This trial is evaluating whether lerodalcibep will improve 1 primary outcome and 2 secondary outcomes in patients with Hypercholesterolemia. Measurement will happen over the course of 12 weeks.
This trial requires 220 total participants across 3 different treatment groups
This trial involves 3 different treatments. Lerodalcibep is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
Hypercholesterolemia is a major cardiovascular risk factor. It is highly prevalent in developed nations and is strongly associated with atherosclerosis and coronary heart disease. Statin therapy is the preferred drug for achieving cholesterol goals. Statins reduce cardiovascular events and mortality in men but may be associated with an adverse effect of increasing cancer risk, particularly in women (postmenopausal) who frequently utilize them for high cholesterol management. A possible causal relationship has also been reported between high cholesterol levels and ovarian cancer. The link between statin use and breast cancer risk in a meta-analysis of the randomized controlled trials is still unclear.
About 47 million people are diagnosed with hypercholesterolemia in the United States. Hypercholesterolemia is a leading cause of death in the United States. This article reports on key recent findings.
Treatment of severe hypercholesterolemia is largely dictated by the magnitude of elevated LDL-C levels and the rate at which LDL-C levels decrease in response to a lipid-lowering regimen. In the pre-statin era, LDL-C was typically treated by reducing total and LDL-C levels with statins, while higher LDL-C levels were treated with dietary modifications. In recent years, statin therapy has typically replaced dietary interventions or lifestyle changes in the treatment of hypercholesterolemia. Newer lipid-lowering agents may provide similar clinical gains at lower lipid concentrations when compared to statins alone.
Variations in lifestyle and diet are the major factors in the development of hypercholesterolemia because they are related to the enzyme levels involved in cholesterol biosynthesis, metabolism and excretion.
Hypercholesterolemia is a risk factor for cardiovascular disease (CVD). As a consequence, screening for and treatment of hypercholesterolemia might have preventive advantages. In a recent study, findings support current recommendations to take a careful personal medical history of symptoms, as well as to perform a complete cardiovascular risk factor prevention.
The early signs of hypercholesterolemia include unexplained excessive weight loss. Early signs of hyperhomocapnogeism are abdominal pain, excessive gas filled in the abdomen, abdominal swelling and loss of appetite. People should be checked for early signs of hypercholesterolemia during the early years of life.
The most commonly reported side effects were headache, nausea and diarrhoea, but they were generally mild and only temporary. In summary, the data suggest that lerodalcibep can be safely administered at its therapeutic dose.
Lerodalcibep is an oral steroidal medication aimed to treat hypercholesterolemia which enhances lipid-lowering and anti-inflammatory effects in patients with severe hyperlipidemia, mainly in hypercholesterolemic patients with autoimmune dyslipidemia. This drug is administrated once a day for 8 weeks. The therapeutic efficacy of lerodalcibep seems to be greater than lovastatin.
Hypercholesterolemia can be an urgent problem for patients in their 30s and 40s, especially for those who do not have family members with premature coronary artery disease. The number of patients with hypercholesterolemia has been increasing in recent decades, possibly because of the growing obese population. In the first six months after diagnosis of hypercholesterolemia, 40% of patients with hypercholesterolemia die. This percentage is higher for patients with severe hypercholesterolemia. Early detection and risk factor correction can prevent the progression of coronary artery disease and decrease atherosclerotic complications.
This paper is a summary of the current literature on hypercholesterolemia, with emphasis on the most recent research. The emphasis is on lipid profiles as well as treatment modalities and lipid profiles will be discussed.
Recent findings do not demonstrate an increase in LDL-C levels in FH families, when compared to healthy control and FH families and with controls; therefore, there is no support for the hypothesis that a non-familial clustering of these conditions exists in that population.
Lerodalcibep is a non-steroidal anti-inflammatory drug currently in use in clinical trials as a therapeutic option for the treatment of osteoarthritis of the knee with proven efficacy and safety demonstrated in Phase III trial. The Phase II Study confirmed the effect observed in Phase III Clinical study showing a consistent improvement in both clinical scores and function of osteo(arthritis) of the knee.