Izunokuni

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.

This research aims to collect safety information on the Aveir DR leadless cardiac pacemaker system in patients who need new dual-chamber pacing. It also gathers data from patients rolling over from a previous Aveir DR i2i IDE study, those with a single-chamber atrial pacemaker, and patients who require an upgrade from a single-chamber to a dual-chamber leadless pacemaker system. The focus is on monitoring safety over a 36-month period. Participants will receive one of several treatments involving the Aveir leadless pacemaker system. Some will have a dual-chamber system implanted, with pacemakers placed in both the right ventricle and right atrium. Others will receive a single-chamber pacemaker implanted in the right atrium. Patients with an existing single-chamber pacemaker may undergo an upgrade by adding a second pacemaker to create a dual-chamber system. Additionally, patients with an active dual-chamber system from the previous study may join the ongoing surveillance phase. During the study, participants will be followed for safety outcomes related to the pacemaker system over 36 months. Data collected will focus on monitoring the safety of these devices in real-world use, including any complications or issues. Enrollment includes new implants, upgrades, and continued follow-up of previous study patients to ensure comprehensive safety surveillance.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are investigating the effects of starting finerenone treatment early during hospitalization for patients with acute heart failure who have a left ventricular ejection fraction of 40% or higher. This Phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether early use of finerenone can improve outcomes in this patient group. Participants are randomly assigned to receive either finerenone or a matching placebo tablet. The finerenone dosing depends on kidney function: patients with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m² or less start at 10 mg once daily, with a maximum dose of 20 mg once daily; those with eGFR above 60 mL/min/1.73 m² start at 20 mg once daily, with a maximum dose of 40 mg once daily. Treatment begins within 36 hours after hospital admission, with randomization occurring within 24 hours. During the study, participants will be monitored for up to 12 weeks to evaluate a combined outcome of death and worsening heart failure. Researchers will conduct assessments including physical exams, symptom evaluation, laboratory tests, and heart function measurements. Safety and adherence to treatment will be tracked throughout the study, ensuring comprehensive evaluation of the therapy's impact during the critical early phase of hospitalization.

Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in women with osteoporosis who have recently had a hip fracture repaired. This randomized controlled trial involves up to 2400 postmenopausal women aged 65 to 91 years who have experienced a low-energy fragility hip fracture and are undergoing surgical repair. The study aims to reduce the incidence of new fractures on the opposite hip, which is at risk during recovery. Participants are randomly assigned to one of two groups: the treated group receives standard hip fracture repair plus the AGN1 LOEP treatment on the unfractured opposite hip, while the control group receives only the standard repair without the AGN1 procedure. The AGN1 LOEP treatment involves injecting the implant material at the treatment site immediately after hip surgery. Follow-up visits are scheduled at 6 weeks, 6 months, and then every 6 months for at least 5 years to monitor outcomes. During the study, participants will undergo assessments to track the occurrence of secondary hip fractures and any adverse events, including serious complications. Researchers will collect data at multiple visits to evaluate the procedure's safety and effectiveness over time. The main outcomes measured include the cumulative incidence of new hip fractures and adverse events approximately 30 months after treatment, with long-term follow-up continuing for a minimum of five years.