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The phase 3 study will advance the safety findings of survodutide reported in the phase 2 study to aid overweight and obesity.
Boehringer Ingelheimannounced it will advance survodutide — a glucagon-like peptide (GLP)-1 receptor dual agonist that activates the GLP-1 and glucagon receptors, which are crucial parts to controlling metabolic functions. The researchers are advancing this receptor dual agonist into a registrational phase 3 study for individuals with overweight or obesity.
In 2016, more than 1.9 billion adults were overweight, with a body mass index (BMI) of 25 or more. Additionally, 650 million adults were reported to be living with obesity, with a BMI of 30 or more. Living with overweight or obesity is a global health issue that presents a risk to an individual’s overall health.
In the previous phase 2 study, survodutide was being evaluated for adults with nonalcoholic steatohepatitis and liver fibrosis who received an assigned dose at random and a dose at the end of treatment. Those who had the 4.8 mg dose at the end of treatment reported achieving 19% weight loss after being on treatment for 46 weeks.
The researchers are using information found in the phase 2 study to design the global phase 3 study, which is intended to investigate the efficacy and safety of survodutide. More details of the study will be provided after the initiation and enrollment of patients at the end of 2023.
“There is a significant unmet medical need for effective treatments for obesity,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “With its dual mode of action, survodutide has the potential to further improve outcomes for people living with the disease and its associated complications.”
Reference:
Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity. Boehringer Ingelheim. News release. August 17, 2023. Accessed August 23, 2023. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/obesity/survodutide-phase-iii-study-weight-loss.