Hinesville

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 effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are studying the safety and how the body processes the medicine called Zavegepant PF-07930207 in children aged 6 to less than 12 years who have a history of migraine. The study focuses on understanding how the body changes and removes this medicine after taking it. Participants must have had migraines for at least 6 months and weigh more than 15 kilograms. All children in the study will receive a single dose of Zavegepant as a nasal spray, with the dose depending on their weight. Each participant will get one spray into one nostril. This is an open-label study, meaning everyone receives the study medicine, and the effects of different doses will be observed. The study lasts up to 10 weeks. During the study period, participants will attend 3 clinic visits and have 2 follow-up phone calls. Researchers will monitor the medicines concentration in the blood at specific times after dosing. They will also track any side effects and changes in vital signs, lab results, and mental health. The main outcomes involve measuring how much and how quickly the medicine appears in the blood.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating the effect of the Cost Communication and Financial Navigation CostCOM intervention on adherence to cancer care and financial burden in patients with malignant solid neoplasms. This study focuses on how financial hardship caused by out-of-pocket costs, employment changes, and insurance affects cancer treatment and quality of life. CostCOM aims to provide financial counseling and resource connections to reduce these burdens and improve adherence to care. Participants are randomized into two groups. One group receives a brochure describing financial navigation services Enhanced Usual Care, while the other group receives usual financial care plus CostCOM financial counseling sessions within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants complete surveys and participate in interviews 15 to 39 months after the first patient enrollment. Participants complete surveys at baseline and at 3, 6, and 12 months to report on cost-related care non-adherence, financial hardship, financial worry, quality of life, and satisfaction with care. The study includes follow-up for 12 months after intervention completion. Non-patient participants also provide feedback on the CostCOM intervention through interviews. Researchers will monitor patient experiences and financial outcomes throughout the study.

Researchers are evaluating the efficacy and safety of AZD2373 in adults aged 18 to 70 years with APOL1-Mediated Kidney Disease AMKD who have high-risk APOL1 genotypes G1 and G2. The study aims to determine if AZD2373 reduces urine albumin-to-creatinine ratio UACR more than a placebo by Week 30. This Phase 2b trial involves participants with elevated UACR and adequate kidney function, excluding those on dialysis or with other organ transplants. The study consists of two parts. Part A randomizes participants equally to receive weekly subcutaneous injections of either 50 mg AZD2373, 150 mg AZD2373, or placebo. Part B randomizes participants in a 41 ratio to receive every-other-week injections of 150 mg AZD2373 or placebo, starting after Part A enrollment completes. Participants remain on treatment for a minimum of 30 weeks. After this period, they may enter an open-label extension study. Participants will have regular assessments throughout the study, including urine and blood tests to measure UACR, urine protein-to-creatinine ratio, kidney function eGFR, drug levels, and antibody development. Safety monitoring includes tracking adverse events during treatment and for 12 weeks afterward. These evaluations help assess how the study drug affects kidney disease markers and participant health over the treatment period.

Researchers are evaluating a connected customized treatment platform called CONCURxP to improve medication adherence in patients with metastatic hormone receptor-positive, HER2-negative breast cancer who are taking CDK46 inhibitors. The study compares CONCURxP, which includes the WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. The purpose is to see if these approaches affect how well patients follow their medication schedules, symptom burden, quality of life, and other outcomes over 12 months. Participants are randomly assigned to one of two groups Arm A uses the WiseBag dispenser and receives educational materials every 4 weeks for 12 months, while Arm B uses the WiseBag plus receives personalized text reminders, medication tracking, and provider follow-ups through CONCURxP for 12 months. A third group Arm C involves non-patient participants completing interviews 15 to 39 months after the first patient enrollment. After the 12-month intervention period, patients may be followed for an additional 6 months. During the study, patients complete surveys and electronic monitoring to assess medication adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, and financial worry at multiple time points. Some participants may also complete interviews about their experiences. Researchers review healthcare utilization, progression-free survival, and overall survival at 12 months. The study involves continuous monitoring using the WiseBag device and regular follow-ups to measure adherence and related outcomes.

Researchers are collecting data on patients with Epidermal Growth Factor Receptor EGFR-mutant Non-Small Cell Lung Cancer NSCLC who are treated outside of a clinical trial with standard care using osimertinib alone or combined with chemotherapy. The goal is to better understand the safety and effectiveness of these treatments as they are used in routine clinical practice. This is an observational study recruiting about 250 patients per treatment group, including those receiving osimertinib alone or osimertinib plus chemotherapy. Patients are treated according to standard medical care as determined by their doctors. One group receives osimertinib by mouth once daily, while the other group receives osimertinib plus chemotherapy, with chemotherapy type chosen by the treating physician. Treatment dosing and administration follow standard guidelines. The study records planned treatments at registration and observes outcomes without altering the care given. Participants will have clinical and imaging assessments as part of their usual care, with data collected on their health and treatment progress. Researchers will measure real-world progression-free survival, overall survival, and time to stopping osimertinib for up to three years. The study follows participants over time to monitor how they respond to therapy and to gather safety information.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.