Canberra

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 the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are studying an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. The study aims to compare the effects and safety of linvoseltamab combined with standard treatment against the standard treatment alone. This is a Phase 3 randomized, open-label trial sponsored by the European Myeloma Network B.V. Participants will receive either the combination of daratumumab, lenalidomide, dexamethasone, and linvoseltamab or continued treatment with daratumumab, lenalidomide, and dexamethasone alone. Treatments will be given according to the study protocol, and participants will be randomly assigned to one of these two groups. The study will continue for up to 11 years to assess long-term effects. During the study, participants will undergo various assessments including measurements of minimal residual disease MRD, progression-free survival, overall survival, and response rates. Quality of life will also be evaluated using standardized questionnaires. Safety will be closely monitored by tracking adverse events and laboratory tests. Participants will be followed up for up to 11 years, with regular visits to assess disease status and treatment impact.

This trial investigates polyomavirus infections BKPyV in people who have received kidney or simultaneous pancreas-kidney transplants. The study aims to evaluate how reducing or modifying immunosuppression, with or without intravenous immunoglobulin IVIG, affects BKPyV infection, transplant function, graft loss, acute rejection, immunosuppression levels, and survival. BKPyV infection is a serious complication due to the immune system suppression needed after transplantation, which can increase infection risks and damage the transplant. Participants will be randomly assigned to one of two groups one receiving immunosuppression reduction or modification plus IVIG, and the other receiving immunosuppression reduction or modification alone as part of standard care. The immunosuppression adjustments may include dose reductions or switches to less potent medications. IVIG is an antibody treatment with potential antiviral and immune-modulating effects, used here as an additional therapy for BKPyV infection. During the study, participants will be monitored for up to 48 weeks with assessments including viral load, kidney function eGFR, transplant rejection, antibody presence, infection events, hospitalizations, quality of life, cancer diagnosis, and adverse events. The main outcome measured at 11 to 13 weeks combines death, graft loss, kidney function decline, rejection, viral load, and immunosuppression load. Safety and treatment effects will be closely followed throughout the study period.

This research focuses on people aged 55 and older who have or may have clonal haematopoiesis CH, a condition where a group of blood-forming stem cells with specific mutations grows abnormally. CH is common in older adults and can increase the risk of serious health issues like blood cancers, heart disease, and strokes. The study aims to better understand CH detection, outcomes, and patient experiences, helping to guide future care and research in Australia. Participants confirmed or suspected to have CH will be invited to a specialized clinic for molecular testing and monitoring. The study will establish a registry to track their health over time, with regular visits scheduled for assessments. These visits will include blood tests and evaluations to monitor for complications, quality of life, psychological well-being, and disease progression. The study also offers personalized support to participants based on their condition. During the study, participants will provide blood samples and health information at multiple visits over five years, starting with screening and continuing with follow-ups at weeks 6, 52, 104, 156, 208, and 260. Researchers will assess changes in blood cell markers, psychological distress, and participants understanding of CH. The study will create a detailed database to help doctors improve CH care and support future research efforts.

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.

Researchers are investigating new ways to test drug combinations aimed at killing tumor cells in patients with acute myeloid leukemia AML. This observational study focuses on whether using AML cells from individual patients in special mice that can accept human tissue can speed up the discovery of better treatments. It also evaluates if these mice show treatment responses similar to the actual AML patients from whom the cells were taken. Participants in this study are individuals with AML who are receiving the standard treatment of venetoclax and azacitidine. Blood and bone marrow samples will be collected from these patients to create patient-derived xenografts PDX in mice. These mice models mimic the patients disease and treatment response, allowing researchers to test standard and multiple experimental therapies simultaneously over a period of up to two years. The study aims to generate at least 20 adult AML PDX models linked with detailed clinical data. During the study, participants will provide samples before and after starting venetoclax plus azacitidine therapy. Researchers will measure leukemic cell frequency and characteristics using flow cytometry in both the mouse models and patient samples. The main outcomes include the successful creation of AML PDX models and the evaluation of their treatment responses over up to 52 weeks. This approach supports precision therapies tailored to specific tumor profiles and may accelerate future clinical trials of promising drug combinations.