Edgware

Researchers are evaluating whether a medicine called survodutide can help adults living with obesity who have a liver disease known as non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH combined with moderate or advanced liver fibrosis. This phase III trial aims to find out if survodutide improves liver function and safety over a long period. Participants with other liver diseases or chronic alcohol intake are not eligible. The study has two parts. In the first part, participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of getting survodutide. Both groups inject their assigned treatment under the skin once a week, with doses gradually increasing to a target level. All participants also receive counselling on diet and exercise. The second part focuses on how safe and effective survodutide is over time. Participants stay in the study for up to seven years, with regular visits either in person or through video calls. For about the first year, visits occur every two weeks, then every four weeks, then every six weeks. After the first year, visits alternate between in person and remote every three months. Doctors monitor participants health, body weight, and gastrointestinal effects. Liver health is checked using imaging methods and sometimes liver biopsies. Participants also complete questionnaires about symptoms and quality of life. The study measures whether survodutide helps improve liver disease compared to placebo.

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.