Izumisano

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.

This research aims to evaluate the safety and effectiveness of a medicine called ibuzatrelvir, alone and combined with remdesivir, compared to remdesivir alone in adults who have symptomatic COVID-19 and are severely immunocompromised. Immunocompromised patients often have difficulty fighting infections and may face persistent or severe COVID-19 illness. The study is a Phase 3, randomized, double-blind trial involving adult participants who are either non-hospitalized or hospitalized for observation but do not need supplemental oxygen for COVID-19. Participants will be randomly assigned to one of three groups: one receiving remdesivir alone, one receiving ibuzatrelvir alone, and one receiving both ibuzatrelvir and remdesivir. Ibuzatrelvir is taken orally twice daily, while remdesivir is given by daily intravenous infusion. Placebo tablets and injections will be used to keep the treatment groups visually similar. The study compares how participants respond to ibuzatrelvir with or without remdesivir versus remdesivir alone. Participants will attend around 10 study visits over 24 weeks, which include clinic visits, blood tests, and nasal swabs collected both in the clinic and by participants at home. They will also complete questionnaires. Researchers will measure the proportion of patients who meet the primary outcome after 38 days and monitor safety throughout the study.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

This research aims to observe the safety and effectiveness of dabrafenib and trametinib in patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer. It is a prospective, multicenter, single-arm, non-interventional observational study conducted through a central registration system using electronic data capture. The study includes both adult and pediatric patients, with long-term monitoring planned to collect comprehensive safety data. Patients already prescribed Tafinlar/Mekinist (dabrafenib and trametinib) before joining the study will be enrolled without treatment allocation or changes. The study targets 65 adult patients for effectiveness analysis and approximately 20 pediatric patients. Pediatric patients will be observed for up to 8 years after starting treatment to gather long-term information, while adult patients will be followed for one year post-treatment initiation. During participation, patient safety and treatment response will be monitored through reports of adverse events and overall response rates. Pediatric patients will have ongoing safety assessments related to skeletal and sexual development over the 8-year period. Adults will have their treatment response evaluated over one year. Data collection includes long-term follow-up regardless of treatment discontinuation, aiming to provide comprehensive post-marketing surveillance information on these medications.

This research investigates the safety of tisagenlecleucel (CTL019) that does not meet the usual commercial release standards, focusing on patients treated within the approved label by the Japan Health Authority. The study includes pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (pALL) and adults with relapsed or refractory large B-cell lymphoma (LBCL) and related types for Part 1. Part 2 includes patients with relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphomas. The study is a Phase IIIb, open-label, multicenter trial assessing both safety and key efficacy for Part 1, with safety the main focus in Part 2. Participants receive a single intravenous infusion of CTL019, which consists of CAR-positive viable T cells. Part 1 participants are followed for 3 months after infusion, while Part 2 participants are followed for 1 day. Patients are included if their tisagenlecleucel batch does not meet commercial release standards but is individually approved by Novartis teams for safety. The study excludes those with certain infections, CNS lymphoma, hypersensitivity, or uncontrolled infections in Part 1, while Part 2 follows the product’s approved guidelines. During the study, participants undergo safety monitoring to record adverse events from screening through follow-up periods (3 months for Part 1 and 1 day for Part 2). Investigators carefully assess each patient's response and safety outcomes related to the tisagenlecleucel treatment. Informed consent is required before participation, and patients are observed for any side effects or reactions connected to the investigational infusion.