Vestavia Hills

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.

Researchers are evaluating the safety, tolerability, and activity of inhaled GDC-6988 in adults with muco-obstructive diseases, including Non-cystic Fibrosis Bronchiectasis and Chronic Obstructive Pulmonary Disease. This Phase 1c, open-label, multicenter study aims to understand how the treatment affects lung function and adverse events in these participants. The study involves administering GDC-6988 using a dry powder inhalation device. Participants must be on stable treatment for their condition and demonstrate proper use of the inhaler. The study includes different cohorts with specific criteria based on disease type and severity, such as chronic sputum production and lung function measures. Some participants will provide sputum and blood samples for exploratory biomarker research. Participants will be monitored for adverse events and lung function abnormalities using spirometry over a period of up to 6 weeks. Safety will be assessed using the Division of Acquired Immunodeficiency Syndrome Toxicity Grading Scale. The study also evaluates lung function changes and collects biomarker data to understand treatment effects. The total duration and follow-up details are aligned with these assessments to ensure participant safety and data collection completeness.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the effectiveness and safety of ZILRETTA, a medication given as a single injection into the shoulder joint, in adults aged 50 to 80 years with glenohumeral osteoarthritis (OA). This Phase 3, multi-center, randomized, double-blind study compares ZILRETTA to a placebo (normal saline) to see its impact on shoulder pain. The study aims to measure pain relief at 12 weeks and assess safety over 24 weeks. Participants will receive one injection of either 32 mg ZILRETTA or placebo into the affected shoulder joint. After the injection, they will be followed for 24 weeks, with eight outpatient visits scheduled at 2, 4, 8, 12, 16, 20, and 24 weeks. The study includes a screening period lasting from 10 to 35 days before treatment. During the study, participants will complete pain and sleep interference questionnaires daily using an electronic diary. Throughout the study, participants will undergo physical exams, shoulder assessments, and X-rays. Blood samples will be taken to monitor safety, and vital signs will be checked regularly. Researchers will collect information on any side effects, use of other medications, and rescue pain medicine. The main outcome is the change in worst daily pain score at 12 weeks, with ongoing safety monitoring through the 24-week study period.