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Cholesteryl Ester Transfer Protein (CETP) Inhibitor
Obicetrapib for Cardiovascular Disease (PREVAIL Trial)
Phase 3
Waitlist Available
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months after last participant randomized
Awards & highlights
Summary
This trial is testing a new medication called Obicetrapib to help people with heart disease who still have high cholesterol despite taking strong treatments. The goal is to see if this medication can lower their risk of heart attacks, strokes, and other serious heart problems by reducing bad cholesterol levels.
Who is the study for?
This trial is for adults with cardiovascular disease who are already on the highest dose of cholesterol-lowering meds they can handle, but still have high LDL (bad) cholesterol. They should not be in advanced heart failure, have had recent serious heart events or cancer treatments, uncontrolled blood pressure, severe liver issues, or a history of substance abuse.
What is being tested?
The study tests Obicetrapib against a placebo to see if it's better at managing cardiovascular risks when added to standard therapy. Participants won't know which one they're getting as it's randomly decided and kept secret even from the doctors (double-blind).
What are the potential side effects?
While specific side effects for Obicetrapib aren't listed here, common ones for drugs like this include headache, muscle pain, digestive problems, and possible liver enzyme changes. Side effects vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months after last participant randomized
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months after last participant randomized
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major Adverse Cardiovascular Effect (MACE)
Side effects data
From 2021 Phase 2 trial • 120 Patients • NCT047536063%
Tendonitis
3%
Inflammation
3%
Glaucoma
3%
Arthralgia
3%
Arthropod sting
3%
Lumbar spinal stenosis
3%
Somnolence
3%
Temporomandibular joint syndrome
3%
Renal impairment
3%
Headache
3%
Cardiomegaly
3%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Obicetrapib 10 mg
Obicetrapib 5 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: obicetrapib 10mgExperimental Treatment1 Intervention
one 10mg tablet, once daily.
Group II: PlaceboPlacebo Group1 Intervention
one placebo tablet, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
Not yet FDA approved
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 Cardiovascular Disease (CVD) often focus on lowering low-density lipoprotein cholesterol (LDL-C) due to its significant role in atherosclerosis. Statins, the most widely used lipid-lowering drugs, inhibit HMG-CoA reductase, an enzyme crucial for cholesterol synthesis in the liver, thereby reducing LDL-C levels.
PCSK9 inhibitors, such as alirocumab and evolocumab, work by inhibiting the PCSK9 protein, which leads to increased recycling of LDL receptors and enhanced clearance of LDL-C from the bloodstream. These treatments are vital for CVD patients as they help reduce the risk of adverse cardiovascular events like myocardial infarction and stroke by managing cholesterol levels and slowing the progression of atherosclerosis.
Find a Location
Who is running the clinical trial?
Monash UniversityOTHER
195 Previous Clinical Trials
10,580,241 Total Patients Enrolled
NewAmsterdam PharmaLead Sponsor
16 Previous Clinical Trials
4,359 Total Patients Enrolled
Marc Ditmarsch, MDStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is severely reduced.I was hospitalized for heart failure in the last 5 years.I am 18 years old or older.My blood pressure is not controlled by medication.I have heart or blood vessel disease.I have been diagnosed with homozygous familial hypercholesterolemia.I have an ongoing liver condition.I have not taken gemfibrozil in the last 30 days.I had cancer surgery within the last 3 years.I am on the highest dose of medication for my cholesterol that I can tolerate.My kidney function is good, with a filtration rate of at least 30 mL/min.I haven't had a heart attack, stroke, or major heart procedure in the last 3 months.I have a brain blood vessel condition.I am 18 years old or older.Your cholesterol is too high when you haven't eaten for a while.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: obicetrapib 10mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT05202509 — Phase 3
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