Lom

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating the safety and effectiveness of contezolid acefosamil (administered intravenously) and contezolid (administered orally) compared to linezolid (administered both intravenously and orally) in adults with moderate or severe diabetic foot infections (DFI). This Phase 3, multicenter, randomized, double-blind study involves approximately 865 adult subjects whose infections are confirmed or suspected to be caused by Gram-positive bacteria. The study focuses on helping understand treatment responses in this population with diabetes-related foot infections. Participants will receive either contezolid acefosamil/contezolid or linezolid for a total treatment duration of 14 to 28 days, with dosing ranging from 28 to 56 doses in total. Both treatments are given through intravenous and oral routes during this period. The study groups are compared for their effects on the infection and safety outcomes during and after this treatment phase. During the study, participants will be monitored for clinical response by assessing the resolution of infection signs and symptoms without needing further therapy by Day 35. Safety evaluations include tracking adverse events reported by participants, clinical laboratory tests such as complete blood counts, and vital signs like heart rate between 28 and 35 days after the end of therapy. This comprehensive monitoring helps assess both the effectiveness and safety of the treatments over the study timeline.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.