Baguio

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 orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in hospitalized adults with severe community-acquired pneumonia sCAP who require invasive mechanical ventilation IMV. This phase III, randomized, placebo-controlled, double-blind study aims to compare trimodulin plus standard care against placebo plus standard care. The study also investigates detailed pharmacokinetic and pharmacodynamic properties of trimodulin. Participants will be randomly assigned to receive either trimodulin a human immunoglobulin solution containing IgM, IgA, and IgG or a placebo human albumin 1% via intravenous infusion once daily for five consecutive days alongside standard care. After treatment, participants will enter a follow-up phase lasting up to 23 days, including an end-of-follow-up visit or phone call on day 29. If still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a closing visit or call around day 91. During the study, participants undergo various assessments including monitoring of mortality rates up to 28 and 90 days, changes in organ failure scores, clinical cure of pneumonia, ventilator and oxygen use, ICU and hospital stay durations, readmission rates, adverse events, lab tests, electrocardiograms, and vital signs. Safety evaluations and outcome measurements occur throughout treatment and follow-up, with total participation lasting up to approximately 90 days.

Researchers are studying ziftomenib, an investigational drug targeting the menin pathway, in patients with acute myeloid leukemia AML who have specific genetic mutations NPM1-m or KMT2A-r and have not yet received treatment. The study includes two separate phase 3, randomized, double-blind, placebo-controlled trials assessing ziftomenib combined with standard therapies. The goal is to evaluate the benefits and risks of adding ziftomenib to current standard treatments for AML. One study, called the Nonintensive Therapy Study, enrolls older patients or those with serious medical conditions to receive venetoclax and azacitidine standard care plus either ziftomenib or placebo. The second study, the Intensive Therapy Study, involves medically fit patients treated with cytarabine and daunorubicin known as 73 plus ziftomenib or placebo during induction, followed by cytarabine plus ziftomenib or placebo in consolidation, and a maintenance phase where patients receive ziftomenib or placebo alone. Patients are randomly assigned to these groups without knowing which treatment they receive. Participants will undergo regular assessments to monitor overall survival, event-free survival, remission rates, and measurable residual disease in bone marrow up to 36 months after enrollment. Safety is evaluated through adverse event reporting and drug concentration measurements. Patient-reported outcomes related to health are also collected. The study involves oral and intravenous drug administration with visits scheduled according to treatment phases. Participation lasts up to 36 months, including treatment and follow-up periods.