Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings for regulatory Phase III global multi-center studies in China for its novel glucagon receptor/GLP-1 receptor dual agonist, survodutide. The drug is co-developed with Zealand Pharma, marking a significant step in advancing the drug’s clinical development.
Positive Results from Phase II Studies
Boehringer Ingelheim previously released data from a dose-exploration Phase II study involving overweight or obese individuals. The study demonstrated that after a 46-week period of survodutide treatment, patients experienced up to a 19% weight reduction, with participants from China included in the trial. These results highlight the potential efficacy of survodutide in weight management.
Therapeutic Effects in NASH and Liver Fibrosis
Another Phase II study evaluated the therapeutic effect of survodutide in adult patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis (F1/F2/F3), regardless of whether they have type 2 diabetes. This indication was awarded fast-track status by the US Food and Drug Administration (FDA), underscoring the drug’s potential to address a significant unmet medical need.-Fineline Info & Tech
