Study Information: SYMPHONY

New Zealand Clinical Research is studying an investigational medicine that could help people with MASH (metabolic dysfunction-associated steatohepatitis) developed by Boehringer Ingelheim Pharma.

This Phase III trial aims to investigate the efficacy and safety of survodutide (BI 456906) once weekly versus placebo on
defined as resolution of steatohepatitis, reduction of liver fibrosis in liver biopsy and long-term improvement in clinical liver
outcomes observed in trial participants with MASH (formerly NASH) and fibrosis stage F2-F3.

A significant unmet need exists among patients with MASH, especially those with comorbid obesity and type 2 Diabetes Mellitus (T2DM), for treatments that simultaneously improve liver health, reduce cardiovascular and renal disease, provide glycemic control, and promote weight loss. The successful development of new therapies for MASH such as survodutide would address a high unmet medical need, particularly given the expected increasing burden of this disease in parallel with the rising global prevalence of obesity and especially T2DM.

Results from the Phase II trial demonstrated histology-proven benefit from survodutide treatment comparing with placebo defined as MASH resolution and fibrosis improvement.

This study (2024 FULL 20853) is being funded by Boehringer Ingelheim Pharma, and has been approved by the Health and Disability Ethics Committee (HDEC).

Study Visits: Fortnightly until week 8, then four-weekly until week 24. Visits are usually in clinic (with some exceptions which can be remote).

Following this a 6-weekly maintenance period commences with until week 52 which includes a biopsy visit. Additional visits and phone call check-ups will be discussed directly with you.