Antequera

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

Researchers are evaluating whether a comprehensive nurse-led program called BEST CARE ICTUSHC can reduce complications and improve recovery for adults aged 18 and older hospitalized with acute ischemic or hemorrhagic stroke in hospitals lacking specialized Stroke Units. The study aims to see if this program improves early detection of swallowing difficulties to prevent pneumonia and reduces attention problems like hemineglect, enhancing quality of life up to six months after discharge. This trial compares patients receiving the BEST CARE ICTUSHC program with those receiving usual hospital care in a stepped-wedge design across multiple hospitals. The BEST CARE ICTUSHC intervention includes specialized training for nursing staff, systematic use of the Modified Swallowing Assessment to detect dysphagia, and the FLECHA Project, which adapts the patients environment with visual signs, spatial reorganization, and QR code-guided care plans tailored to stroke type and side. It also involves strict monitoring protocols for temperature, blood sugar, and blood pressure, plus early removal of invasive devices. During the control phase, usual care is provided without standardized dysphagia screening. The intervention phase adds educational outreach, compensatory care strategies, and ongoing support to ensure program implementation. Participants will be monitored from admission through hospitalization, discharge, and follow-up at 30 days and six months post-discharge. Assessments include swallowing tests, evaluation of hemineglect using the Catherine Bergego Scale, and health-related quality of life measurements. Vital signs and device use are tracked daily during hospital stay. Follow-up calls collect health and quality of life data. The study uses statistical methods to account for hospital differences and time effects, aiming to understand both clinical outcomes and how the program integrates into routine care.

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.