Izunokuni

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

This trial investigates the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. It compares the effects of empasiprubart and intravenous immunoglobulin IVIg to evaluate which treatment may better reduce symptoms and improve function in people with CIDP. The study is a Phase 3, randomized, double-blind trial designed to assess both efficacy and safety of these treatments over an extended period. Participants are randomly assigned in Part A to receive either empasiprubart with a placebo resembling IVIg or IVIg with a placebo resembling empasiprubart for 24 weeks 6 months. After Part A, all participants enter Part B, where they receive empasiprubart for an additional 96 weeks 24 months. During Part B, those previously receiving empasiprubart continue with it, and those initially on IVIg switch to empasiprubart. Treatments are administered by intravenous infusion using a double-dummy design to maintain blinding. Throughout the study, participants undergo regular assessments of their disability, strength, grip, and quality of life using various scales such as aINCAT, I-RODS, MRC-SS, and others. Safety is monitored by tracking adverse events and antibody formation against empasiprubart. The primary outcome is the reduction of at least one point in the aINCAT score at week 24. Total participation lasts up to 120 weeks, including both treatment periods, with ongoing evaluations to understand the long-term effects of empasiprubart.

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 includes patients rolling over from a previous study and those needing upgrades from single-chamber to dual-chamber pacemakers. The study focuses on people implanted with leadless pacemakers in the right atrium or ventricle. Participants will receive one of several device-based interventions depending on their group new dual-chamber leadless pacemaker implants with devices placed in the right ventricle and right atrium single-chamber atrial leadless pacemaker implants upgrades involving adding a second leadless pacemaker to form a dual-chamber system or ongoing follow-up for patients already implanted with the Aveir DR leadless pacemaker. Patients are registered and followed until the last new dual-chamber patient reaches three years of follow-up. During the study, patients will be monitored for safety outcomes over 36 months. Data from different patient groups will be analyzed separately. Participants will have ongoing follow-up visits and evaluations to assess the performance and safety of their leadless pacemaker systems. The trial will continue until all new dual-chamber patients complete three years of observation to gather long-term safety information.

Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.

Researchers are evaluating the effects of early treatment with finerenone in patients hospitalized with acute heart failure AHF who have a left ventricular ejection fraction of 40% or more. This phase 4, randomized, double-blind, placebo-controlled trial aims to determine whether starting finerenone during the early phase of hospitalization improves outcomes compared to placebo. Participants are randomly assigned to receive either finerenone or a matching placebo orally. The dosing of finerenone depends on kidney function for those with an eGFR of 60 mLmin1.73 m or less, dosing starts at 10 mg once daily up to 20 mg for those with an eGFR above 60 mLmin1.73 m, dosing starts at 20 mg once daily up to 40 mg. The study treatment is initiated within 36 hours of hospital admission, with randomization occurring within 24 hours. During the study, participants are monitored up to 12 weeks for a composite outcome of death and worsening heart failure, with assessments including heart failure rehospitalization, changes in heart failure symptoms, and biomarker levels such as NT-proBNP. Additional evaluations cover urine output, dyspnea, atrial fibrillation symptoms, and quality of life via questionnaires. Safety and efficacy are closely observed throughout the treatment and follow-up period.

Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.

Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in osteoporotic women who have already had an initial hip fracture and surgery. This randomized controlled trial involves postmenopausal women aged 65 to 91 years who experienced a low-energy fragility hip fracture. The study aims to reduce the chance of a second hip fracture by comparing the new treatment to standard care alone. Participants will be randomly assigned to one of two groups the treated group receives standard hip fracture repair plus the AGN1 LOEP procedure on the opposite unfractured hip, while the control group receives standard repair without the AGN1 LOEP treatment. The AGN1 LOEP procedure involves injecting implant material into the unfractured hip immediately after surgery. This study is single-blinded, except in Canada where it is not blinded. Participants will attend scheduled follow-up visits at 6 weeks, 6 months, and every 6 months thereafter for at least 5 years. During these visits, researchers will monitor for new hip fractures, adverse events, and measure bone mineral density at 12 and 24 months. The study will assess the cumulative incidence of secondary hip fractures and safety outcomes over time, with a minimum follow-up of 5 years after the initial hip repair surgery.