Obicetrapib for Cardiovascular Disease

(PREVAIL Trial)

Recruiting at 620 trial locations

Overseen By Andrea Flannery

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NewAmsterdam Pharma

Must be taking: Lipid-modifying therapy

Must not be taking: Gemfibrozil

Disqualifiers: Heart failure, MI, Stroke, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 months

9541 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on maximally tolerated lipid-lowering therapy. You cannot take gemfibrozil within 30 days before screening.

Research Team

Marc Ditmarsch, MD

Principal Investigator

NewAmsterdam Pharma

Eligibility Criteria

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.

Inclusion Criteria

I have heart or blood vessel disease.

Fasting LDL-C ≥ 55 mg/dL

I am on the highest dose of medication for my cholesterol that I can tolerate.

Exclusion Criteria

My heart's pumping ability is severely reduced.

I was hospitalized for heart failure in the last 5 years.

My blood pressure is not controlled by medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 10mg Obicetrapib or placebo once daily

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Obicetrapib
• Placebo

Trial Overview 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).

Participant Groups

Group I: obicetrapib 10mg Experimental Treatment 1 Intervention

one 10mg tablet, once daily.

Group II: Placebo Placebo Group 1 Intervention

one placebo tablet, once daily

Who Is Running the Clinical Trial?

NewAmsterdam Pharma

Lead Sponsor

Trials

17

Recruited

13,900+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+