Shimonoseki

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the effects of Pemafibrate, given at doses of 0.2 mgday or 0.4 mgday, in patients with hypercholesterolemia who do not respond adequately to statin therapy. This post-marketing Phase 4 clinical trial compares these doses to a placebo to assess efficacy and safety over 12 weeks. The study aims to understand how Pemafibrate impacts cholesterol levels, particularly LDL-C, in this patient group. Participants will be randomly assigned to receive either Pemafibrate at one of the two doses or a placebo, all administered orally once daily for 12 weeks. The trial uses a double-blind, parallel group design, meaning neither participants nor researchers know who receives which treatment. The treatment period is structured to monitor changes in cholesterol levels at multiple time points during the 12 weeks. During the trial, participants will have their LDL-C levels measured at baseline and at 4, 8, and 12 weeks after starting the medication. Additional lipid markers will also be assessed at these times. Safety and response to treatment will be closely monitored, including achievement of lipid management goals. The total participation time covers the 12-week treatment phase with scheduled visits and assessments throughout.

Researchers are evaluating a potential new medicine called CDR132L to understand its effects on the structure and function of the heart in people living with heart failure. The study focuses on participants with heart failure who have reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This research is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aiming to assess safety and efficacy in this population. Participants will receive an intravenous infusion of either CDR132L or a placebo once every four weeks for 48 weeks. Alongside this, all participants will continue their individually tailored guideline-directed standard of care therapy for heart failure. The studys main phase covers these 48 weeks of treatment, followed by monitoring adverse events up to week 60. During the approximately 60-week study, participants undergo evaluations including echocardiography and blood tests measuring biomarkers like microRNA-132-3p and NT-proBNP. Researchers will track changes in heart structure and function, adverse events, and safety throughout the study. The primary outcome focuses on changes in normalized microRNA-132-3p levels from baseline to week 24, while secondary outcomes include measures of heart volume and biomarkers, plus adverse event counts.

This research aims to evaluate 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. The study compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are studying the drug JNJ-88545223 to see how well it works compared with a placebo in adults who have active psoriatic arthritis PsA. This study aims to determine if JNJ-88545223 can reduce the signs and symptoms of PsA and improve the health of joints and skin. The trial is a randomized, double-blind phase 2b study designed to evaluate different doses of the drug. Participants will be randomly assigned to receive one of four treatments from Week 0 to Week 16 placebo, or one of three doses of JNJ-88545223. Each group will receive their assigned treatment under blinded conditions to compare the effects. The study focuses on evaluating the efficacy and safety of these doses over the 16-week treatment period. During the study, participants will undergo regular assessments to measure treatment effects, including the American College of Rheumatology ACR 50 response at Week 16 as the primary outcome. Additional evaluations include skin severity indexes PASI responses, physical function questionnaires, and quality of life surveys. Safety and symptoms will be monitored throughout the trial, which lasts approximately 16 weeks for each participant.

Researchers are evaluating the safety, tolerability, and effectiveness of apraglutide compared with a placebo in adults with short bowel syndrome associated with intestinal failure SBS-IF. This Phase 3, double-blind, randomized, placebo-controlled study aims to include about 124 adult participants who rely on parenteral support PS at least three days per week. Participants are stratified by anatomy and baseline PS volume to ensure balanced study groups. Participants will be randomly assigned to receive either weekly subcutaneous injections of apraglutide or placebo for 24 weeks. The study consists of four periods Screening including optimization and stabilization, Treatment, Safety Follow-up after the last dose, and an Anti-Drug Antibody Follow-up period. Those completing treatment may join a long-term extension study with apraglutide or complete a safety follow-up visit before entering the antibody monitoring phase. During the study, participants will have their weekly parenteral support volume measured to assess changes. Additional assessments include reductions in PS days per week, achievement of enteral autonomy, and patient-reported global impression of change. Safety will be monitored through adverse event tracking and laboratory tests. Participants are expected to adhere to fluid intake monitoring and may undergo colonoscopy or imaging to remove any polyps. The entire participation timeline extends beyond treatment to ensure thorough safety and immune response evaluation.