Hakodate

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the disease-free survival in participants with high-risk non-muscle-invasive bladder cancer HR-NMIBC who have previously received Bacillus Calmette-Gurin BCG treatment. This Phase 3 trial compares a new treatment called TAR-210 with the investigators choice of intravesical chemotherapy. The study focuses on participants with specific fibroblast growth factor receptor FGFR alterations and aims to find out which treatment better prevents cancer recurrence or progression after BCG therapy. Participants are randomly assigned to one of two groups. Group A will have TAR-210 inserted into the bladder starting on Day 1 and continuing for about 2 years. Group B will receive either mitomycin C or gemcitabine chemotherapy, chosen by the investigator, given once weekly for 4 to 6 weeks induction, followed by monthly maintenance doses for up to 1 year, with a possible second year of maintenance at the investigators discretion. All treatments are delivered directly into the bladder intravesically. During the study, participants will be monitored for up to 5 years to track disease-free survival and other outcomes such as recurrence-free survival, time to next intervention, disease worsening, progression, and overall survival. Researchers will also assess side effects, laboratory and vital sign changes, and quality of life using specific questionnaires. The study includes regular evaluations and safety monitoring throughout the participation period, which may last several years.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are evaluating the effectiveness and safety of a new oral cladribine formulation in adults with Generalized Myasthenia Gravis gMG. This phase 3 clinical trial compares cladribine to a placebo to understand its sustained benefits, the need for retreatment, and long-term safety. The study also includes a component to analyze how the drug is processed in the body and features interviews to learn about participants experiences with cladribine treatment. The trial is organized into three periods a double-blind placebo-controlled DBPC period where participants receive either placebo or cladribine in two separate oral courses a blinded extension BE period where initial placebo recipients switch to cladribine doses and some receive retreatment if needed and a retreatment RT period where participants may receive additional cladribine or placebo based on clinical need. Doses include low and high oral cladribine, administered as scheduled treatment courses. Participants will undergo various assessments including evaluations of muscle weakness and daily living activities using specific scales like the MG-ADL and QMG. Researchers will monitor safety through tracking adverse events, laboratory tests, and heart monitoring. Pharmacokinetic blood sampling will measure cladribine levels at multiple time points. The study duration extends up to week 144, during which participants responses and safety are closely observed to understand the drugs effects over time.

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

Researchers are evaluating the safety and effectiveness of the 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 prospective, observational, multi-center study focuses on patients with stable angina, non-ST-elevation myocardial infarction, or unstable angina who require percutaneous coronary intervention PCI. Patients who meet the selection criteria will receive PCI with W-KBT following crossover stenting for LMT-LAD direction, proximal optimization technique POT, and conventional kissing balloon technique C-KBT as part of usual care. Approximately 280 participants aged 18 and older will be enrolled across 17 sites in Japan. The study will monitor patients through hospital discharge and for 12 months afterward during routine clinical practice. Participants will be followed to assess procedure success during PCI and major adverse cardiovascular events MACE within 12 months. Additional measures include time to ST-change from DCB inflation, total DCB inflation time, changes in blood pressure and heart rate, use of vasopressors or mechanical support after W-KBT, and incidence of ischemia-driven revascularization at the LCx ostium. Data will be collected to evaluate the efficacy and safety of this treatment approach over the year following the procedure.