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Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

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 combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the effects of early treatment with finerenone in patients hospitalized with acute heart failure AHF who have a left ventricular ejection fraction of 40% or more. This phase 4, randomized, double-blind, placebo-controlled trial aims to determine whether starting finerenone during the early phase of hospitalization improves outcomes compared to placebo. Participants are randomly assigned to receive either finerenone or a matching placebo orally. The dosing of finerenone depends on kidney function for those with an eGFR of 60 mLmin1.73 m or less, dosing starts at 10 mg once daily up to 20 mg for those with an eGFR above 60 mLmin1.73 m, dosing starts at 20 mg once daily up to 40 mg. The study treatment is initiated within 36 hours of hospital admission, with randomization occurring within 24 hours. During the study, participants are monitored up to 12 weeks for a composite outcome of death and worsening heart failure, with assessments including heart failure rehospitalization, changes in heart failure symptoms, and biomarker levels such as NT-proBNP. Additional evaluations cover urine output, dyspnea, atrial fibrillation symptoms, and quality of life via questionnaires. Safety and efficacy are closely observed throughout the treatment and follow-up period.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

Researchers are evaluating the safety and effectiveness of JX10 compared to a placebo in adults aged 18 to 90 who have experienced an acute ischemic stroke and present for care between 4.5 to 24 hours after stroke onset. The study aims to determine if JX10 improves functional outcomes measured by the modified Rankin Scale and to assess the risk of symptomatic intracranial hemorrhage. This is a multicenter, double-blind, randomized, placebo-controlled study sponsored by Corxel Pharmaceuticals, conducted in phases 2 and 3. Participants in Part 1 are randomly assigned to receive either JX10 at doses of 1 mgkg or 3 mgkg, or a placebo. In Part 2, participants receive the optimal JX10 dose selected from Part 1 or a placebo. The treatment involves intravenous administration of a thrombolytic agent, JX10, designed to improve blood flow by dissolving clots. The study uses a quadruple masking design to ensure unbiased results. Throughout the study, participants will be monitored and assessed for functional recovery using the modified Rankin Scale at 90 days, with safety evaluations including the incidence of symptomatic intracranial hemorrhage within 36 hours post-treatment. Additional assessments include adverse events, serious adverse events, and major bleeding occurrences within 24 hours and up to 14 days after treatment. Total participation spans at least 90 days, during which clinical and radiographic evaluations will be conducted to track progress and safety.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.