Obicetrapib for Cardiovascular Disease

(PREVAIL Trial)

Not currently recruiting at 684 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called obicetrapib for individuals with Atherosclerotic Cardiovascular Disease (ASCVD) who continue to have high cholesterol levels despite using the strongest cholesterol-lowering medications. The study aims to determine if obicetrapib can further reduce cholesterol levels and improve heart health. Participants will receive either obicetrapib or a placebo (a non-active pill) once a day. This trial targets those with ASCVD who are on maximum cholesterol-lowering treatments yet still have high LDL cholesterol levels. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that obicetrapib is generally safe for patients. In one study, 4.3% of patients taking obicetrapib reported side effects, compared to 6.8% of those taking a placebo (a non-active pill used for comparison). Additionally, obicetrapib has shown promise in lowering bad cholesterol in patients at high risk for heart problems. While no treatment is without risks, current evidence suggests that obicetrapib is safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Obicetrapib is unique because it targets a protein called CETP (cholesteryl ester transfer protein) to lower LDL cholesterol, which is different from the usual approaches like statins that inhibit cholesterol production in the liver. Researchers are excited because CETP inhibitors have the potential to significantly reduce cardiovascular risk by altering cholesterol transport and metabolism. This novel mechanism could offer an alternative for patients who can't tolerate current treatments or need additional options to manage their cardiovascular health.

What evidence suggests that obicetrapib might be an effective treatment for cardiovascular disease?

Research has shown that obicetrapib can lower the risk of heart problems in people with a type of heart disease called ASCVD. One study found that participants taking obicetrapib experienced fewer heart-related deaths, heart attacks, or procedures to open blocked arteries compared to those not taking it (3.2% vs 4.7%), reducing these risks by about 32%. Obicetrapib also lowered bad cholesterol (LDL-C) and raised good cholesterol (HDL-C), both crucial for heart health. While researchers continue to study its safety and full effects, early results appear promising for those needing additional heart health support, even when on other treatments. Participants in this trial will receive either obicetrapib or a placebo to further evaluate its effectiveness and safety. ^{1 3 6 7 8}

Who Is on the Research Team?

Marc Ditmarsch, MD

Principal Investigator

NewAmsterdam Pharma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.07.056

Impact of Obicetrapib on Major Adverse Cardiovascular ... The rate of coronary heart disease death, myocardial infarction, or coronary revascularization was lower with obicetrapib (3.2% vs 4.7%; HR: 0.68; 95% CI: 0.46- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725073838

Impact of Obicetrapib on Major Adverse Cardiovascular ... The rate of coronary heart disease death, myocardial infarction, or coronary revascularization was lower with obicetrapib (3.2% vs 4.7%; HR: ...

3. jwatch.org jwatch.org/na59194/2025/09/19/obicetrapib-and-cardiovascular-outcomes-early-insights

Obicetrapib and Cardiovascular Outcomes: Early Insights Compared with placebo, obicetrapib showed greater reductions in LDL-C and increases in HDL-C at 1 year. Patients who received obicetrapib ...

4. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2415820

Safety and Efficacy of Obicetrapib in Patients at High ... The efficacy and safety of obicetrapib have not been fully characterized among patients at high risk for cardiovascular events. Methods. We ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40337982/

Safety and Efficacy of Obicetrapib in Patients at High ... The efficacy and safety of obicetrapib have not been fully characterized among patients at high risk for cardiovascular events. Methods: We ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528909/

Efficacy and safety of obicetrapib in patients with dyslipidemia Among patients with dyslipidemia and/or at high cardiovascular risk, obicetrapib significantly reduced LDL-C, Lp(a), apoB, and non-HDL-C ...

7. ir.newamsterdampharma.com ir.newamsterdampharma.com/news-releases/news-release-details/newamsterdam-pharma-announces-positive-topline-data-pivotal-1

Press Release Details The Company's Phase 3 BROADWAY clinical trial (NCT05142722) evaluating obicetrapib in adult patients with established atherosclerotic cardiovascular disease.

8. menarini.com menarini.com/en-us/news/news-detail/menarini-announces-positive-topline-data-from-pivotal-phase-3-brooklyn-clinical-trial-evaluating-efficacy-safety-and-tolerability-of-obicetrapib-in-patients-with-heterozygous-familial.html

News Any study drug related treatment emergent adverse events occurred in 6.8% patients in the placebo arm versus 4.3% patients in obicetrapib arm ...