What side effects are associated with this type of intervention?

Common treatments for high cholesterol include statins, ezetimibe, PCSK9 inhibitors, and CETP inhibitors like Obicetrapib. Statins can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Ezetimibe is generally well-tolerated but can cause gastrointestinal issues and muscle pain. PCSK9 inhibitors, such as alirocumab and evolocumab, may cause injection site reactions, hypersensitivity, and, rarely, neurocognitive symptoms. CETP inhibitors, while still under study, have shown potential side effects including increased blood pressure and liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of high cholesterol, including statins (e.g., atorvastatin, rosuvastatin), ezetimibe, and PCSK9 inhibitors (e.g., alirocumab, evolocumab). Statins are typically the first line of treatment due to their efficacy in lowering LDL-C and reducing cardiovascular events. Ezetimibe is often added if statins alone are insufficient. PCSK9 inhibitors are used for patients who do not achieve their LDL-C goals with statins and ezetimibe. While CETP inhibitors like Obicetrapib are being studied, they are not yet approved by the FDA. These drugs aim to lower cholesterol by inhibiting the cholesteryl ester transfer protein, which plays a role in lipid metabolism.

What other types of research exist?

Promising novel alternatives to Obicetrapib for high cholesterol patients in 2024 include PCSK9 inhibitors (e.g., evolocumab, alirocumab), bempedoic acid, and inclisiran. These therapies have demonstrated significant efficacy in lowering LDL cholesterol levels and are supported by recent clinical trials.

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Obicetrapib for High Cholesterol (BROADWAY 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

Are on maximally tolerated lipid-modifying therapy including statins, ezetimibe, bempedoic acid, or PCSK-9 targeted therapy

Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows: A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening Atorvastatin 40 and 80 mg; and Rosuvastatin 20 and 40 mg; Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening

Must not have

Active liver disease

Uncontrolled severe hypertension with specified blood pressure ranges

Timeline

Screening 3 weeks

Treatment Varies

Follow Up percent change from baseline to day 84, day 180, and day 365 in tg

Awards & highlights

Pivotal Trial

Summary

This trial is testing obicetrapib, a medication that helps lower bad cholesterol levels. It targets people with high cholesterol that isn't fully managed by their current treatments and diet. The medication works by reducing the amount of bad cholesterol in the blood, which can help prevent heart disease.

Who is the study for?

This trial is for adults with high cholesterol or heart disease who are already on the highest dose of cholesterol-lowering meds they can handle. They should have a specific genetic condition (HeFH) or a history of cardiovascular disease, and their kidneys must work well. Pregnant or breastfeeding women, or those planning to become pregnant during the study, cannot participate.

What is being tested?

The trial is testing Obicetrapib's effectiveness when added to existing treatments for lowering cholesterol compared to a placebo. It's in phase 3, meaning it's closer to potentially being approved if results are positive. Participants won't know whether they're getting the real drug or a dummy pill.

What are the potential side effects?

While not specified here, common side effects from drugs like Obicetrapib may include digestive issues, muscle pain or weakness, liver problems which might show up as fatigue or yellowing skin/eyes, and increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking the highest dose of cholesterol medication that I can tolerate.

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I've been on the highest dose of cholesterol medication I can handle for at least 8 weeks.

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I have a genetic condition that causes high cholesterol or a history of heart disease.

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My LDL cholesterol levels fall within the required range.

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I am currently taking Atorvastatin or Rosuvastatin at the specified doses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing liver condition.

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My blood pressure is very high and not under control.

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My heart's pumping ability is severely reduced.

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I have been diagnosed with homozygous familial hypercholesterolemia.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ percent change from baseline to day 84, day 180, and day 365 in tc

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~percent change from baseline to day 84, day 180, and day 365 in tc

This trial's timeline: 3 weeks for screening, Varies for treatment, and percent change from baseline to day 84, day 180, and day 365 in tc for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Apolipoprotein A1 (ApoA1)

HDL-C

LDL-C

+5 more

Other study objectives

Cardiovascular hospitalizations

Major adverse cardiac event (MACE)

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT04753606

Inflammation

Temporomandibular joint syndrome

Tendonitis

Arthralgia

Lumbar spinal stenosis

Somnolence

Arthropod sting

Glaucoma

Renal impairment

Headache

Cardiomegaly

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Obicetrapib 10 mg

Obicetrapib 5 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: obicetrapib 10mgExperimental Treatment1 Intervention

one 10mg obicetrapib 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

2024

Completed Phase 3

~3370

0 / 10Eligibility criteria met

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 high cholesterol include statins, ezetimibe, PCSK9 inhibitors, and CETP inhibitors. Statins work by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis, thereby lowering LDL-C levels. Ezetimibe reduces cholesterol absorption in the intestines. PCSK9 inhibitors increase the number of LDL receptors on liver cells, enhancing the clearance of LDL-C from the bloodstream. CETP inhibitors, such as Obicetrapib, raise HDL-C levels and lower LDL-C levels by inhibiting the protein that transfers cholesteryl esters from HDL to LDL particles. These mechanisms are crucial for high cholesterol patients as they help reduce the risk of cardiovascular events by effectively managing and lowering harmful cholesterol levels.

New Approaches in Detection and Treatment of Familial Hypercholesterolemia.Cholesteryl ester transfer protein (CETP) deficiency and CETP inhibitors.