Zealand Pharma and Boehringer Ingelheim’s collaboration on obesity candidate survodutide, previously known as BI 456906, is now officially moving on to the next phase as the companies initiate more phase III trials with the candidate. 

Danish Zealand Pharma reports this in a stock exchange announcement. 

The trial design in the phase III trials is based on the experience from phase II where people with overweight or obesity achieved a weight loss of up to 19%, according to the announcement. 

”As the prevalence of the disease obesity continues to rise, it is imperative that we develop further innovative approaches to tackle this serious, chronic disease,” says Carel le Roux, a professor at University College Dublin, Ireland, and principal investigator of the trial. He continues:

”Survodutide has a novel mechanism of action with the potential to reduce appetite while increasing liver energy expenditure. The promising phase II data gives us reason to be hopeful about the potential of survodutide as a treatment for people living with obesity.”

The first trial, named Synchronize 1, will investigate survodutide in people who are obese and overweight, i.e. a BMI over 27 with co-morbidities including high cholesterol, high blood pressure, and obstructive sleep apnea but without patients with type 2 diabetes. These latter patients are, however, included in Synchronize 2, the second phase III trial. 

The endpoints in both studies are the percentage change in body weight at week 76 and the proportion of people achieving a weight loss of 5% or more at week 76. Secondary endpoints include other weight loss measures. 

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 phase III trial, named Synchronize-CVOT, will include overweight or obese subjects with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease. The primary endpoint of this study is the time to the first occurrence in subjects of one of five major adverse cardiac events. This can be death, heart failure, or non-fatal stroke. 

It is not clear how many patients will be recruited for the third and final study.

(Translated by DeepL with additional editing by Christian Radich Hoffman)