Shiwa

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

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.