Boehringer Ingelheim and Zealand Pharma A/S announced the initiation of three Phase III trials investigating survodutide (also known as BI 456906) for people living with overweight or obesity. The trial design builds upon learnings from Phase II, in which people living with overweight or obesity achieved up to 19% weight loss. The Phase III trials will soon open for recruitment.

Additional Phase II data, presented at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD), demonstrated reductions in absolute waist circumference (up to 16.0 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. SYNCHRONIZE-1 (NCT06066515) and SYNCHRONIZE-2 (NCT06066528), now listed on, are Phase III studies investigating survodutide in people with obesity (BMI =30 kg/m2) or overweight (BMI =27 kg/m2) with comorbidities, including dyslipidemia, hypertension and obstructive sleep apnea. SYNCHRONIZE-1 will enrol people without type 2 diabetes (A1C <6.5%) and SYNCHRONIZE-2 will enrol people with type 2 diabetes (A1C =6.5%, <10%).

For both studies, the primary endpoints are percent change in body weight at week 76 and the proportion of people who achieve body weight loss of 5% or more at week 76. Secondary endpoints include body weight reductions of at least 10%, 15% and 20% at week 76. A total of 600 participants will be enroled in each of the two studies, randomized to receive weekly subcutaneous injections of either survodutide, reaching a maximum dose of 3.6 mg or 6.0 mg for maintenance treatment, or placebo.

The third study, SYNCHRONIZE-CVOT, is a Phase III trial that will enrol people with overweight or obesity with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease. In SYNCHRONIZE-CVOT, the primary endpoint is the time to first occurrence of any one of five major adverse cardiac events (5P-MACE): death, non-fatal stroke, non-fatal myocardial infarction, ischemia-related coronary revascularization and heart failure events.