Bahcelievler

Researchers are evaluating the safety and effectiveness of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares two doses of NNC0487-0111 given as weekly injections under the skin against a placebo, with the goal of helping participants lose weight and reduce knee pain. Participants have knee osteoarthritis confirmed by clinical and radiographic criteria and will follow a reduced-calorie diet and increased physical activity throughout the study. Participants will be randomly assigned to receive one of three treatments NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, or a placebo, all given once weekly by subcutaneous injection using a pre-filled pen injector. The injections will be administered to the thigh, abdomen, or upper arm. All participants will be encouraged to follow a reduced-calorie diet and increase physical activity during the trial. The treatment period lasts for 80 weeks. Throughout the study, participants will have regular assessments of body weight, knee pain, physical function, and other health measures. Researchers will collect data on changes in weight, knee pain scores using the WOMAC index, physical function, blood pressure, cholesterol levels, blood sugar markers, and use of pain medication. Safety will be monitored through reporting of adverse events. The study is expected to continue until August 2028, with visits and evaluations occurring at scheduled intervals during the treatment period.

Researchers are evaluating the safety and effects of NNC0487-0111 in adults with excess body weight and knee osteoarthritis. This study compares the active treatment with a placebo injection given once weekly. The goal is to assess weight loss and pain reduction over a long-term period, as well as other health measures related to osteoarthritis and metabolic health. Participants are randomly assigned to receive one of two dose levels of NNC0487-0111 or a placebo injection, both administered under the skin once a week. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment period lasts up to 80 weeks, during which participants follow the specified lifestyle changes. Throughout the study, participants will have regular assessments including body weight, knee pain and function scores WOMAC, physical functioning, blood pressure, cholesterol levels, blood sugar control HbA1c and fasting glucose, and use of pain medications. Safety events and adverse reactions are monitored up to week 84. Participants will be followed closely with these measurements to evaluate the treatments impact and overall safety.

Researchers are studying how weight-bearing exercises like running, jumping, and whole-body vibration affect bone health and the nervous systems role in these benefits, especially relating to osteoporosis in postmenopausal women. The study focuses on two neuromodulatory mechanisms that may explain these effects spinal reflexes from muscle spindles and the bone myoregulation reflex BMR controlled by load-sensitive bone cells called osteocytes. The goal is to understand if reflex control during exercise is mainly driven by bone cells rather than muscle sensors, which could differ in women with osteoporosis due to reduced osteocyte function. Participants will be divided into two groups those with femoral osteoporosis and those without osteoporosis or osteopenia. During testing, researchers will measure the H-reflex amplitude under six different mechanical loading conditions, including standing on one leg with varied weight percentages and during whole-body vibration at different frequencies. Surface EMG signals, force from the heel, and reflex responses will be recorded using specialized equipment. Whole-body vibration will also be applied to assess the bone myoregulation reflex latency. Participants will stand and place specific amounts of weight on their right leg while researchers measure reflex responses and muscle electrical activity. The study will include data collection with electrodes, accelerometers, and force sensors, with careful skin preparation for accurate signals. Researchers will analyze reflex amplitudes and muscle activity during different loading and vibration conditions. Safety and eligibility will be monitored, and the primary outcome is the H-reflex amplitude measured during the testing day, with bone myoregulation reflex latency as a secondary outcome. The study is expected to run until April 2026.

Researchers are evaluating the combination of brenetafusp IMC-F106C plus nivolumab compared to standard nivolumab regimens in people with previously untreated advanced melanoma who are HLA-A*0201-positive. This phase 3, randomized, controlled study aims to understand how these treatments perform in this specific group. The study focuses on improving progression-free survival and overall outcomes for participants with advanced melanoma. Participants are assigned to one of three groups one group receives a low dose of brenetafusp once weekly for 13 weeks, then every two weeks until Week 51, and every four weeks thereafter, along with nivolumab every four weeks another group receives a high dose of brenetafusp on the same schedule plus nivolumab the third group receives nivolumab alone or nivolumab combined with relatlimab every four weeks. The study includes a dose recommendation phase with changes made in November 2025 based on safety and efficacy data. During the study, participants undergo assessments including tumor measurements per RECIST 1.1, BRAF V600 mutation status evaluation, and performance status scoring. Researchers will monitor progression-free survival up to approximately 45 months, overall survival up to 57 months, and record adverse events, immune responses, and quality of life. The study involves regular dosing and long-term follow-up to evaluate treatment effects and safety.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating the efficacy and safety of givinostat compared to hydroxyurea in patients with high-risk polycythemia vera PV who have the JAK2V617F mutation. PV is a chronic blood disorder that increases the risk of blood clots, progression to myelofibrosis, and transformation into acute leukemia. Patients aged 60 or older or those with a prior thrombotic event are considered high risk. Current treatments with hydroxyurea often do not fully control symptoms or long-term risks. Participants will be randomly assigned to receive either oral givinostat at 50 mg twice daily or hydroxyurea at 500 mg twice daily for 48 weeks. Dosages may be adjusted based on side effects or lack of effectiveness. After this core treatment phase, eligible patients can enter an extended treatment phase to receive long-term givinostat, allowing collection of additional safety and efficacy data. Throughout the study, participants will have regular visits to monitor blood counts, spleen size, and treatment responses. Researchers will assess the proportion of patients achieving a response at week 48, including complete hematological response and spleen size normalization. Safety and tolerability will be evaluated up to week 48. The study aims to collect comprehensive data on treatment effects and patient outcomes over time.