SYNCHRONIZE-1, SYCHRONIZE-2, SYNCHRONIZE-CVOT will evaluate survodutide for overweight and obesity.
Boehringer Ingelheim and Zealand Pharma A/S have announced the initiation of 3 phase 3 trials investigating survodutide (BI 456906) for those living with overweight or obesity. Recruitment will open for the trials soon, according to a statement from Boehringer Ingelheim.
Survodutide is a glucagon/glucagon-like peptide (GLP)-1 receptor dual agonist that activates both receptors that are crucial to metabolic functions.
“As the prevalence of the disease of obesity continues to increase, it is imperative that we develop additional innovative approaches to address this serious, chronic disease,” Carel le Roux, MD, PhD, a professor at University College in Dublin, Ireland, said in the statement. “Survodutide has a novel mechanism of action with the potential to reduce appetite while increasing liver energy expenditure. The promising phase 2 data give us reason to be hopeful about the potential of survodutide as a treatment for [individuals] living with the disease of obesity.”
The announcement follows phase 2 trial results that demonstrated the patient population achieved up to 19% weight loss with survodutide. Additionally, the data showed reductions in absolute waist circumference, up to 16 cm, absolute body weight, up to 19.5 kg, and absolute systolic and diastolic blood pressure, up to 8.6 mmHg and 4.8 mmHg, respectively, over 46 weeks. The results were presented at the 59th Annual Meeting of the European Associations for the Study of Diabetes.
SYNCHRONIZE-1 (NCT06066515) and SYCHRONIZE-2 (NCT06066528) will investigate the drug in those with obesity, defined as a body mass index (BMI) of 30 kg/m2 or more, or overweight, defined as BMI of 27 kg/m2 or greater, with comorbidities that include dyslipidemia, hypertension, and obstructive sleep apnea, according to the statement. In SYNCHRONIZE-1, individuals without type 2 diabetes (T2D) will be enrolled while SYNCHRONIZE-2 will enroll those with T2D.
In both studies, the primary endpoint will include the percent change in body weight and the proportion of individuals who achieve a body weight loss of 5% or more at 76 weeks. Secondary endpoints will also include body weight reduction of at least 10%, 15%, and 20% at week 76.
Furthermore, 600 individuals will be enrolled and randomized in each study receive a weekly subcutaneous injection of either survodutide, with a maximum dose of 3.6 mg or 6 mg for the maintenance of treatment, or the placebo, according to the statement.
The third study, SYNCHRONIZE-CVOT, is not yet on clinicaltrial.gov. It will be a phase 3 trial that enrolls individuals with overweight or obesity and who have cardiovascular disease (CVD), chronic kidney disease, or risk factors for CVD. The primary endpoint included time to first occurrence of any 1 of 5 major adverse cardiac events: death, non-fatal stroke, non-fatal myocardial infarction, ischemia-related coronary revascularization, and heart failure events.
“By implementing the valuable insights gained from the phase 2 study, we are confident in the accelerated development of survodutide,” Carinne Brouillon, PharmD, head of Human Pharma at Boehringer Ingelheim, said in the statement. “Obesity is a chronic disease associated with serious health complications that affects hundreds of millions worldwide. With these trial initiations, we continue to build on our heritage of bringing differentiated and innovative treatments to address cardiovascular, renal, and metabolic diseases.”
Phase 3 studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease, and chronic kidney disease. News release. Boehringer Ingelheim. October 5, 2023. Accessed October 5, 2023. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/obesity/phase-3-studies-survodutide-obesity-and-overweight