Nexlizet

Diet, Heart Disease, Hypercholesterolemia + 3 more

Treatment

6 FDA approvals

20 Active Studies for Nexlizet

What is Nexlizet

Bempedoic acid

The Generic name of this drug

Treatment Summary

Ezetimibe is an oral medication used to lower cholesterol levels. It works by blocking the absorption of cholesterol and plant-based fats in the intestines. Ezetimibe is usually taken in combination with a healthy diet and is effective for treating primary hyperlipidemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. Unlike other cholesterol-lowering medications, ezetimibe does not interfere with the absorption of fat-soluble vitamins or other nutrients. It works by blocking a protein called Niemann-Pick C1-Like 1,

Nexletol

is the brand name

image of different drug pills on a surface

Nexlizet Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Nexletol

Bempedoic acid

2020

2

Approved as Treatment by the FDA

Bempedoic acid, commonly known as Nexletol, is approved by the FDA for 6 uses such as Heterozygous Familial Hypercholesterolemia (HeFH) and Hyperlipidemias .

Heterozygous Familial Hypercholesterolemia (HeFH)

Hyperlipidemias

Atherosclerotic Cardiovascular Diseases

Therapeutic procedure

Hypercholesterolemia

Diet

Effectiveness

How Nexlizet Affects Patients

Ezetimibe is a drug used to treat high levels of cholesterol, including total cholesterol, LDL cholesterol, Apo B, non-HDL cholesterol and triglycerides. It also increases HDL cholesterol. When taken with either a statin or fenofibrate, the effects of ezetimibe are more pronounced. In clinical trials, it was found to reduce LDL levels by 15-20% and increase HDL-C by 2.5-5%. Those with moderate to severe liver problems should not take ezetimibe. Additionally, there may be an increased risk of muscle-related side effects such as my

How Nexlizet works in the body

Ezetimibe helps lower blood cholesterol levels by blocking the absorption of cholesterol and phytosterol in the intestines. It works by targeting the protein Niemann-Pick C1-Like 1 (NPC1L1), which is responsible for transporting cholesterol into cells. Ezetimibe prevents the NPC1L1 protein from binding to cholesterol and other sterols, which stops them from being absorbed into the cells. It also disrupts other proteins involved in regulating cholesterol uptake, preventing them from absorbing the cholesterol. As a result, the cholesterol is not collected in the cells and is instead removed from the body through the bloodstream

When to interrupt dosage

The measure of Nexlizet is determined by the diagnosed condition, including Diet, Homozygous Familial Hypercholesterolemia and Hyperlipidemia. The degree of dosage can be found in the table underneath, contingent upon the method of administration (e.g. Oral or Tablet).

Condition

Dosage

Administration

Hyperlipidemias

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Heart Disease

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Diet

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Hypercholesterolemia

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Atherosclerotic Cardiovascular Diseases

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Therapeutic procedure

, 180.0 mg

Tablet, film coated - Oral, , Oral, Tablet, film coated

Warnings

Nexlizet has three contraindications. It should not be administered when having any of the conditions given in the following table.

There are 20 known major drug interactions with Nexlizet.

Common Nexlizet Drug Interactions

Drug Name

Risk Level

Description

Revefenacin

Major

Bempedoic acid may decrease the excretion rate of Revefenacin which could result in a higher serum level.

Ambrisentan

Minor

The excretion of Ambrisentan can be decreased when combined with Bempedoic acid.

Asunaprevir

Minor

The excretion of Asunaprevir can be decreased when combined with Bempedoic acid.

Atorvastatin

Minor

The excretion of Atorvastatin can be decreased when combined with Bempedoic acid.

Atrasentan

Minor

The excretion of Atrasentan can be decreased when combined with Bempedoic acid.

Nexlizet Toxicity & Overdose Risk

The lowest toxic dose of sitosterolemia in rats has been found to be greater than 2000mg/kg. The same is true for mice with a LD50 value of >5000mg/kg, and dogs with a LD50 value of >3000mg/kg. One instance of an overdose occurred in a clinical study in a female patient, but no adverse effects were reported. If an overdose occurs, symptomatic treatments should be administered.

image of a doctor in a lab doing drug, clinical research

Nexlizet Novel Uses: Which Conditions Have a Clinical Trial Featuring Nexlizet?

