Eastbourne

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 brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are evaluating brenipatide alongside buprenorphine, with or without naloxone, to assess its safety and effectiveness in people with opioid use disorder. This Phase 2 study includes two separate participant groups Part A involves a double-blind treatment phase with a later open-label extension, and Part B features an open-label treatment phase. Participants join only one part of the study. In Part A, participants receive either brenipatide or a placebo by subcutaneous injection plus buprenorphine taken under the tongue or inside the cheek. Part B participants receive open-label brenipatide injections with buprenorphine. The maximum study participation duration is about 144 weeks for Part A and 116 weeks for Part B, depending on enrollment timing and pace. Treatments are given as subcutaneous injections and transmucosal buprenorphine. Participants will attend regular study visits to monitor opioid use through urine drug screens and self-reports, track adherence to buprenorphine, and assess cravings and quality of life. Other measurements include changes in body weight, blood pressure, and healthcare visits. Safety is monitored throughout, and the main outcome focuses on weeks of abstinence from opioid use between weeks 13 and 24. Total participation time varies with study part and enrollment timing.

Researchers are evaluating the clinical and health-related outcomes of amivantamab-containing treatment regimens for patients with common EGFR-mutated advanced non-small cell lung cancer NSCLC, including metastatic cases where the cancer has spread. This study observes these treatments in a real-world setting, focusing on patients with specific EGFR mutations exon 19 deletions or exon 21 L858R substitution. It aims to describe how these regimens perform outside of controlled clinical trials. Participants are grouped into two cohorts one receiving amivantamab combined with carboplatin and pemetrexed after prior therapy failure, and another receiving amivantamab with lazertinib as first-line therapy. Treatments are given according to usual clinical practice, and no study drugs are provided. Data collection captures information from routine care, including treatment administration and related medications. During the study, researchers collect data on treatment duration, progression-free survival, overall survival, adverse events, dose changes, concomitant medication use, and quality of life measures using validated questionnaires. Monitoring continues for up to approximately 60 months. Participants provide informed consent, and all data comes from standard medical records without additional interventions or procedures required by the study.

This trial focuses on people with relapsed or refractory multiple myeloma who have previously received specific treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies. It aims to study preventive treatments to reduce the occurrence, severity, and duration of taste changes caused by talquetamab, and to better understand the symptoms related to both talquetamab and ramantamig therapies. The study is a Phase 2 trial designed to improve management of oral side effects during treatment. Participants receive talquetamab or ramantamig drugs administered subcutaneously. Some groups receive talquetamab alone, while others receive talquetamab combined with different preventive treatments prophylaxes A, B, C, or D starting before talquetamab therapy. Prophylaxes A, B, and C are given orally, while prophylaxis D is applied topically. Treatment continues until disease progression, unacceptable side effects, withdrawal, or end of study, with prophylaxis lasting up to 12 months but possibly longer based on clinical benefit and doctor decision. During the study, participants will undergo various assessments including taste tests and questionnaires about oral symptoms, quality of life, and body measurements. Researchers will monitor the occurrence and severity of taste changes and other oral toxicities over time, dose adjustments, treatment responses, and safety events. This comprehensive monitoring may last up to 36 months, helping to better characterize the side effects and treatment outcomes for multiple myeloma patients receiving these therapies.

Researchers are evaluating the effect of DT-101 compared to placebo in adults with Major Depressive Disorder MDD. This Phase 2 clinical trial aims to assess the safety, tolerability, and impact of DT-101 on depression symptoms in adults aged 18 to 75 years who have recurrent depression diagnosed by DSM 5-TR. The study is randomized, double-blind, and placebo-controlled, focusing on treatment for this condition. Participants will be assigned to one of three groups two experimental groups receiving different formulations of DT-101 DT-101 A or DT-101 B or a placebo group. The study involves regular clinic visits every couple of weeks where the study drug or placebo is administered and ongoing assessments are conducted. Blood and urine samples will be collected to monitor the drugs absorption and use in the body, including optional genetic testing to explore responses to DT-101. During the study, participants will undergo physical and neurological exams, clinical assessments, and complete questionnaires about their health and depression symptoms. The primary outcome measure is the change in depression severity using the Montgomery sberg Depression Rating Scale MADRS over 42 days. Safety and tolerability will be monitored throughout. Participation involves multiple visits for health checks and data collection until the study concludes in August 2027.

Researchers are conducting a randomized phase III clinical trial to evaluate treatments for patients with unilateral malignant pleural mesothelioma MPM. The study aims to compare progression-free survival and overall survival between two groups. It also assesses safety, tolerability, quality of life, and local disease control. Patients are grouped based on tumor histology, treatment center, tumor location, and time since diagnosis. Participants are randomly assigned to one of two groups. The experimental group receives proton beam therapy PBT to the hemithorax 50 Gy in 25 daily fractions over five weeks, with a boost to 60 Gy for visible tumors. The control group follows standard care with active surveillance and no immediate treatment. Both groups are monitored for two years after randomization, with clinic visits every three months in the first year and every four months in the second year. If disease progresses in the control group, patients may receive immunotherapy or chemotherapy based on doctor recommendation. During the study, patients undergo evaluations including scans, pulmonary function tests, and quality of life questionnaires. Researchers track adverse events related to proton therapy and collect data on healthcare resource use and informal care. Follow-up occurs at local centers for two years after treatment start. The main outcomes measured are time to disease progression and overall survival, assessing the potential benefits and risks of proton beam therapy for MPM.

Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.

Researchers are studying patients with chronic lymphocytic leukaemia CLL who have been treated with acalabrutinib in the United Kingdom. This observational study aims to describe the characteristics and real-world clinical outcomes of these patients, especially those who started acalabrutinib treatment as part of the UK Early Access Programme. The study seeks to provide UK-specific data on how patients respond to and tolerate acalabrutinib in typical clinical settings. The study involves reviewing clinical records of treatment-naefve CLL patients who began acalabrutinib between April 1, 2020, and April 1, 2021. The focus is on patients treated in the first-line setting with acalabrutinib under the Early Access Programme. This non-interventional study does not involve new treatments but collects and analyzes existing data to estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. Participants medical information will be gathered from their clinical records following local laws. Researchers will track outcomes such as progression-free survival at various time points up to 60 months, overall survival, response rates, and treatment interruptions. The study design allows for long-term observation of how patients fare with acalabrutinib, providing valuable real-world evidence. The study is expected to continue through April 2027.