Blackfoot

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are studying the effects and safety of different doses of a new medicine called NNC0662-0419 in people with type 2 diabetes. This study compares NNC0662-0419 with semaglutide, an approved diabetes medication, and a placebo to find out if NNC0662-0419 is an effective and safe treatment option. Participants will be randomly assigned to receive one of these treatments. Participants will receive their assigned treatment by weekly injections under the skin. The study includes groups receiving NNC0662-0419 with increasing doses, semaglutide, or placebo matched to the investigational medicines. Treatments will be given once a week during the study period. During the study, participants will have their blood sugar control monitored by measuring glycated hemoglobin HbA1c at various time points up to 40 weeks. Researchers will also track changes in body weight, blood sugar levels, cholesterol, kidney function, and the number of adverse events. The study lasts until about 48 weeks, allowing for safety and effectiveness assessments throughout this time.

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 immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the safety and immune response of a new pneumococcal vaccine called PG4 in children and adolescents aged 15 months to 18 years. It compares this new vaccine to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC, focusing on how both vaccines help protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study is a phase 3 trial conducted internationally, including the United States and Puerto Rico. Participants are divided into three age groups 15 months to less than 2 years, 2 years to less than 5 years, and 5 years to less than 18 years. Within each group, participants are randomly assigned in a 21 ratio to receive a single injection of either the new PG4 vaccine or the 20vPnC vaccine. The vaccine is administered intramuscularly in the arm or thigh. The study lasts about 6 months and involves 2 clinic visits and 1 telephone follow-up. During the clinic visits, blood samples are taken to measure immune responses and participants are monitored for any side effects or adverse events. Researchers assess local and systemic reactions within 7 days after vaccination, adverse events up to 1 month, and serious adverse events up to 6 months after vaccination. The main outcomes include measuring specific antibody levels to evaluate the immune response. Participants are contacted by phone for a follow-up to check for any further side effects, ensuring ongoing safety monitoring throughout the study.