At present, 8 active trials are evaluating the potential of Nexlizet in relieving sitosterols, Diet and Lipid-related issues.

Condition

Clinical Trials

Trial Phases

Hyperlipidemias

0 Actively Recruiting

Atherosclerotic Cardiovascular Diseases

13 Actively Recruiting

Phase 3, Not Applicable, Phase 2, Phase 4, Phase 1

Hypercholesterolemia

4 Actively Recruiting

Phase 1, Phase 3

Diet

4 Actively Recruiting

Not Applicable, Phase 1

Heart Disease

41 Actively Recruiting

Not Applicable, Phase 3, Phase 2, Phase 1, Phase 4, Early Phase 1

Therapeutic procedure

0 Actively Recruiting

Nexlizet Reviews: What are patients saying about Nexlizet?

2

Patient Review

7/28/2021

Nexlizet for Heterozygous Inherited High Blood Cholesterol

I tried the 180 Mg/10 dosage in an effort to lower my high cholesterol. Unfortunately, I had to discontinue after 5 weeks due to severe side effects including leg, back and stomach cramps and spasms, as well as a rash and hives on my left side. This product includes a small amount of Zetia which I am allergic to.

Patient Q&A Section about nexlizet

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the drug Nexlizet used for?

"Bempedoic acid and ezetimibe are used together with a proper diet and other medications to help lower LDL cholesterol. Bempedoic acid reduces the amount of cholesterol made by the liver. Ezetimibe reduces the amount of cholesterol your body absorbs from your diet."

Answered by AI

What are the side effects of Nexlizet?

"If you experience swelling of your eyelids, lips, hands, or feet, this may be a symptom of an allergic reaction to Nexlizet. If you also experience swelling of your tongue, mouth, or throat, which makes it difficult to breathe, you should call your doctor immediately."

Answered by AI

What time of day is best to take Nexlizet?

"What is the best time of day to take Nexlizet? You can take it at any time, with or without food, but try to take it at the same time each day. If you're taking medication that binds to bile acids like colesevelam or cholestyramine, make sure to take Nexlizet at least 2 hours before or 4 hours after taking those medications."

Answered by AI

Is Nexlizet a statin drug?

"The Food and Drug Administration approved Nexlizet in 2020 to help reduce LDL cholesterol in adults. Nexlizet became the first combination drug approved for this use that doesn't contain a statin."

Answered by AI

Clinical Trials for Nexlizet

Image of Nationwide Children's Hospital in Columbus, United States.

Nutrition and Lifestyle Interventions for Heart Disease

Any Age
All Sexes
Columbus, OH

The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are: * Do the new tools (PRO-CVH and Triple-C) help families improve their heart health? * Which combination of tools and supports works best for families with limited access to healthy food? * Is this type of program easy to carry out and acceptable to families and healthcare teams? Families in the study will include one parent with a BMI greater than 30 who has Medicaid insurance and their child aged 6 to 11 years. Depending on which group they are assigned to, families may: * Receive food and nutrition education via handouts and/or online curriculum * Have access to an online health assessment tool than can help you understand your/your child's risk factors for heart disease * Work with a personalized health coach who can help you set goals for healthier living online/virtually. * Receive medically tailored groceries and cooking classes. Researchers will follow participants for several months to see how their heart health changes and which parts of the program work best together. The information from this study will help design a larger clinical trial to test a practical, cost-effective program that can help families build healthier habits and reduce their risk of heart disease.

Waitlist Available
Has No Placebo

Nationwide Children's Hospital

Image of Mumford Professional Centre in Halifax, Canada.

