9 Inhibitor for High Cholesterol
Study Summary
This trial tests if a drug called MK-0616 can reduce cholesterol levels in people with an inherited form of high cholesterol.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 381 Patients • NCT05261126Trial Design
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Who is running the clinical trial?
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- Your LDL cholesterol level is higher than 55 mg/dL or 70 mg/dL, depending on your medical history.I was hospitalized for heart failure or have a history of it within the last 3 months.I am part of, or plan to join, an LDL cholesterol reduction program.I have been treated with cholesterol-lowering drugs, including PCSK9 inhibitors.I have been diagnosed with a type of high cholesterol that runs in families.I am on a consistent dose of my cholesterol medications with no changes expected.I have a genetic condition that causes very high cholesterol.I am currently taking a strong cholesterol-lowering medication.
- Group 1: MK-0616
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is MK-0616 safe to consume for human consumption?
"The safety profile of MK-0616 was rated at 3 due to the multiple rounds of data collected during Phase 3 trials, which suggest that this drug is both efficacious and safe."
Are there multiple sites where this research is being conducted?
"Currently, this medical trial has 4 sites where patients can be recruited. These locations are in Lincoln, Las Vegas and West Jordan as well as 4 others. Those interested should pick the nearest clinic to reduce commuting demands if enrolled."
How many participants are currently included in this research?
"Merck Sharp & Dohme LLC, the sponsor of this trial, requires 270 eligible participants to commence operations. This clinical research is set to be conducted at Velocity Clinical Research at The Pioneer Heart Institute in Lincoln, Nebraska as well as Jubilee Clinical Research in Las Vegas, Nevada."
Are there any openings for participation in this trial?
"Affirmative. The clinicaltrial.gov database shows that the research, initially posted on August 8th 2023 is currently recruiting participants. Currently, 270 people need to be recruited from 4 different sites for this experiment."
What are the core goals of this medical research?
"The trial sponsor, Merck Sharp & Dohme LLC, has stated that the primary outcome of this study will be evaluated over a Baseline and Week 24 period. This involves measuring how many patients experience adverse events (AEs). Further assessments are being conducted to determine the Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24, Percentage of participants with LDL-C lower than 70 mg/dL and ≥50% reduction from baseline at week 24, as well as Percent change from baseline in lipoprotein(a) (Lp[a]) at week 24."
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