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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 conducting two related studies called RADICAL PC1 and RADICAL PC2 focused on men diagnosed with prostate cancer. RADICAL PC1 follows men within one year of their prostate cancer diagnosis or who have recently started androgen deprivation therapy (ADT). The goal is to understand factors linked to developing cardiovascular disease in these men, especially related to ADT. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that tests a systematic approach to improving heart health and lifestyle risk factors in this population. The treatments studied include behavioral advice on healthy nutrition, exercise including strength and resistance training, and smoking cessation support if needed. Drug treatments include prescriptions of low to moderate dose statins and ACE inhibitors or angiotensin receptor blockers for controlling blood pressure above 130 mmHg. The intervention targets men newly diagnosed or recently starting ADT, and treatment is personalized based on cardiovascular risk. Participants engage in assessments to monitor heart-related outcomes such as death, heart attacks, strokes, heart failure, or arterial revascularization over 3 to 5 years. The study tracks cardiovascular health and lifestyle factors throughout this period to evaluate the effectiveness of the interventions. Safety and progress are closely monitored to understand impacts on long-term outcomes in men with prostate cancer undergoing ADT.

Researchers are evaluating the safety and effectiveness of the drug baricitinib in children aged 1 year to less than 18 years who have systemic juvenile idiopathic arthritis (sJIA), a type of arthritis that affects the joints and causes inflammation. This Phase 3 study includes two groups of participants: one group receives either baricitinib or tocilizumab, and the other group receives only baricitinib. The study aims to understand how well baricitinib works compared to tocilizumab and to monitor its safety in young patients. Participants in the study are assigned to one of two cohorts. Cohort 1 includes children who have not previously received IL-6 inhibitor therapy and will be treated with either baricitinib, taken by mouth, or tocilizumab, given by subcutaneous injection. Cohort 2 includes children who will receive baricitinib alone. The treatments are administered according to the study plan, and participants are monitored throughout the treatment period. During the study, researchers will assess participants' joint activity and overall response to treatment by measuring the percentage who meet specific improvement criteria after 12 weeks. Participants will undergo regular evaluations including physical exams and safety monitoring. The study also closely watches for any side effects or infections. The total duration of participation includes the treatment period and follow-up assessments to ensure comprehensive evaluation of baricitinib's effects in children with sJIA.

Researchers are evaluating the long-term safety and effectiveness of baricitinib for treating Juvenile Idiopathic Arthritis (JIA) in children and teenagers aged 1 to less than 18 years. This phase 3 study focuses on participants who have previously taken part in baricitinib studies I4V-MC-JAHV or I4V-MC-JAHU. The goal is to monitor how well baricitinib works and how safe it is over an extended period in this young population. Participants will receive baricitinib orally as part of the study treatment. Since all participants have prior exposure to baricitinib in earlier studies, this trial continues to observe their response and any long-term effects. The study does not mention a separate comparator group or additional interventions beyond baricitinib administration. During the study, researchers will track serious adverse events and any permanent discontinuations of baricitinib from the start through week 264. Participants will be regularly monitored for safety and treatment effects throughout this long-term follow-up. This extended observation helps assess the ongoing impact of baricitinib on juvenile arthritis over several years.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the effectiveness and safety of pirtobrutinib (LOXO-305) compared to ibrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study includes participants who may have had prior treatment as well as treatment-nave participants with a specific genetic deletion (17p deletion). The study is a Phase 3, open-label, randomized trial designed to assess these treatments in different patient groups over varying durations. Participants receive either oral pirtobrutinib or oral ibrutinib. Part 1 compares these two drugs in participants with or without prior therapy, and participation can last up to six years. Part 2 focuses on pirtobrutinib alone in treatment-nave participants with 17p deletions, with participation lasting up to two years. The study carefully monitors responses to treatment, including complete and partial remissions. Throughout the study, participants undergo regular assessments to track their response to therapy, including measuring overall response rates from the start of treatment until disease progression or new treatments begin. Safety and organ function are monitored, and laboratory tests help evaluate blood counts and kidney function. The study aims to provide detailed information on how well the treatments work and their safety over the long term.

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.

Researchers are evaluating the safety and effectiveness of combining vedolizumab with upadacitinib, called dual targeted therapy (DTT), compared to using vedolizumab alone (monotherapy) in adults with moderately to severely active Crohn's Disease. The main goal is to see if DTT better reduces bowel inflammation and ulcers after 12 weeks of treatment. This Phase 3b trial involves about 396 participants worldwide and also aims to assess the long-term safety and efficacy of these treatments. Participants are randomly assigned in equal numbers to receive either vedolizumab plus upadacitinib or vedolizumab plus placebo during a 12-week induction phase. Those who respond well, showing a significant reduction in disease activity, then continue to a 40-week maintenance phase receiving vedolizumab alone. After this, participants undergo an 18-week safety follow-up period, making the total study participation approximately 70 weeks. During the study, participants will visit the clinic 15 times for assessments including evaluations of disease activity, endoscopic examinations, and safety monitoring. The main outcome measures include the percentage of participants achieving clinical remission and showing improvement in bowel inflammation at Week 12. Researchers will track effectiveness, adverse effects, and overall health throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.