INGELHEIM, Germany & COPENHAGEN, Denmark--(BUSINESS WIRE)--Boehringer Ingelheim and Zealand Pharma A/S (NASDAQ: ZEAL) 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 percent weight loss.1 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.2
“As the prevalence of the disease of obesity continues to increase,3 it is imperative that we develop additional innovative approaches to address this serious, chronic disease,” said Carel le Roux, M.D., Ph.D., Professor at University College in Dublin, Ireland, and Principal Investigator of the trial. “Survodutide has a novel mechanism of action with the potential to reduce appetite while increasing liver energy expenditure.4 The promising Phase II data give us reason to be hopeful about the potential of survodutide as a treatment for people living with the disease of obesity.4”
SYNCHRONIZE-1 (NCT06066515) and SYNCHRONIZE-2 (NCT06066528), now listed on clinicaltrials.gov, 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 enroll people without type 2 diabetes (A1C <6.5%) and SYNCHRONIZE-2 will enroll 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 enrolled 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 enroll 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.
“By implementing the valuable insights gained from the Phase II study, we are confident in the accelerated development of survodutide,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “Obesity is a chronic disease associated with serious health complications that affects hundreds of millions worldwide.5 With these trial initiations, we continue to build on our heritage of bringing differentiated and innovative treatments to address cardiovascular, renal, and metabolic diseases.”
“We are excited that survodutide will shortly enter Phase III trials through the global SYNCHRONIZE program for people living with overweight or obesity,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “With novel peptide therapeutics like survodutide, we are targeting key metabolic pathways, and these therapies have the potential to address one of the most significant healthcare challenges in medicine today.”
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