Adachi City

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

Researchers are evaluating the effectiveness and safety of a new investigational device compared to the standard autologous iliac bone graft ICBG for patients needing bone fusion through spinal fixation at two levels in the lower spine L2-S1. This study focuses on individuals with disc degeneration or spinal deformity requiring intervertebral support and spine stabilization. It is a prospective, multi-center, open-label, randomized clinical trial aiming to assess treatment outcomes in this patient group. Participants will be randomly assigned to receive either the investigational device MDT-0123, which includes a spine cage and a kit, or the standard treatment using the MDT-0123 spine cage combined with ICBG. The goal is to compare these two approaches for lumbar vertebral fusion over a treatment period. The study is conducted before the market release of the device and follows a parallel group design. During the trial, participants will undergo assessments over 12 months to measure success and safety, including changes in disc height, general health condition, disability index, and pain levels in the lower back and legs. Researchers will also track the time required for bone fusion. Participants will have regular follow-ups to monitor outcomes and safety. The total study period extends up to 12 months after the procedure, with detailed evaluations to understand the effectiveness of the treatments.

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Researchers are evaluating the long-term safety of nivolumab alone or in combination with other cancer therapies in patients with various tumor types. This Phase 2 study focuses on monitoring the effects and side effects of these treatments over an extended period to understand their safety profiles better. Participants receive one of several treatment regimens involving drugs such as nivolumab, ipilimumab, cabozantinib, trametinib, relatlimab, and others. Each treatment is given at specified doses on set days, with some regimens combining multiple drugs. The study includes patients who have previously participated in Bristol-Myers Squibb sponsored trials and may continue or restart treatment based on prior response. Throughout the study, participants undergo regular safety assessments to track adverse events, including serious, immune-mediated, and drug-related side effects. Monitoring continues from the first day of treatment up to 135 days after stopping treatment to assess the incidence of adverse events and deaths. This comprehensive safety monitoring helps researchers understand the long-term effects of these cancer therapies over several years.

Researchers are studying whether pemafibrate can help prevent worsening of intracranial arterial stenosis ICAS in adults who have symptomatic ICAS and high triglyceride levels following an ischemic stroke or transient ischemic attack TIA. This open-label, randomized, parallel-group trial compares participants receiving pemafibrate with those receiving standard care without pemafibrate to evaluate its effects on ICAS progression, triglyceride levels, vascular risk markers, vascular events, functional outcomes, and safety over 12 months. Participants will be randomly assigned to either a group receiving pemafibrate plus standard medical therapy or a group receiving standard therapy alone. Those in the pemafibrate group will take the medication for 12 months, with dose adjustments possible based on triglyceride levels and kidney function. Both groups will continue standard stroke care, including treatments for blood pressure, cholesterol, diabetes, and smoking. Brain CT angiography CTA will be performed at the start of the study and after 12 months. Additional imaging and vascular tests like brain MRIMRA, ankle brachial index, cardio ankle vascular index, and pulse wave velocity will follow the study schedule. Throughout the year-long study, participants will have blood tests and clinical assessments at baseline and during follow-up visits. Researchers will monitor vascular events, functional outcomes using scales such as the modified Rankin Scale, and adverse events. Changes in intracranial arterial stenosis on CTA are the main outcome measured at baseline and 12 months. Safety and multiple vascular and imaging markers will be evaluated at various points. Participants will be followed closely for one year to assess the effects and safety of pemafibrate in this population.