Smithfield

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.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.

Researchers are evaluating the efficacy and safety of two different doses of AZD6793 tablets compared to placebo in adults with moderate to very severe chronic obstructive pulmonary disease (COPD). This Phase IIb randomized, double-blind, placebo-controlled study aims to better understand how AZD6793 affects COPD exacerbations and lung function. Approximately 970 participants will be enrolled across about 350 sites worldwide. Participants will be randomly assigned to one of three groups: one group will receive Dose 1 of AZD6793, another will receive Dose 2, and the third group will receive matching placebo tablets. The study duration is 24 weeks, during which the treatments will be administered orally. The study design includes parallel groups and quadruple blinding to ensure unbiased results. Throughout the 24-week study, participants will undergo regular assessments such as lung function tests measuring forced expiratory volume (FEV1), symptom scales like the Breathlessness, Cough and Sputum Scale (BCSS), COPD Assessment Test (CAT), and St George's Respiratory Questionnaire (SGRQ). Researchers will monitor the rate and timing of moderate or severe COPD exacerbations, collect blood samples to measure AZD6793 levels, and assess safety. This comprehensive monitoring will help evaluate the study drug's impact and participants' health during the trial.

Researchers are studying the safety and immune response of a fifth dose of the Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older who have already received four doses of this vaccine. This Phase 3 trial compares the effects of the vaccine against a placebo (saline) to better understand its protection against Lyme disease. The study is randomized, placebo-controlled, and double-blinded, aiming to assess tolerability and immune response. Participants receive one injection, either VLA15 or saline, into the muscle of the upper arm at their first visit. They are randomized in a 5:1 ratio to either vaccine or placebo. The timing of the fifth dose varies, occurring either one or two years after the fourth dose from a previous study. The trial includes about 1712 participants and uses an independent data monitoring committee to oversee safety. During approximately 12 months of participation, individuals will attend four clinic visits. These visits include health checks, blood draws to measure immune response, and receiving the study injection during the first visit. Researchers will monitor local and systemic reactions within seven days post-injection, adverse events up to one month, and longer-term safety for up to a year. The main outcomes focus on immune responses to different parts of the vaccine and recording any side effects or new medical conditions.

Researchers are studying influenza in children younger than 12 years to understand how the virus changes when treated with the drug baloxavir marboxil. This study has two parts: Part A monitors the presence and development of specific changes in the virus before and after treatment in pediatric patients. Part B focuses on how influenza spreads within households from treated children under 12 to their family members, though no new participants will join Part B as per the latest study update. Participants receive a single oral dose of baloxavir marboxil on the first day, with the dose based on their body weight and age. Household contacts of the treated children are enrolled for observation but do not receive the drug. The study tracks viral changes and resistance at multiple points, including baseline and several days after treatment, and monitors influenza transmission within households. Throughout the study, children will undergo various tests such as local influenza and SARS-CoV-2 testing to confirm infection status. Researchers will measure how often virus mutations associated with resistance occur, changes in viral levels, and any side effects up to 29 days. For household contacts, influenza transmission and symptom development are checked on days 6 and 10. Participation involves scheduled visits and testing to gather this information, with the study expected to continue until mid-2027.

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 adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

This research aims to evaluate the effects of combining baxdrostat 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 elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.

Migraine is a common neurological disorder characterized by moderate to severe throbbing headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of ubrogepant, a drug approved for adults, in treating acute migraine attacks in children and adolescents aged 6 to 17 years. The study includes two participant groups: a pharmacokinetic (PK) cohort and a main study cohort. Children aged 6 to 11 in the PK cohort will receive one of two doses of oral ubrogepant to help determine the appropriate dosing for the main study. In the main study, children aged 6 to 11 will be randomly assigned to receive either a low dose, high dose of ubrogepant, or a placebo, with a one in three chance of placebo assignment. Adolescents aged 12 to 17 will also be randomized to receive low dose, high dose, or placebo. Participants will take oral tablets for qualifying migraine attacks, with the option to take a second dose or rescue medication at least two hours after the first dose if their headache remains moderate or severe. Participants will attend regular hospital or clinic visits over a study period of up to six months. Researchers will monitor treatment effects through medical assessments, blood tests, side effect checks, and questionnaires. The main outcome measured is the percentage of participants who achieve pain freedom two hours after the initial dose. Safety and tolerability will also be assessed throughout the study, including laboratory tests, electrocardiograms, vital sign measurements, and monitoring for suicidal ideation or behavior.