Victoria

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the efficacy and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered via a multidose dry powder inhaler with an electronic module in people aged 12 years and older who have asthma. The study is designed as a randomized, double-blind, placebo-controlled trial and aims to assess lung function improvements, safety, tolerability, and drug behavior in the body over a four-week period. Secondary goals include evaluating the combination inhaler administered four times daily and understanding the pharmacokinetics of the inhaler components after a single dose. Participants will be randomly assigned to one of four groups receiving either the combination inhaler (Fp/ABS), fluticasone propionate inhaler (Fp), albuterol sulfate inhaler (ABS), or a placebo inhaler, all with integrated electronic modules. Treatments are inhalation powders administered via dry powder inhalers. The study lasts about 10 weeks per participant, including the treatment period of four weeks and follow-up assessments. The trial includes a prescreening visit as an option before formal enrollment. During the study, participants will have their lung function measured through forced expiratory volume in one second (FEV1), asthma control assessed by questionnaires (ACQ-6 and ACT), and blood samples taken to analyze drug levels. Safety is monitored by tracking adverse events and tolerability over the treatment period. The main outcomes focus on changes in lung function at baseline and after four weeks of treatment. Participants are expected to attend multiple visits for these assessments throughout the study duration.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the efficacy and safety of tozorakimab, a drug administered under the skin, in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb study is designed as a double-blind, placebo-controlled trial to find the right dose range of tozorakimab for this group. The study aims to better understand how tozorakimab may impact asthma control and reduce severe asthma attacks in this population. Participants will be randomly assigned to one of three groups: one receiving a lower dose of tozorakimab, another receiving a higher dose or placebo, and a third group receiving placebo injections. All treatments are given by subcutaneous injection. The study will last for 26 to 52 weeks, during which the participants will be closely monitored for asthma exacerbations and lung function changes. This includes assessing how well tozorakimab is tolerated and how it affects asthma symptoms and quality of life. During the study, participants will undergo regular assessments including lung function tests, questionnaires about asthma control and quality of life, and blood tests to measure drug levels and immune response. Researchers will track the annual rate of severe asthma flare-ups as the main outcome. Safety will be monitored throughout the study period, and participants will be followed for up to one year. The study is designed to ensure participants receive careful observation and support while contributing valuable information about tozorakimab’s potential use in asthma treatment.

Researchers are studying the effects of dalcetrapib on cardiovascular risk in people who were recently hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, randomized, double-blind, placebo-controlled study aims to understand how this drug may impact the risk of heart-related events in this group. Participants will be screened based on their medical history and genetic testing to confirm eligibility. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily (two 300 mg tablets) or matching placebo tablets once a day. The study will continue until about 200 participants have experienced a primary cardiovascular event or until a planned interim analysis stops the trial. After randomization, follow-up visits will occur every three months, often virtually when possible. During the study, participants will be monitored through medical assessments, including genetic testing, and virtual or clinic visits every three months. Researchers will measure the time to the first fatal or non-fatal heart attack over an average of 30 months from randomization. Secondary measures include death, cardiac arrest, stroke, and heart attacks. If a participant stops taking the study medication early, assessments will continue every three months to collect important study data.

Researchers are evaluating the safety and effectiveness of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraine. This Phase 3 randomized, double-blind study aims to understand how rimegepant may help reduce migraine frequency and improve quality of life in this young population. Participants receive either rimegepant tablets at doses of 75 mg or 50 mg (two 25 mg orally disintegrating tablets) or a matching placebo at the same doses. The study includes a 12-week double-blind treatment phase during which the effects of the medication on migraine days are closely monitored. During the study, participants will track their migraine days and medication use, and complete quality of life assessments such as the Pediatric Quality of Life Inventory. Researchers will evaluate changes in migraine frequency, the use of acute migraine medications, and safety over 72 weeks, including monitoring for liver-related side effects. The primary measurement is the change in average monthly migraine days over the initial 12 weeks of treatment.

Researchers are evaluating the long-term safety and efficacy of plozasiran in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). This open-label Phase 3 extension study includes participants who completed prior related studies and meet specific medical and eligibility criteria, including controlled HbA1c levels. The trial aims to monitor treatment-emergent adverse events and changes in various lipid and cardiovascular markers over 24 months. Participants will receive eight doses of plozasiran, given by subcutaneous injection approximately every three months for two years. Throughout the study, participants are advised to maintain a low-fat diet consistent with local standard care. Additional criteria apply for certain participants transitioning from earlier studies, ensuring proper health status and treatment history. During the study, participants will undergo regular assessments including blood tests to measure triglycerides, cholesterol types, apolipoproteins, and HbA1c. Researchers will also track cardiovascular events, anti-drug antibodies, and any emergent need for apheresis. The trial spans 24 months with continuous monitoring of safety and lipid-related outcomes to understand the long-term effects of plozasiran treatment.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating the effect of abelacimab compared to a placebo on reducing the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients, including those who may have increased bleeding risks and cannot or choose not to take standard blood thinners. Participants will be randomly assigned to receive either abelacimab 150 mg or a matching placebo through a monthly subcutaneous injection. The study is designed as a double-blind, placebo-controlled trial to monitor the safety and efficacy of abelacimab over a period of up to 30 months. During the study, participants will be closely monitored for the time to first occurrence of ischemic stroke, systemic embolism, and bleeding events classified by the Bleeding Academic Research Consortium. Researchers will also track cardiovascular and all-cause mortality, as well as other cardiovascular events. Participants will undergo regular assessments, including electrocardiograms and clinical evaluations, throughout the trial to ensure safety and collect data on treatment effects.