Your session is about to expire
← Back to Search
Oral PCSK9 Inhibitor for High Cholesterol
Study Summary
This trial will compare the effect of a single dose of a drug in people with varying degrees of kidney impairment to healthy controls.
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- You drink more than 3 alcoholic drinks per day.Your kidney function has been changing a lot based on past test results.You have taken a specific type of medication for high cholesterol within the past year.If you take medications for ongoing health issues or kidney problems, you need to have been on a consistent dose for at least 1 month (2 months for statins) before starting the study. You also need to be able to pause taking these medications for 4 hours before and after the study intervention.You need to be in good health except for having kidney problems and high cholesterol, unless these conditions are stable and you have other ongoing health issues like high blood pressure, diabetes, or anxiety.Your body mass index (BMI) is between 18 and 40.You have had a kidney transplant in the last 5 years and are taking medication for it.You have a history of stomach or intestine problems that could affect how your body absorbs food and medicine, or you have had stomach surgery like gastric bypass.You have had cancer in the past.You have a history or current condition of narrowing in the arteries leading to the kidneys.You drink more than 6 servings of caffeinated drinks every day.
- Group 1: Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
- Group 2: Panel D: Healthy
- Group 3: Panel B: Severe RI
- Group 4: Panel A: Moderate Renal Impairment (RI)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 the age eligibility for this experiment capped at 35 years old?
"This medical study is recruiting individuals aged 18 and older, but below 85 years of age."
Are new participants being welcomed for this experiment?
"As per the clinicaltrials.gov portal, this trial is currently enrolling patients. The study was first made available on July 20th of 2021 and has been modified most recently on July 26th of 2021."
What are the principal goals of this experiment?
"The central metric of this trial, which will be measured at intervals spanning from pre-treatment to 240 hours post-dose, is the Area Under Curve (AUC) for MK-0616. Additionally, we are also gauging Percentage of Participants Who Discontinue due to an Adverse Event (AE), Dialysate Clearance and Renal Clearance for MK-0616."
What adverse effects have been observed with Panel B: Severe RI?
"As this is a Phase 1 trial, with limited data to support safety and efficacy, Panel B: Severe RI was rated as having low-level security on the Power team's scale of 1-3."
What qualifications must potential participants possess to join this medical trial?
"This research protocol is recruiting 36 people aged 18 - 85 years old with high cholesterol as their primary condition. Eligible applicants must be in general good health, barring renal impairment and hypercholesterolemia for Panels A, B & C. Pre-existing chronic medical or psychiatric conditions such as hypertension, diabetes mellitus, thyroid disorders, gout and chronic anxiety/depression may be accepted at the discretion of the investigator and sponsor. Furthermore candidates should have a BMI within the range of 18 kg/m2 to 40 kg/m2 while also on a stable statin therapy dose (i.e no changes for 2 months before"
How many individuals are actively involved in this trial at the present moment?
"Affirmative. Clinicaltrials.gov provides evidence that this medical research is actively searching for individuals to participate in the study, which was first uploaded on July 20th 2023 and recently amended on July 26th 2023. A total of 36 participants are needed across 3 separate clinics."
Share this study with friends
Copy Link
Messenger