Meguro City

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

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, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are conducting a Phase 3 pediatric study to create a framework for evaluating the safety and effectiveness of drugs for managing obesity or overweight conditions in children and teens. The study focuses on participants who have struggled to lose weight despite structured diet and exercise programs. The goal is to assess treatments for long-term weight management in this young population. Participants will receive either the study drug Orforglipron or a placebo orally. The interventions will be detailed in specific substudies, called ISAs, which may start independently as new treatments become available. Results from all ISAs will be reported once all are completed, providing insights into the treatments effects on pediatric obesity or overweight. During the study, participants will be evaluated from baseline to week 72, with the primary outcome measuring the number of participants assigned to each ISA. Participants will undergo assessments including body mass index evaluations based on age- and gender-specific growth charts, and monitoring for weight-related health conditions. Safety and efficacy data will be collected throughout the study duration, which extends to March 2027.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the effects of orforglipron, taken once daily by mouth, compared to placebo in adolescents aged 12 to 17 years who have obesity or are overweight with related health conditions. The study aims to assess the drugs efficacy, safety, and how it is processed by the body. This phase 3 trial is conducted under a master protocol and sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either orforglipron or a placebo orally once daily. Those who complete the initial PW01 study, including a safety follow-up period, may continue receiving orforglipron for an additional 156 weeks while maintaining lifestyle interventions such as diet and exercise counseling. The trial follows a double-blind design where neither participants nor researchers know the assigned treatment. During the roughly 18-month participation, adolescents will undergo regular assessments including body mass index BMI, body weight, waist circumference, blood pressure, cholesterol, glucose levels, insulin levels, body fat mass via DXA scans, and quality of life related to weight impact. Pharmacokinetic measurements will also be taken to study the drugs concentration over time. Safety and effectiveness will be monitored through these evaluations at baseline and at Week 72.

Researchers are evaluating pasritamig JNJ-78278343 combined with best supportive care BSC compared to placebo with BSC in men with metastatic castration-resistant prostate cancer mCRPC, a form of prostate cancer that has spread and no longer responds to hormone therapies. This Phase 3 randomized, double-blind study aims to assess overall survival, measuring how long participants live from the start of the study until death from any cause. Participants will be randomly assigned to receive either pasritamig or placebo through intravenous infusion. The dosing starts with step-up doses on Cycle 1 Day 1 and Day 8, followed by a target dose on Day 15. Subsequent cycles of treatment occur every 6 weeks, with Cycle 1 lasting 8 weeks and later cycles lasting 6 weeks each. All participants may also receive best supportive care, which includes treatments like radiation, steroids, pain medication, and other palliative procedures, at the physicians discretion. Treatment continues until disease progression, intolerable side effects, withdrawal, death, or end of study. During the study, participants will have regular assessments to monitor overall survival and other outcomes such as progression-free survival, symptomatic progression, skeletal-related events, and time to pain or fatigue worsening. Laboratory tests and monitoring for adverse events will occur up to 2 years and 8 months. Participants will receive ongoing evaluation to track treatment effects and safety throughout the trial duration, which spans until August 2028.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III study aims to better understand the impact of trontinemab on cognitive decline and daily functioning in this population. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be assigned to receive either intravenous trontinemab or an intravenous placebo. The treatment period lasts up to 72 weeks, during which participants receive infusions as scheduled. Assessments include brain imaging such as amyloid and tau PET scans, cerebrospinal fluid and blood biomarker collection, and cognitive testing. The study also monitors safety through tracking adverse events, infusion-related reactions, and anti-drug antibodies. Participants will attend visits for evaluations including clinical dementia rating, cognitive scales like MMSE and ADAS-Cog-13, and daily living activities assessments. Safety monitoring involves MRI scans and lab tests. The primary outcome measured is the change in Clinical Dementia Rating, Sum of Boxes CDR-SB, from baseline to Week 72. The total duration of participation extends through the 72-week treatment and assessment period, with ongoing safety evaluations.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.