Asahikawa

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.

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.

Parkinson's disease (PD) is a neurological disorder that affects the brain and causes symptoms like tremors, stiffness, and slow movements. This research aims to evaluate how safe and effective ABBV-951 is when used to treat adults with advanced Parkinson's disease in a real-world setting. ABBV-951 is an approved medication in Japan, and the study will involve about 250 adult participants aged 15 years and older who have been diagnosed with PD and prescribed ABBV-951 by their doctors. Participants will receive ABBV-951 as directed by their physicians over a period of 52 weeks. The study will observe and record any changes in disease activity as well as any adverse events that occur, including monitoring the percentage of participants experiencing infusion site infections during this time. The treatment and follow-up will be conducted either in-person or through virtual visits according to standard care practices. During the study, participants will have regular visits and assessments, which may be conducted on-site or virtually, ensuring minimal additional burden. Researchers will collect data on safety and effectiveness throughout the 52-week period. The study is designed to monitor participants closely while allowing treatment as usual, supporting ongoing evaluation of ABBV-951 in managing advanced Parkinson's disease.

Researchers are evaluating ivonescimab as a first-line treatment option for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors show high PD-L1 expression. This phase 3 randomized, double-blinded study compares ivonescimab with pembrolizumab to assess overall survival and progression-free survival in this patient group. Participants will receive either ivonescimab or pembrolizumab as intravenous injections. The study is designed to monitor these treatments over time to determine which may provide better outcomes in controlling metastatic NSCLC in patients with high PD-L1 levels. The study includes patients with measurable non-brain lesions and no prior systemic treatment for metastatic NSCLC. During the trial, patients will be closely followed for up to approximately 36 months to measure overall survival and progression-free survival. Researchers will assess the safety and effectiveness of the treatments through regular evaluations, including monitoring for disease progression and survival status. This long-term follow-up ensures comprehensive understanding of treatment impact over time.

Researchers are evaluating the safety and effectiveness of rituximab (genetical recombination) given through an intravenous infusion for people with idiopathic membranous nephropathy who also have nephrotic syndrome. This phase 3 study aims to confirm how well rituximab works and how safe it is compared to a placebo. The study focuses on patients aged 15 years and older who meet specific clinical criteria related to their kidney condition and protein levels. Participants will receive either rituximab or a placebo through intravenous infusions given every two weeks for two doses during the double-blind phase. If patients do not show sufficient improvement by week 26, they may enter an open-label phase where they can receive rituximab again if deemed necessary by the investigator. The treatment dosing in the open-label phase is the same as in the initial phase, with two doses of 1,000 mg rituximab given every two weeks. During the study, participants will be monitored to measure the percentage of patients achieving predefined remission criteria by week 26. Assessments will likely include lab tests for protein levels and albumin in the blood, kidney function, and safety evaluations. The study involves informed consent, screening for eligibility, and ongoing monitoring to evaluate treatment response and safety throughout the study period.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.