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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.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effectiveness and safety of RO7837195 in adults with moderately to severely active ulcerative colitis who have not responded well or tolerated conventional or advanced treatments. This Phase IIb study aims to compare RO7837195 to a placebo during the initial treatment phase and then monitor all participants receiving the active drug to assess clinical remission at 12 weeks. The study includes a screening period lasting up to 5 weeks, followed by a 12-week induction phase where participants receive either RO7837195 or a matching placebo according to a specified schedule. After this induction phase, all participants enter a 40-week active treatment extension where they receive RO7837195 regardless of their earlier response. A safety follow-up period occurs after the last dose to continue monitoring participant health. Participants will undergo assessments throughout the study to measure clinical remission at week 12 and to monitor safety and pharmacokinetics. Researchers will collect data on symptoms, treatment effects, and any side effects experienced. The total participation involves multiple phases designed to carefully evaluate the long-term impact and safety of RO7837195 in ulcerative colitis management.

Researchers are evaluating the effects of different doses of SAR442970 compared to placebo in adults with moderate to severe Crohn's disease. This phase 2b, randomized, double-blind study aims to assess the safety and effectiveness of SAR442970 in treating this condition. Participants must have had Crohn's disease for at least three months and have shown inadequate response or intolerance to previous standard or advanced therapies. Participants will receive either SAR442970 or placebo through subcutaneous injections during the treatment period, which lasts up to 158 weeks. Eligible participants may continue into an open-label long-term extension phase for up to 104 weeks. The study includes three treatment groups to compare different doses of SAR442970 with placebo. Throughout the study, participants will be closely monitored with various assessments to measure their response to treatment, including the percentage achieving endoscopic response by Week 16. Researchers will also monitor safety and collect data over a total duration of up to 168 weeks. Participants will have regular visits for evaluations, including clinical assessments and adherence to treatment protocols.

This research aims to evaluate the effectiveness of different doses of SAR442970 compared to placebo in adults with moderate to severe Ulcerative Colitis. It is a phase 2b, randomized, double-blind study conducted across multiple centers and countries. The study includes participants who have had active Ulcerative Colitis for at least three months and meet specific disease activity criteria measured by the modified Mayo Score. Participants will receive either SAR442970 or placebo through subcutaneous injections. The treatment period can last up to 158 weeks and includes a long-term open-label extension lasting up to 104 weeks for those who qualify. This design allows for assessment of both short-term and longer-term effects of the study drug. Throughout the study, researchers will monitor participants regularly to assess clinical remission using the modified Mayo Score at Week 16 as the primary outcome. Participants will undergo clinical evaluations, endoscopy, and other assessments to track disease activity and safety. The total study duration can extend up to 168 weeks, ensuring thorough long-term observation and safety monitoring.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the investigational drug COR-1167, a corticotropin-releasing factor type 2 (CRF2) peptide agonist, in adults hospitalized with worsening heart failure (WHF). This phase 2, randomized, double-blind, placebo-controlled study aims to assess dose-dependent effects of three doses of COR-1167 in patients requiring urgent intravenous diuretic treatment due to worsening symptoms and volume overload associated with heart failure. The study focuses on patients with recent heart failure hospitalization and risk factors for diuretic resistance. Participants will receive either COR-1167 or placebo as a 28-day treatment. The study compares the effects of different COR-1167 doses against placebo to evaluate improvements in heart failure symptoms and fluid management. The treatment period is followed by monitoring to assess changes in clinical and laboratory measures. This design allows careful evaluation of the investigational drug's impact on heart failure worsening. During the study, participants will be monitored for changes in urine sodium excretion over 24 hours, body weight over 7 days, NT-proBNP levels over 7 days, and quality of life using the Kansas City Cardiomyopathy Questionnaire over 28 days. Imaging will assess left atrial volume index within 2 days. Safety and treatment effects are followed closely, with participants involved for at least 28 days during the treatment and assessment periods.