Bucheon

This research aims to evaluate the long-term safety of ALLO-ASC-DFU treatment in people who previously participated in a phase 3 clinical trial for Diabetic Foot Ulcer. ALLO-ASC-DFU is a hydrogel sheet containing stem cells from donated fat tissue that may help reduce inflammation and support wound healing. The study focuses on safety outcomes over a 24-month follow-up period. Participants in this open-label follow-up were previously treated with either the ALLO-ASC-DFU sheet or a Vehicle sheet during the earlier phase 3 trial. There is no new treatment given in this follow-up. The study observes the participants who received these treatments to monitor for any safety concerns over two years. During the study, researchers will monitor participants for abnormal lab test results up to 9 months, changes in physical exams and vital signs up to 18 months, and any local reactions at the treatment area up to 24 months. They will also track any adverse events throughout the 24 months. Participants will be involved in regular assessments to evaluate these safety outcomes under medical supervision.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

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 the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and efficacy of NS101, an anti-FAM19A5 antibody, in both healthy volunteers and patients with sudden sensorineural hearing loss SSNHL. This exploratory Phase 1b2a study aims to determine if multiple doses of NS101 are safe and tolerable and whether the treatment can help restore hearing in SSNHL patients who have not sufficiently improved after standard steroid therapy. The study includes a placebo control and uses a double-blind design to ensure unbiased results. Participants receive NS101 or placebo via intravenous infusion at doses of 15 mgkg or 30 mgkg administered every two weeks. Healthy volunteers receive treatment for 6 weeks, whereas SSNHL patients receive treatment for 12 weeks. The study has four groups two dose levels for healthy volunteers with active and placebo arms, and two groups for SSNHL patients receiving either NS101 or placebo. Treatments are given systematically, and participants are randomly assigned to the groups. Throughout the study, participants undergo frequent safety assessments to monitor changes from baseline at multiple time points, including days and weeks after treatment begins. Pharmacokinetic and immunological tests are also performed to track how the drug behaves in the body and its effects. Researchers measure hearing improvement and monitor tolerability closely. The study is expected to continue until January 2027, with participants involved in regular visits and evaluations during and after treatment.

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.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet Filgotinib Maleate 100 mg and 200 mg in Korean participants using it in real-world conditions. The study focuses on monitoring serious and non-serious adverse events and drug reactions, including unexpected ones, as well as changes in disease activity scores related to rheumatoid arthritis and ulcerative colitis. Participants prescribed Jyseleca according to Korean approved therapeutic indications will be observed without additional intervention. They will be followed for up to 24 weeks or until they stop treatment due to adverse events or other reasons. The study includes adults with rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior treatments. During the study, researchers will track adverse events and reactions from enrollment through 24 weeks. They will also measure changes in disease activity scores at baseline, week 12, and week 24. Participants will have regular monitoring visits as part of their usual care, with data collected about safety and treatment effects. The total participation time is up to 24 weeks.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease ILD linked to connective tissue diseases CTDs such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatments impact on lung disease progression and patient well-being.