Hinesville

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

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.

Researchers are investigating the safety and how the body processes a medicine called Zavegepant (PF-07930207) in children aged 6 to less than 12 years who have a history of migraine lasting at least 6 months. The study focuses on understanding how the medicine is absorbed, changed, and removed by the body in this young population. Participants must weigh more than 15 kilograms to join this Phase 1 study. All children in the study will receive a single dose of Zavegepant as a nasal spray, with the dose depending on their weight (either 5 mg or 10 mg). The medicine is given once by spraying into one nostril. This study is open-label and multicenter, meaning both researchers and participants know what treatment is given, and it is conducted at multiple locations. Participants will be involved for up to 10 weeks, during which they will have three visits to the study clinic and two follow-up phone calls. During these visits, researchers will collect blood samples at specified times to measure how much medicine is in the bloodstream and how quickly it reaches peak levels. They will also monitor safety, tolerability, and any side effects to better understand the medicine's effects in children with migraine.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating the safety and effectiveness of AZD2373 in adults aged 18 to 65 diagnosed with APOL1-Mediated Kidney Disease (AMKD) who carry specific high-risk APOL1 genotypes (G1 and G2). This Phase 2b study aims to see if AZD2373 can reduce the urine albumin-creatinine ratio (UACR) more than a placebo by the 30th week of treatment. Participants must have significant kidney involvement as indicated by UACR and estimated glomerular filtration rate (eGFR) levels. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple treatment groups. The study includes three treatment arms: two different doses of AZD2373 and a placebo, all delivered via accessorized pre-filled syringes as injections. Participants will be randomly assigned to one of these groups and neither they nor the study staff will know their assignment during the trial. Treatment will last for a minimum of 30 weeks, continuing until the last participant completes this period. The study also uses a specialized APOL1 genotyping test to confirm participants' eligibility based on their genetic profile. Participants will undergo screening with urine tests to confirm UACR levels and blood tests for kidney function before joining. During the study, researchers will monitor changes in UACR from baseline to week 30 to assess treatment effects. Safety and tolerability will also be closely observed throughout the treatment period. Around 96 participants will be enrolled, with about 32 in each group, and all will be followed until the last participant completes the 30 weeks of treatment.

Researchers are collecting real-world data on patients with advanced Epidermal Growth Factor Receptor (EGFR)-mutated Non-Small Cell Lung Cancer (NSCLC) who are treated outside of clinical trials. The study aims to better understand the safety and effectiveness of standard care treatments involving osimertinib alone or combined with chemotherapy. This observational study includes patients from both academic and community medical centers to reflect routine clinical practice. The study compares two treatment groups: one receiving osimertinib as a single oral daily dose, and another receiving osimertinib plus chemotherapy, with the chemotherapy regimen chosen by the treating physician. Treatment dosing and administration follow standard care guidelines or institutional protocols. The decision on which treatment a patient receives is made by their doctor and recorded when the patient joins the study. Participants will be followed as per their physician's usual care, including clinical and imaging assessments. Researchers will track progression-free survival, measuring the time from starting therapy until disease progression or death, for up to three years. The study plans to enroll up to 538 patients, with about 250 in each treatment group, to evaluate outcomes and monitor safety in a real-world setting.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.