Hutchinson

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease CKD and high blood pressure hypertension. This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are studying adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.

Researchers are evaluating the efficacy and safety of tozorakimab, a drug administered under the skin, in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb study is designed as a double-blind, placebo-controlled trial to find the right dose range of tozorakimab for this group. The study aims to better understand how tozorakimab may impact asthma control and reduce severe asthma attacks in this population. Participants will be randomly assigned to one of three groups one receiving a lower dose of tozorakimab, another receiving a higher dose or placebo, and a third group receiving placebo injections. All treatments are given by subcutaneous injection. The study will last for 26 to 52 weeks, during which the participants will be closely monitored for asthma exacerbations and lung function changes. This includes assessing how well tozorakimab is tolerated and how it affects asthma symptoms and quality of life. During the study, participants will undergo regular assessments including lung function tests, questionnaires about asthma control and quality of life, and blood tests to measure drug levels and immune response. Researchers will track the annual rate of severe asthma flare-ups as the main outcome. Safety will be monitored throughout the study period, and participants will be followed for up to one year. The study is designed to ensure participants receive careful observation and support while contributing valuable information about tozorakimabs potential use in asthma treatment.

Researchers are evaluating olpasiran, a drug given by injection, to see if it can reduce the risk of first major heart-related events like coronary heart disease death, heart attacks, or urgent coronary procedures in people with high levels of lipoproteina and risk factors for cardiovascular disease. This is a phase 3, double-blind, randomized, placebo-controlled study aiming to improve prevention strategies for cardiovascular disease. Participants will be randomly assigned to receive either subcutaneous injections of olpasiran or a placebo. The study compares these two groups over a period of up to approximately 6.2 years to assess their impact on major cardiovascular events. The treatment is given by injection under the skin, with one group receiving the active drug and the other receiving a placebo injection. During the study, participants will be monitored regularly for heart-related events including death from coronary heart disease, heart attacks, strokes, and urgent coronary procedures. Blood levels of lipoproteina and olpasiran will be measured at baseline and at week 48. The study will also track any treatment-emergent side effects and overall health outcomes over the course of up to 6.2 years, giving a comprehensive view of the drugs potential effects and safety.

Researchers are evaluating the performance of two blood-based diagnostic tests designed to help detect cancer in individuals aged 45 and older who show symptoms, signs, or findings that suggest cancer. The study aims to assess these tests in people suspected of having cancer or those recently diagnosed but not yet treated. This observational study is sponsored by Harbinger Health and focuses on cancers originating from specific sites outlined in the study protocol. Participants will provide a blood sample of up to 40 mL collected in special tubes for analysis by the investigational diagnostic tests. Those with suspected cancer will undergo a standard diagnostic work-up to confirm if cancer is present, while those already diagnosed must be treatment-nave. The results of the diagnostic tests will not be shared with patients or doctors and will not influence clinical decisions. All testing and analyses are conducted in a blinded manner. During the study, participants will complete a blood draw and follow the usual diagnostic procedures as needed. Researchers will track clinical outcomes, diagnostic test performance, and cancer incidence over 18 months. The main measure is how well the two diagnostic tests identify cancer among participants showing relevant symptoms or signs. Safety and adherence will be monitored, but the study does not involve treatment. Total participation duration may vary depending on diagnostic and follow-up processes.

Researchers are evaluating the performance of the Shield blood test for colorectal cancer CRC screening in individuals aged 45 to 81 who are at average risk for CRC. The study focuses on the second round of testing and compares the Shield test results to colonoscopy findings. This observational study aims to gather real-world evidence on how well the Shield test detects CRC in this population, addressing the importance of early detection to reduce CRC incidence and mortality. Participants will undergo the Shield blood test at the second testing interval, which occurs between 33 and 42 months after enrollment. The study involves adults who are considered average risk for CRC, meaning they lack symptoms or increased risk factors such as a personal or family history of CRC or related conditions. The Shield test is the primary diagnostic tool being assessed, and colonoscopy is used as the reference method to evaluate its performance. During the study, participants will follow standard care procedures and comply with study assessments. Researchers will measure how well the Shield test performs at detecting CRC at the second testing interval. The study includes monitoring participants over time with standard clinical assessments and the collection of data related to CRC screening outcomes. Participation involves scheduled testing and evaluations, with safety and adherence tracked throughout the study period, which extends until December 2030.

Researchers are evaluating the effect of abelacimab compared to a placebo on reducing the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients, including those who may have increased bleeding risks and cannot or choose not to take standard blood thinners. Participants will be randomly assigned to receive either abelacimab 150 mg or a matching placebo through a monthly subcutaneous injection. The study is designed as a double-blind, placebo-controlled trial to monitor the safety and efficacy of abelacimab over a period of up to 30 months. During the study, participants will be closely monitored for the time to first occurrence of ischemic stroke, systemic embolism, and bleeding events classified by the Bleeding Academic Research Consortium. Researchers will also track cardiovascular and all-cause mortality, as well as other cardiovascular events. Participants will undergo regular assessments, including electrocardiograms and clinical evaluations, throughout the trial to ensure safety and collect data on treatment effects.

Researchers are evaluating whether the drug zilebesiran can reduce major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, and heart failure episodes in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to gather sufficient clinical outcome events to determine the drugs impact compared to placebo. Participants will receive either 300 mg of zilebesiran or a placebo through subcutaneous injection every six months, in addition to their usual antihypertensive medications that include at least two standard drugs, one being a diuretic. The study treatments are given as add-on therapy alongside the participants existing blood pressure management. The study will continue until enough cardiovascular events have occurred to assess the primary outcome. During the study, participants will be monitored for up to approximately five years. Researchers will track the time to the first occurrence of a combined endpoint including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events requiring hospitalization or urgent visits. Blood pressure changes will also be measured at six months. Safety and efficacy will be closely followed through regular visits and assessments. The long follow-up period allows for thorough evaluation of cardiovascular outcomes and treatment effects.