Matsudo

This research aims to evaluate the safety and effectiveness of a drug called DII235 in adults who have high levels of lipoprotein(a), a condition linked to lipoprotein disorder. The study focuses on adults aged 18 to 80 years who also have evidence of atherosclerotic cardiovascular disease or type 2 diabetes. This is a Phase 2 study designed to identify the best dose of DII235 and understand its impact on lipoprotein(a). Participants will be randomly assigned to receive either DII235 or a placebo in a controlled, double-blind manner to ensure unbiased results. The study involves administering DII235 or a saline placebo as solutions for injection. The trial is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study. Participants will receive different doses of DII235 or the placebo, and their responses will be compared over time to evaluate the drug's effects on lipoprotein(a) levels. The dosing and treatment schedules are carefully monitored to assess the safety, tolerability, and appropriate dosage levels of DII235. Participants will be followed and evaluated through various assessments, including measuring the percentage change from their baseline lipoprotein(a) levels between Day 60 and Day 180, and also between Day 60 and Day 360 for different doses. Safety and tolerability will be closely monitored throughout the study duration. The trial includes regular laboratory testing and clinical evaluations to track participant health and treatment response. Overall participation in the study spans several months to capture both short-term and longer-term effects of the treatment.

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating the safety and effectiveness of surgical aortic valve replacement (SAVR) compared to transcatheter aortic valve replacement (TAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This prospective, randomized, controlled, multi-center study aims to determine if SAVR is not inferior to TAVR in terms of death from any cause, stroke, and rehospitalization related to valve procedures within one year after surgery. Participants will be randomly assigned to receive either SAVR or TAVR using commercially available surgical and transcatheter bioprosthetic valves. The study includes follow-up visits at hospital discharge, 30 days after the procedure, and then annually for up to 10 years to monitor outcomes and safety. Both procedures involve valve replacement but differ in their surgical approach. During the study, participants will undergo assessments to track mortality, stroke events, and hospital readmissions related to valve or procedure complications. Researchers will collect clinical data and monitor participants regularly over the long-term follow-up period to evaluate the combined primary endpoint at one year post-procedure and observe ongoing safety and effectiveness.

Researchers are evaluating the effectiveness and safety of a Double-effect kissing balloon technique (W-KBT) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) who have left circumflex artery (LCx) ostium stenosis. This is a prospective, observational, multi-center study focusing on patients with stable angina, non-ST-elevation acute coronary syndrome, or unstable angina who are undergoing percutaneous coronary intervention (PCI). Patients who meet selection criteria will be enrolled and treated under usual care. The PCI procedure involves W-KBT following crossover stenting for the left main trunk to left anterior descending artery direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) as the optimal treatment. Operators will obtain consent before performing PCI and will register cases continuously to assess the technique's efficacy and safety. Participants will undergo PCI with W-KBT, and data will be collected during the procedure to measure procedure success rates. Researchers will monitor major adverse cardiovascular events (MACE) within 12 months after PCI. The study will gather real-world data from multiple centers to evaluate the outcomes and safety of this treatment approach over time.

Researchers are evaluating the safety and effectiveness of two treatment approaches following Left Atrial Appendage Closure (LAAC) in people with non-valvular atrial fibrillation who have a high risk of bleeding. This Phase 4 clinical trial compares Non-Antithrombotic Therapy (NAPT), where patients receive oral anticoagulants (OAC) for 45 days followed by no further antithrombotic treatment, to Single Antiplatelet Therapy (SAPT), which involves OAC for 45 days followed by low-dose aspirin. The main goal is to determine if NAPT is not worse than SAPT in preventing serious events like death, heart attack, stroke, systemic embolism, or major bleeding over a maximum of four years. Participants will be randomly assigned to either the NAPT or SAPT group after LAAC. Both groups start OAC treatment within 24 hours of enrollment and continue for 45 days. After this period, the SAPT group will take low-dose aspirin for the remainder of the study, while the NAPT group will stop all antithrombotic medications. The study includes visits at 45 days, 1 year, and 2 years post-enrollment, with additional follow-up by phone up to four years. During the study, participants will be monitored for health events such as mortality, heart attacks, strokes, and bleeding complications. Assessments include hospital visits and telephone check-ins to track outcomes and safety throughout the observation period. The total follow-up time for each participant can be up to four years, ensuring close monitoring over the long term.

Researchers are evaluating multiple investigational compounds in adults with moderate to severe atopic dermatitis (AD) in this multicenter, randomized, double-blind, placebo-controlled Phase II platform study. The study aims to assess the efficacy and safety of these compounds, with the first intervention being GHZ339. Participants will be randomly assigned to receive one of the study treatments. The trial compares different doses of GHZ339 against a matching placebo. Participants will receive assigned treatments during the study period, with dosing details including several dose levels labeled A, B, C, and D for GHZ339. The design allows evaluation of treatment effects on moderate to severe AD symptoms. Participants will be involved in the study from baseline through Week 16, with assessments including the Eczema Area and Severity Index (EASI) score measured to track changes from baseline. Safety and efficacy will be monitored throughout the trial, and all participants must meet specific inclusion criteria including an AD diagnosis for at least one year and moderate to severe disease. The total duration of participation spans at least 16 weeks for outcome measurement.