Antrim

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.

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

Researchers are evaluating the use of EEG-based Brain-Computer Interface BCI technology to detect awareness and enable communication in people with prolonged disorders of consciousness DoC, such as unresponsive wakefulness syndrome UWS, minimally conscious state MCS, and locked-in syndrome LIS. The study aims to improve diagnosis accuracy where traditional methods relying on motor responses may fail, and to explore if BCI can provide movement-independent communication. The trial also investigates whether training with BCI can enhance brain response consistency and communication ability. Participants undergo three phases Phase I assesses if patients can imagine movements and produce detectable brain activity using EEG. Phase II involves training with motor imagery BCI and real-time auditory feedback to help participants modulate brain signals. Phase III tests participants ability to answer yes-no questions using imagined movement patterns. The study uses specific imagined movement combinations to represent yes or no responses, tailored individually and applied throughout sessions lasting about 1.5 hours each. During the study, participants complete up to 10 sessions including assessments, training, and communication tasks. Researchers monitor changes in BCI performance accuracy, ability to communicate consistently, and clinical scale scores related to consciousness and recovery. The study evaluates how feedback types and timing affect performance and collects data to support clinical diagnosis and potential therapeutic benefits. Participation involves EEG recordings, neurofeedback, and answering structured questions over several weeks.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating whether metformin, a medication commonly used for diabetes, can be repurposed to slow kidney function decline in adults diagnosed with early-stage Autosomal Dominant Polycystic Kidney Disease ADPKD. ADPKD causes cyst growth in kidneys leading to pain, high blood pressure, chronic kidney disease, and reduced quality of life. This global Phase III randomized controlled trial aims to find effective, affordable treatments to reduce illness impact and improve life quality for ADPKD patients. Participants are randomly assigned to receive either extended-release metformin Metformin XR or a placebo, alongside standard care, for 104 weeks. The metformin dose ranges from 500 to 2000 mg daily based on individual tolerance and kidney function. The study includes a control group receiving identical placebo tablets for comparison. This design allows assessment of metformins effect on slowing disease progression. During the study, participants undergo regular monitoring including kidney function tests, assessment of kidney disease progression, quality of life questionnaires, and tracking of side effects and healthcare use over 24 months. The primary outcome is the change in estimated glomerular filtration rate eGFR. Secondary outcomes include kidney failure, mortality, medication dosing changes, and symptoms related to ADPKD. Safety and effectiveness are carefully followed throughout the trial period, which may last until 2030.

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.

Idiopathic pulmonary fibrosis IPF is a progressive lung disease causing scarring that leads to coughing and breathlessness. Many IPF patients also have reflux disease, where stomach acid can damage the lungs. This research aims to find out if treating IPF patients with proton pump inhibitors PPIs, which reduce stomach acid, can slow down the progression of IPF. The trial is a randomized, placebo-controlled study involving 298 IPF patients across about 37 UK hospitals. Participants will be randomly assigned to take either lansoprazole a PPI or dummy tablets twice daily for 12 months. They will start weekly breathing tests at home using equipment provided and, if they have a cough, use a device to count coughs over 24 hours. Participants will complete questionnaires about coughing, breathlessness, sleep habits, and overall health. Some will also wear activity and sleep monitors during cough monitoring sessions. Dose reduction is allowed if side effects occur. During the study, patients will complete regular questionnaires and provide blood samples for safety checks at 3, 6, 9, and 12 months. Weekly home spirometry will continue for the full year. Researchers will track lung function, cough frequency and severity, breathlessness, quality of life, sleep quality, reflux symptoms, and hospital-free survival. Remote and in-person visits are possible, and participants will receive training on study procedures. The primary outcome is the change in lung function 12 months after starting treatment.