Nuneaton

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

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 LY3457263 compared with a placebo in adults with type 2 diabetes who have not reached their hemoglobin A1c HbA1c goal despite being on stable doses of semaglutide or tirzepatide. This Phase 2, double-blind study focuses on measuring changes in HbA1c levels. Participation in the trial lasts about nine months, aiming to provide insights into treatment effects in this specific patient group. Participants will be randomly assigned to receive one of three doses of LY3457263 or a placebo, all given by subcutaneous injection once weekly. The study uses a parallel-group design where each participant receives only one assigned treatment. The trial compares these treatments over a 24-week period to assess their impact on blood sugar control and body weight. During the study, participants will undergo regular assessments including blood tests to measure HbA1c and fasting serum glucose, as well as body weight measurements. These evaluations occur at baseline and at 24 weeks. The study team will monitor participants health and treatment effects throughout the trial, which is expected to last about nine months in total.

Researchers are evaluating the efficacy, safety, and tolerability of IMVT-1402 in adults with Graves disease who remain hyperthyroid despite treatment with antithyroid drugs ATD. The study is a randomized, double-blind, placebo-controlled Phase 2b trial aiming to compare IMVT-1402 against placebo by measuring thyroid hormone levels and ATD dose changes at Week 26. Participants receive either IMVT-1402 or placebo via subcutaneous injections once weekly. Some groups will receive IMVT-1402 for 52 weeks, others IMVT-1402 for 26 weeks followed by placebo for 26 weeks, and one group will receive placebo for 52 weeks. The study evaluates thyroid hormone levels, seronegative status for thyroid receptor antibodies, and sustained euthyroidism at multiple time points up to Week 104. During the trial, participants undergo regular assessments of thyroid hormones T3, FT3, FT4, TSH, antibody levels, and clinical status. Researchers will monitor participants up to two years to assess the proportion achieving normal thyroid function without ATD and maintaining this status over time. Safety and tolerability of IMVT-1402 are also evaluated throughout the study.

Researchers are studying VX-993 to evaluate its effectiveness, safety, and tolerability in adults with pain caused by Diabetic Peripheral Neuropathy DPN, a condition linked to diabetes that affects nerve function in the lower limbs. This Phase 2 trial compares VX-993 with Pregabalin, an existing medication used to manage this type of pain, to better understand how these treatments work for participants with DPN. Participants are randomly assigned to receive either varying doses of oral VX-993 tablets or Pregabalin capsules. The study is double-blind and includes matched placebos for both treatments to maintain unbiased results. The trial lasts up to 16 weeks, with primary evaluations focused at 12 weeks to measure changes in pain intensity using a numeric scale. During the trial, participants will undergo regular assessments of their daily pain levels and monitoring for any adverse effects. Researchers will track the percentage of pain reduction and evaluate safety through reports of side effects. The study spans from initial screening through treatment and follow-up, with ongoing safety assessments to support participant well-being throughout the process.

Researchers are evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating whether adding diffusion weighted MRI scans of the liver at diagnosis can detect more synchronous metastases than CT scans alone in patients with high risk colorectal cancer. This phase II multicenter study focuses on patients with advanced primary colorectal tumors who have no evidence of liver metastases on CT. The liver metastases found through the additional DW-MRI scans will be reviewed by a multidisciplinary team to determine appropriate management based on local protocols. Participants will undergo additional liver DW-MRI scans including T2-weighted, diffusion weighted imaging, and apparent diffusion coefficient sequences. These scans will be performed six months after surgery and then every six months for three years to monitor for liver metastases. If liver metastases are detected, treatment decisions will be made by the local multidisciplinary team following their standard procedures. During the study, participants will have regular imaging assessments to track the presence and progression of liver metastases. Researchers will analyze baseline tumor risk factors, patterns of metastatic relapse, and survival outcomes over time. The primary outcome is the detection and treatment of liver metastases as guided by local protocols, with follow-up to five years after the last patient is recruited. This study aims to improve understanding of liver disease progression in high risk colorectal cancer and assess the accuracy of DW-MRI as a screening tool.

Aortic stenosis AS affects many older adults, with a rising number of people over 65 and 75 years old experiencing moderate to severe disease. This study aims to compare the benefits of early aortic valve replacement AVR versus expectant management in patients with severe asymptomatic AS. It addresses a significant gap, as no randomized controlled trials have yet compared these approaches to determine which leads to better outcomes and cost-effectiveness. Participants will be randomly assigned to either early AVR, where surgery or transcatheter AVR TAVI is planned within six months, or to expectant management, involving regular monitoring according to standard hospital practice. The study will be conducted across multiple centers in the UK, Australia, and New Zealand, with an internal pilot phase to confirm recruitment feasibility. Those in the AVR group may undergo additional tests such as coronary angiography, with further treatment decisions made by their care team. During the study, participants will be followed for a median of 5.5 years, with assessments including cardiovascular events, hospitalizations, quality of life questionnaires, and health economics evaluations. Researchers will measure a combined outcome of cardiovascular death, heart failure hospitalization, and stroke, along with other health and disability measures. The study will use intention-to-treat analysis, ensuring participants are evaluated in their assigned groups regardless of treatment received.