Hutchinson

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating ways to improve advance care planning (ACP) among underserved communities, who often receive lower quality end-of-life care and unwanted, costly treatments. This study compares two conversation-based tools designed to encourage discussions about end-of-life wishes and motivate ACP behaviors. The goal is to increase high-quality end-of-life care, reduce health disparities, and lessen unnecessary suffering for patients and families. The study is a cluster randomized controlled trial involving 75 underserved communities across the US. It compares a serious conversation game called Hello, the widely used Conversation Project (CP) Starter Kit, and usual care where only an advance directive is distributed. The Hello game has 32 questions prompting sharing of values and beliefs about end-of-life issues, while the CP Starter Kit is a workbook with prompts and resources to facilitate conversations. The third group receives a general conversation game called Table Topics. Participants include adults from underserved populations who have not completed an advance directive in the past 5 years. Researchers will assess completion of a visually verified advance directive six months after the intervention. Other ACP behaviors will also be measured. The study involves community events, follow-up, and data collection to understand which tools best engage underserved groups in ACP and improve end-of-life care outcomes.

Researchers are evaluating the performance of two new blood-based tests designed to help detect cancer in adults aged 45 and older who show symptoms or signs that suggest cancer might be present. These tests focus on multiple cancers, including those in the gastrointestinal system, to improve early diagnosis and guide further medical evaluation. Participants will have up to 40 mL of blood collected for analysis with the investigational diagnostic tests. For those suspected of having cancer, standard diagnostic procedures will be followed to confirm the diagnosis, while participants already diagnosed with cancer must not have started treatment prior to enrollment. The results of the investigational tests will be kept confidential and will not influence clinical care decisions, ensuring unbiased evaluation. During the 18 months following enrollment, researchers will assess the accuracy and performance of these diagnostic tests by comparing their results with clinical diagnoses confirmed through standard care. Participants may undergo routine clinical evaluations, imaging, and pathology reviews as part of their care. The study team will monitor outcomes and maintain blinding to test results to ensure objective assessment throughout the study period.

Researchers are evaluating the Shield blood test as a screening tool for colorectal cancer (CRC) in people aged 45 to 81 who are at average risk for CRC. This study aims to assess how well the Shield test performs during a second round of testing, using colonoscopy as the standard comparison. Colorectal cancer is a common and serious disease, especially in older adults, and early detection through screening can reduce mortality by catching cancer at earlier, more treatable stages. Participants will undergo the Shield blood test as part of their standard care. The study focuses on average-risk individuals who do not have symptoms or high-risk factors for CRC. The performance of the Shield test will be monitored over a period of 33 to 42 months after enrollment to evaluate its effectiveness compared to colonoscopy results. During the study, participants will follow study procedures and standard care assessments. Researchers will measure the performance of the Shield test in detecting colorectal cancer and its precursors during the second testing interval. This includes ongoing monitoring and data collection to understand the test's accuracy and reliability in a real-world setting, with a total follow-up period extending beyond two and a half years.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

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.