Richmond

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 effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of obexelimab in adults with systemic lupus erythematosus (SLE). Participants must have had an SLE diagnosis for at least 24 weeks and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria. Eligible patients must have active SLE with specific disease activity scores and be receiving certain standard lupus treatments such as oral corticosteroids, antimalarials, or immunosuppressants. The study includes a 24-week treatment period where participants are randomly assigned to receive either obexelimab or a placebo through weekly subcutaneous injections. Before treatment, there is a screening period lasting up to 28 days, and after the treatment phase, participants enter a 12-week follow-up period. Visits to the study site occur at weeks 2, 4, and then every 4 weeks throughout the study. During the study, participants will undergo regular assessments to monitor treatment effectiveness, safety, drug levels, immune response, and overall health. The maximum time a participant can be involved in the study, including screening and follow-up, is about 40 weeks. Researchers will collect data to evaluate how well obexelimab works and its safety profile in managing SLE symptoms.

Researchers are evaluating the safety and effectiveness of trontinemab in people with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's. This Phase III study is designed to better understand how trontinemab affects cognitive decline in this population. Participants have confirmed Alzheimer's disease pathology and meet specific clinical criteria related to memory and cognitive function. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. Treatment will be given over a defined period, and participants will be monitored closely throughout. During the study, participants will undergo various assessments including MRI scans, clinical genotyping, and PET imaging or cerebrospinal fluid tests to confirm disease status. Cognitive tests such as the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating are used to track changes. Researchers will measure the change in Clinical Dementia Rating Sum of Boxes from baseline to week 72 to evaluate treatment effects. Safety and tolerability will also be monitored throughout the study duration.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are evaluating the effects of inhaled epinephrine in people aged 12 and older who experience systemic allergic reactions during allergy testing, subcutaneous immunotherapy (SCIT), oral challenges with food or drugs, or oral immunotherapy (OIT). This Phase 1b, multi-center, open-label exploratory study focuses on individuals who may not qualify for the GHL-101 trial. The study aims to better understand how inhaled epinephrine impacts these allergic reactions, which can be serious and require careful management. Participants will receive inhaled epinephrine with a dose of 0.125 mg per inhalation, up to a maximum of 1.0 mg, delivered as eight inhalations over six minutes. The study will involve up to 100 patients who have experienced moderate to severe systemic allergic reactions (Grade 2 or higher) following allergy testing, SCIT, or oral challenges. The study is designed to observe the effects of this treatment in a controlled setting over a short period. Each participant's total involvement will last about one week. During this time, researchers will measure the time it takes for systemic symptoms to resolve after the first dose of inhaled epinephrine. Monitoring will include observing symptoms for up to 60 minutes following administration. The study will also assess the complete resolution of systemic symptoms to evaluate the treatment's impact. Safety and eligibility will be carefully monitored throughout the study period.

This research aims to observe how comfortable and well-fitting the Invisalign4 System with mandibular advancement featuring occlusal blocks is for participants. It focuses on people aged 10 to 16 who have conditions like Class II malocclusion, mandibular retrognathism, mandibular advancement, or excessive overjet. The study seeks to evaluate how the occlusal blocks engage while using this dental device. Participants will use the Invisalign4 System with mandibular advancement featuring occlusal blocks, a device designed to correct Class II dental issues by advancing the lower jaw. The study monitors the fit and comfort of these aligners as participants wear them. This is a post-market study, meaning it evaluates the device after it has been made available for use. During the study, which can last up to 2 years, researchers will assess participants' comfort and how well the aligners fit using the device. These evaluations help understand the experience of using the Invisalign4 System with mandibular advancement over time. The study involves ongoing monitoring to gather this information throughout the participation period.