Latina

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

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.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

Researchers are studying women who carry mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 to better understand their risk of developing cancer. This observational study aims to collect national data from women with these mutations, as current management strategies are not fully established. The study focuses on the Italian population, where an estimated 140,000 to 150,000 women carry these mutations, and many face a high lifetime risk of genetically linked tumors. Participants will be registered on a platform where their clinical data related to BRCA1 or BRCA2 mutations will be collected. The study does not involve treatment but gathers detailed information about mutation distribution, access to genetic evaluation, lifestyle risk factors, preventive strategies, and surgical risk reduction approaches such as salpingo-oophorectomy. Women in the study will provide data that researchers will analyze to understand mutation geography, related cancer types, and screening criteria. Data collection occurs over different time frames, including immediate and six-month intervals. The study continues through long-term observation to monitor outcomes and preventive efforts, with no active intervention applied to participants.

Researchers are investigating the order in which early symptoms, called premonitory symptoms, appear before migraine headaches. These symptoms mark the start of a migraine attack and involve changes in brain activity. However, the exact sequence of these symptoms and brain changes remains unclear, and this study aims to fill that gap by tracking these symptoms across multiple migraine episodes. Participants will use a special electronic diary to record the type, order, start time, and duration of premonitory symptoms during up to five migraine attacks. They will be asked to make these entries as soon as possible at headache onset, with timestamps to reduce memory errors. Data collection uses a structured diary on the REDCap platform and a standardized case report form. During the study, participants will track their symptoms across several migraine attacks over up to six months. Researchers will assess how often each symptom appears first, the timing between symptoms and headache, and the consistency of symptoms across attacks. They will also compare reported symptoms with diary data, evaluate symptom impact on disability, and monitor symptom evolution during headache phases.

Researchers are conducting a phase III randomized clinical trial to study early stage Follicular Lymphoma, a type of lymphoma that has not been treated before. The trial compares the effects of local Radiotherapy alone versus Radiotherapy combined with the drug Obinutuzumab. The goal is to better understand how these treatments work for patients with early stage Follicular Lymphoma and to evaluate progression-free survival and other outcomes. Participants will be randomly assigned to one of two groups one group will receive involved-site Radiotherapy at a standard dose of 24Gy alone the other group will receive the same Radiotherapy followed by Obinutuzumab infusionsfour weekly doses plus four additional doses every three weeks, totaling eight doses. This open-label study is conducted across multiple centers. During the study, participants will be monitored for treatment response and side effects over a period of up to 45 months, including 9 months of treatment and 36 months of follow-up. Assessments include imaging scans, laboratory tests, and molecular analyses to evaluate response rates, disease progression, and molecular markers. Safety and adverse events will be tracked throughout, with long-term follow-up to understand treatment effects and disease status.

This research aims to evaluate the efficacy and safety of rimegepant compared to a placebo as a preventive treatment for migraine in children and adolescents aged 6 to under 18 years with episodic migraine. It focuses on reducing the frequency of migraine days over a 12-week period, particularly in young patients who experience mild to moderate disruption in daily activities due to migraine. The study is designed as a Phase 3 randomized, double-blind trial to assess this preventive approach. Participants will be randomly assigned to receive either rimegepant at doses of 75mg or 50mg two 25mg orally disintegrating tablets or a matching placebo with the same dosing options. The treatment phase lasts 12 weeks in a double-blind manner, followed by a safety and tolerability evaluation over a total of 72 weeks. The study includes sequential treatment with careful monitoring of migraine frequency and medication use during this period. Throughout the trial, participants will be monitored for migraine days per month, reduction in migraine frequency, and quality of life as measured by the Pediatric Quality of Life Inventory PedsQL. Researchers will also assess the use of acute migraine medications, hepatic-related adverse events, and overall safety. The primary outcome focuses on the change in migraine days during the 12-week treatment phase. Participants adherence and safety will be tracked throughout the treatment and follow-up periods, lasting up to nearly 10 years until study completion.

The trial investigates treatment options for adults aged 18 to 70 with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS, focusing on the feasibility of allogeneic stem cell transplantation HSCT. It compares upfront HSCT with pre-treatment using azacitidine or conventional chemotherapy based on the patients bone marrow blast counts. This phase III, open-label, randomized multicenter study aims to determine whether pre-transplant treatments affect the ability to proceed with HSCT. Participants are assigned to groups depending on their bone marrow blast levels. Those with 10% or more blasts receive either conventional chemotherapy following a 37 protocol or azacitidine given subcutaneously at 75 mgm2 daily for 7 days every 28 days for at least 4 cycles before HSCT if a suitable donor is available. Patients with less than 10% blasts may receive upfront HSCT or azacitidine prior to HSCT under similar dosing schedules. The study evaluates these different sequences of therapy to assess HSCT feasibility. During the study, participants undergo regular assessments over four years to monitor whether they proceed to HSCT. Researchers track treatment outcomes, safety, and overall feasibility by measuring the proportion of randomized patients who receive the transplantation. The trial includes follow-up for at least four years to collect data on these outcomes and ensure participant safety and treatment adherence throughout the process.

Researchers are evaluating the effect of adding gemtuzumab ozogamicin to standard chemotherapy for adults aged 18 to 60 with newly diagnosed favorable or intermediate-risk acute myeloid leukemia AML. This phase 3 study aims to reduce minimal residual disease MRD levels before transplantation and assess whether MRD-driven post-remission therapy can improve anti-leukemic outcomes. The study excludes patients with certain genetic markers or prior treatments to focus on a specific AML subgroup. Participants receive induction treatment with gemtuzumab, daunorubicin, and cytosine arabinoside, followed by consolidation therapy with adjusted doses of these drugs. After consolidation, patients undergo either autologous or allogeneic stem cell transplantation based on their MRD level. This MRD-guided approach helps tailor the intensity of post-remission therapy. Throughout the study, participants undergo MRD assessments to measure treatment activity, with the primary outcome being MRD negativity two months after starting therapy. Researchers also monitor kidney and liver function, heart health, and overall compliance with study procedures. The study involves regular clinical observations and assessments to evaluate the effectiveness of the combined treatment and its impact on MRD levels over time.