Sun City West

Researchers are investigating the effects of obicetrapib 10 mg, both combined with ezetimibe 10 mg as a fixed-dose combination and as monotherapy, in people with metabolic syndrome and/or Type 2 Diabetes Mellitus who are already receiving standard lipid-lowering therapy. This Phase 3, placebo-controlled, double-blind, randomized study aims to evaluate how well these treatments lower LDL cholesterol and assess their safety and tolerability. Participants will be assigned to one of three groups: obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination, obicetrapib 10 mg alone, or placebo, all added to their existing guideline-recommended lipid-lowering therapy. The treatments are taken daily, and the study measures the percent change in LDL cholesterol from the start to Day 84. During the study, participants will undergo regular monitoring including lipid measurements and safety assessments. Researchers will carefully track changes in LDL cholesterol and other health markers over the 84-day treatment period. The study focuses on how these treatments perform in real-world patients with metabolic syndrome or Type 2 Diabetes while continuing standard care.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effects of KAI-9531, given by weekly subcutaneous injection, compared to a placebo in adults living with obesity who do not have diabetes. This Phase 2b study aims to determine how KAI-9531 impacts body weight over time, specifically measuring the percent change from baseline to week 48. Participants will receive either KAI-9531 or a placebo via subcutaneous injection once a week during the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatment and placebo groups. The main treatment period lasts 48 weeks. During the study, participants will have their body weight measured at baseline and at week 48 to assess changes. Researchers will monitor safety and efficacy throughout the treatment period. The total participation time includes the treatment period and any necessary follow-up visits to track outcomes and ensure participant well-being.

Researchers are investigating the effects of pelacarsen (TQJ230) compared to a placebo in adults with atherosclerotic cardiovascular disease (ASCVD) who have high levels of lipoprotein(a) (Lp(a)) and are also receiving inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C). The study is designed as a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial with a parallel group structure, followed by an open-label treatment period. The aim is to assess the efficacy, safety, and tolerability of pelacarsen in this population. Participants will receive pelacarsen or placebo as a solution for subcutaneous injection using prefilled syringes. All participants will be given background treatment with inclisiran, starting with two loading doses spaced three months apart during the run-in period. Afterward, inclisiran will be administered every six months at Month 5 and Month 11. Following the double-blind phase, an open-label treatment period will continue, allowing further evaluation of the treatments. Throughout the study, participants will undergo assessments including measurement of lipoprotein(a) levels, with the primary outcome focusing on change in log-transformed Lp(a) concentration from baseline to six months. Laboratory tests will monitor LDL-C and other relevant markers. Safety and tolerability will be tracked continually, and standard care for cardiovascular risk factors such as hypertension and diabetes will be maintained. The study includes adults aged 18 to 80 years with established ASCVD and elevated lipid levels, ensuring ongoing monitoring and evaluation of treatment effects.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.