Shimonoseki

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.

Researchers are evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. This phase 2 study compares different doses of CDR132L with a placebo, which is an inactive treatment. The study aims to understand the safety and effectiveness of CDR132L in reversing heart remodeling in this population. Participants will receive either CDR132L or placebo administered intravenously once every 4 weeks. The study treatment period lasts about 24 weeks, followed by additional assessments leading up to a total study duration of approximately 60 weeks. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the main phase. During the study, participants will undergo various evaluations including heart imaging via echocardiography to measure heart function and structure, laboratory tests including NT-proBNP levels, and monitoring of heart failure symptoms. The main outcome measured is the change in normalized microRNA-132-3p levels from baseline to week 24. Researchers will also monitor safety and treatment effects throughout the study, which includes regular visits and assessments over the full 60-week period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

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 effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of a study drug called JNJ-88545223 compared to a placebo in adults with active psoriatic arthritis (PsA). The goal is to see if treatment with JNJ-88545223 can reduce the signs and symptoms of PsA and improve the health of joints and skin. This is a phase 2b, randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive either JNJ-88545223 or a placebo orally. The study includes different dose levels to determine the best dose for treatment. The treatment period lasts for 16 weeks, during which the effects of the drug on PsA symptoms will be assessed. During the study, participants will be monitored to see how many achieve a 50% improvement in their symptoms according to the American College of Rheumatology criteria at week 16. Assessments may include joint evaluations, skin examinations, and laboratory tests such as C-reactive protein levels. Safety and response to treatment will be closely observed throughout the trial.

Researchers are evaluating the safety and effectiveness of a drug called GSK4532990 in adults aged 18 to 70 who have alcohol-related liver disease. This Phase 2 study compares GSK4532990 to a placebo to better understand its impact on this condition, focusing on liver health and related symptoms. Participants will receive either GSK4532990 or a placebo during the study. The treatment is given under double-blind conditions, meaning neither the participants nor the researchers know who receives the drug or placebo. The study aims to find the appropriate dose and assess its effect on liver stiffness and disease severity over a period of up to 52 weeks. During the study, participants will be monitored for any side effects or serious health events for up to 8 weeks. Researchers will also track changes in liver stiffness using FibroScan and measure liver disease severity with a specific score at the start and after 52 weeks. Regular checks of vital signs, lab tests, and heart monitoring will be done to ensure safety throughout the study.

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.