Remote Monitoring for Cardiovascular Disease

18+
All Sexes
Halifax, Canada

The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program. The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program. The primary objectives of this study are to: 1. Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not. 2. Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by: 1. Tracking patient enrollment, attendance in virtual education sessions, and program completion rates, 2. Evaluating change in patient bloodwork outcomes, 3. Measuring change is physical ability, 4. Analyzing changes in eating behaviours, and 5. Examining quality of life using validated tools. 3. Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by: 1. Assessing device adherence 2. Reviewing patient feedback survey, and 3. Determining if clinician team were able to access and interpret data collected throughout the program The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program. This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.

Waitlist Available
Has No Placebo

Mumford Professional Centre

Nicholas B Giacomantonio, Medical Doctor

Corsano Health B.V.

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Image of U Health in Miami, United States.

Cuffless PPG Monitor for High Blood Pressure

18+
All Sexes
Miami, FL

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Waitlist Available
Has No Placebo

U Health (+1 Sites)

Ziad Zoghby, M.D., M.B.A.

Biobeat Technologies Ltd.

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Digital Exercise Prescription Tool for Cardiovascular Disease

18 - 64
All Sexes
Farmington, CT

The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.

Recruiting
Has No Placebo

UConn Health (+2 Sites)

Linda S Pescatello, PhD

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Image of Metabolic & Atherosclerosis Research Center in Cincinnati, United States.

Lerodalcibep for High Cholesterol

6 - 17
All Sexes
Cincinnati, OH

The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP) compared to placebo (dummy), in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins. The main question\[s\] it aims to answer are: How effective is Lerochol in reducing LDL cholesterol? How well is it tolerated and are there any safety concerns? Researchers will compare Lerochol to placebo (inert or dummy injection solution). Participants will visit the clinic every month for months and be asked to fast overnight, but allowed to drink water, before clinic visits. Undergo physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.

Phase 3
Waitlist Available

Metabolic & Atherosclerosis Research Center

David Kallend, MB BS

LIB Therapeutics LLC

Image of UCSF Medical Center at Parnassus in San Francisco, United States.

Whole Milk vs Skim Milk for Insulin Resistance

18+
All Sexes
San Francisco, CA

Atherosclerotic cardiovascular disease remains the leading cause of death for adults in the United States. The cardiovascular impact of milk consumption remains a matter of long-standing scientific debate. Current guidelines for Americans recommend three daily servings of fat-free or low-fat (1%) dairy over full-fat options due to concerns that saturated fat may increase cardiovascular risk. Yet, the literature does not consistently support non-fat dairy as superior to high-fat dairy for reducing cardiometabolic risk. Identifying the comparative health benefits of non-fat versus high-fat dairy milk would be immediately applicable to patients who seek cardiovascular care. In this randomized, case-crossover trial, the investigators seek to efficiently assess the association between high-fat versus non-fat dairy milk consumption and insulin resistance. Utilizing the Eureka Platform, participants will be randomized to limit their liquid milk consumption to whole milk followed by skim milk (or vice versa), measuring the effect of milk fat content on glycemic index and lipid profile.

Recruiting
Has No Placebo

UCSF Medical Center at Parnassus

Gregory M Marcus, MD, MAS

Image of North Florida/South Georgia Veterans Health System, Gainesville, FL in Gainesville, United States.

Referral Program for Cardiac Rehabilitation

18+
All Sexes
Gainesville, FL

This study will test whether the Veterans Cardiac Rehabilitation Referral Program (VCR2P) improves cardiac rehabilitation participation by studying 816 Veterans across three VA medical centers in Nashville, Dallas, and Gainesville over 12 months. The trial compares referral rates from the 6 months before implementing the program to 6 months after, using a "before and after" design since randomization would be impractical. The study will measure whether the program increases the proportion of eligible Veterans who receive cardiac rehabilitation referrals and whether more Veterans actually attend rehabilitation sessions. Additionally, focus groups with physicians, nurses, and Veterans will identify what helps or hinders the program's success, providing essential insights for expanding this intervention to other VA facilities nationwide if it proves effective.

Waitlist Available
Has No Placebo

North Florida/South Georgia Veterans Health System, Gainesville, FL (+2 Sites)

Justin M Bachmann, MD MPH

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