Boehringer Ingelheim to advance Survodutide into 3 global Phase III studies in obesity
Germany: Boehringer Ingelheim has announced it will advance survodutide, its glucagon/GLP-1 receptor dual agonist, into three registrational Phase III studies for people living with overweight or obesity. This decision was based on recently presented data from a Phase II dose finding study in people living with overweight or obesity. The study demonstrated up to 19 percent weight loss after 46 weeks of treatment with survodutide.
“With a strong heritage in cardio-renal-metabolic disease, we are continuing to expand and accelerate our portfolio in this area with the aim of bringing survodutide to patients in need as quickly as possible,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “There is a significant unmet medical need for effective treatments for obesity. With its dual mode of action, survodutide has the potential to further improve outcomes for people living with the disease and its associated complications.”
Insights from previous studies will now be applied to the design of three global Phase III studies, which will investigate the efficacy and safety of survodutide. Details of the studies will be disclosed prior to their initiation and enrollment of patients is planned before the end of 2023.
In 2016, more than 1.9 billion adults were overweight - defined as a body mass index (BMI) of 25 or more, of which over 650 million were living with obesity - defined as a BMI of 30 or more. The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with overweight or obesity, making it a global health challenge and placing a high burden on individuals, healthcare systems, and society. Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that presents a risk to a person’s overall health.
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the GLP-1 and glucagon receptors, which are critical to controlling metabolic functions. It is also evaluated in a Phase II study in adults with NASH and liver fibrosis (stages F1/F2/F3) with and without type 2 diabetes for which it received US FDA Fast Track Designation. Co-invented by Boehringer Ingelheim and Zealand Pharma, survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardio-renal-metabolic disease areas.
