Riverhead

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

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 effectiveness of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 2 trial focuses on patients with PD-L1 tumor proportion score (TPS) of 1% or higher, but less than 50%, who have not received prior systemic therapy for advanced disease. The study aims to assess how well this combination works as a first treatment option for this patient group. Participants receive adagrasib as oral tablets twice daily at a dose of 400 mg. Pembrolizumab and chemotherapy drugs (pemetrexed and either cisplatin or carboplatin) are given by intravenous infusion once every three weeks. The study includes several groups based on prior treatments and PD-L1 levels, with some participants having previously completed induction chemotherapy. Treatments are administered according to these schedules and patient eligibility. During the study, researchers monitor participants for tumor response and progression-free survival over 30 months. They use standard criteria to measure tumor size changes and disease progression. Assessments include clinical evaluations and imaging to track response to treatment. Safety and tolerability are also monitored throughout the study period to understand the effects of the combination therapy on patients.

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 use of CardioMems and BaroStim devices to manage patients with Heart Failure classified as NYHA Class III and reduced ejection fraction. This longitudinal, single-arm study aims to use pulmonary artery diastolic pressure measurements from CardioMems to assess the effects of BaroStim therapy. The study focuses on improving several health markers including walking ability, blood pressure, heart function, and heart failure classification over time. Participants first receive a CardioMems device and undergo three months of medication management and optimization. After this period, the BaroStim device is implanted. The BaroStim device includes a carotid sinus lead and an implantable pulse generator. Following insertion, patients have in-office visits to adjust the BaroStim device while monitoring pulmonary artery diastolic pressure, aiming for a pressure of 18-20 mm Hg or less. Patients will be followed for one year after BaroStim insertion. During the study, participants will have regular assessments including pulmonary artery diastolic pressure during procedures, six-minute walk tests, blood pressure monitoring, heart failure classification, NT-pro BNP levels, left ventricular ejection fraction, and medication usage. These will be measured up to one year post-BaroStim insertion to evaluate clinical improvements. Safety and adherence are monitored throughout the study period to ensure proper management and follow-up.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved treatment alternatives. This Phase 3, multicenter, randomized, open-label study compares the Bria-IMT regimen combined with the checkpoint inhibitor Retifanlimab against treatment chosen by patients or physicians. The study also aims to assess the activity of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. Participants are initially randomized equally into three groups: Bria-IMT plus Retifanlimab, treatment of physician's choice (TPC), and Bria-IMT alone. After enrollment of 150 patients, the monotherapy group is discontinued, allowing crossover to combination therapy if needed, with subsequent randomization continuing between combination therapy and TPC. Treatment cycles for Bria-IMT with or without Retifanlimab occur every three weeks, including cyclophosphamide given 2-3 days before SV-BR-1-GM inoculations, SV-BR-1-GM administered intradermally, interferon injections at inoculation sites, and Retifanlimab infusions timed consistently each cycle. TPC is given according to standard care at each site using approved drugs including chemotherapy and targeted agents. Participants undergo imaging assessments every six weeks twice, then every eight weeks during treatment if disease is stable and no major safety issues arise. Safety and overall survival will be monitored up to 60 months. Eligibility requires confirmation of advanced breast cancer with prior therapies failed, and participants must have an ECOG performance status of 0 to 2 with expected survival of at least four months. The study includes comprehensive assessments, treatment monitoring, and long-term follow-up to evaluate outcomes and safety.

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.