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Researchers are evaluating whether zongertinib, an oral medication targeting HER2 mutations, can improve outcomes compared to standard adjuvant treatments in adults with completely removed Stage II to IIIB non-small cell lung cancer (NSCLC) with activating HER2 tyrosine kinase domain mutations. Participants must have had surgery intended to cure the cancer and received standard systemic therapy around the time of surgery, including neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. This global, open-label Phase 3 study aims to assess if zongertinib can extend the time participants remain free from disease. After surgery and necessary systemic therapy, participants are randomly assigned to one of two groups. One group receives zongertinib orally once daily for up to three years. The other group receives standard care, which may include approved adjuvant immunotherapy drugs such as pembrolizumab, atezolizumab, durvalumab, or nivolumab, or observation depending on local medical practices and patient status. This comparison allows researchers to evaluate zongertinib against current treatment standards. Participants will be monitored regularly to assess disease-free survival over a period of up to eight years and five months. Researchers also evaluate overall survival, safety, tolerability, and patient-reported outcomes throughout the study. Tumor samples are collected to confirm HER2 mutation status, and participants' health and organ function are regularly assessed to ensure safety during the trial.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.

Researchers are conducting an observational study to create a registry of Brazilian patients with hereditary cardiovascular diseases by combining clinical data with genomic information. The study aims to identify which genes are most commonly affected and determine the frequency of these genetic changes in the population. Participants have hereditary cardiovascular conditions such as various types of cardiomyopathy, familial hypercholesterolemia, Marfan syndrome, and other related syndromes. Participants undergo whole genome sequencing using DNA collected from a buccal swab to analyze their genetic makeup. This sequencing serves as a diagnostic test to explore genetic diversity and variant frequency related to their conditions. The genetic information is collected as part of routine medical care visits at multiple centers within Brazil's Unified Health System. During the study, participants will be interviewed and provide clinical information for the registry. Researchers will measure outcomes including diagnostic yield, genetic diversity, and variant frequency 30 months after the study start. Participants must consent to genetic counseling and provide informed consent. The study focuses on collecting detailed clinical and genomic data to better understand hereditary cardiovascular diseases in Brazil.

Researchers are evaluating the effects of a polypill combined with colchicine for reducing cardiovascular risk in patients with established atherosclerotic cardiovascular disease. This large, multicenter, randomized clinical trial includes over 7,700 participants aged 45 and older. The study aims to provide evidence on these treatments in a diverse population, especially in Brazil, where cardiovascular disease rates and risk factors remain high and often poorly controlled. Participants are assigned to receive either a fixed-dose cardiovascular polypill containing valsartan, atorvastatin, and aspirin in various dose combinations, colchicine 0.5 mg once daily, matching placebo, or usual care according to standard guidelines. The polypill is designed as a single daily dose to improve adherence. Some polypill formulations are reserved for cases of statin-related muscle symptoms. The trial employs a 2x2 factorial design to assess the benefits of the polypill and colchicine both separately and combined. During the estimated 3-year study period, researchers will monitor major adverse cardiovascular and limb events as the primary outcome. Participants will undergo evaluations including medical assessments and safety monitoring. The study will assess rates of cardiovascular events, treatment adherence, and safety to help determine if these combined therapies can better prevent complications in people with atherosclerotic cardiovascular disease.

Researchers are evaluating whether intravenous Tenecteplase (TNK) is better than placebo for patients who have a non-large vessel occlusion ischemic stroke occurring between 4.5 and 12 hours from when they were last seen well. This phase III, multi-center, randomized, double-blind trial focuses on patients showing a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging, aiming to improve functional outcomes measured at 90 days after treatment. Participants will be randomly assigned in a 1:1 ratio to receive either intravenous TNK at a dose of 0.25 mg/kg (maximum 25 mg) given as a bolus over 5 seconds, or a matching placebo. Randomization accounts for age, stroke severity, therapeutic window, and clinical site. The trial plans to enroll a total of 466 participants, with interim analyses to monitor efficacy and safety. During the study, participants will be followed for 90 days after randomization. Researchers will assess functional outcomes using the modified Rankin Scale adjusted for baseline stroke severity and neurological status. Imaging such as CT or MRI scans and clinical evaluations will be used to confirm eligibility and monitor progress. Safety and efficacy data will be collected throughout the study period.