Nexlizet

Diet, Heart Disease, Hypercholesterolemia + 3 more
Treatment
6 FDA approvals
20 Active Studies for Nexlizet

What is Nexlizet

Bempedoic acidThe Generic name of this drug
Treatment SummaryEzetimibe 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,
Nexletolis 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 PatientsEzetimibe 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 bodyEzetimibe 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 RiskThe 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
12 Actively Recruiting
Phase 3, Not Applicable, Phase 2, Phase 4
Hypercholesterolemia
4 Actively Recruiting
Phase 1, Phase 3
Diet
5 Actively Recruiting
Not Applicable, Phase 1
Heart Disease
37 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?

2Patient 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 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.
Image of UConn Health in Farmington, United States.

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.
Waitlist Available
Has No Placebo
UConn Health (+2 Sites)Linda S Pescatello, PhD
Have you considered Nexlizet clinical trials? We made a collection of clinical trials featuring Nexlizet, we think they might fit your search criteria.Go to Trials
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 CenterDavid Kallend, MB BSLIB 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 ParnassusGregory 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
Have you considered Nexlizet clinical trials? We made a collection of clinical trials featuring Nexlizet, we think they might fit your search criteria.Go to Trials
Image of Research Site in Chula Vista, United States.

AZD0780 for Hypercholesterolemia

18+
All Sexes
Chula Vista, CA
This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
Phase 3
Recruiting
Research Site (+28 Sites)AstraZeneca
Image of University of Alabama at Birmingham in Birmingham, United States.

Genetic Information for High Blood Pressure

18 - 55
All Sexes
Birmingham, AL
In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.
Recruiting
Has No Placebo
University of Alabama at BirminghamPankaj Arora, MD, FAHA
Image of Abcentra Investigational Site in Los Angeles, United States.

Orticumab for Heart Attack

18+
All Sexes
Los Angeles, CA
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is: Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA Researchers will compare the effects with placebo group after 6 months of treatment Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies
Phase 2
Recruiting
Abcentra Investigational Site (+6 Sites)Abcentra
Have you considered Nexlizet clinical trials? We made a collection of clinical trials featuring Nexlizet, we think they might fit your search criteria.Go to Trials
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security