Zealand Pharma’s investigational obesity drug survodutide delivered sustained weight loss and improved blood sugar control in people with obesity or overweight and type 2 diabetes, according to results from a pivotal Phase III trial.

 

The company said Boehringer Ingelheim’s SYNCHRONIZE-2 trial met both of its co-primary endpoints, measuring percentage change in body weight and the proportion of patients achieving at least 5% weight loss.

 

After 76 weeks of treatment, patients receiving survodutide achieved average weight loss of up to 13.1%, compared with 3.1% for those receiving placebo, based on the efficacy estimand. The difference was statistically significant.

 

The trial also found that up to 79.3% of patients treated with survodutide lost at least 5% of their body weight, compared with 32.7% in the placebo group.

 

“We are very encouraged by the SYNCHRONIZE-2 results reported today by Boehringer Ingelheim, demonstrating the potential of survodutide in people living with obesity and type 2 diabetes, by providing both meaningful weight loss and glycemic control. 

 

'The results reported today add to the growing body of evidence from the broad SYNCHRONIZE program, further reinforcing the novel mechanism of survodutide and its ability to potentially address not only obesity, but also the underlying disease drivers and associated metabolic health consequences,” said David Kendall, Chief Medical Officer of Zealand Pharma. 

 

“We remain encouraged by Boehringer Ingelheim’s commitment to bring survodutide to patients living with overweight or obesity and associated metabolic dysfunction and look forward to SYNCHRONIZE-CVOT results later this year.”

 

The results extended beyond weight loss, with patients receiving survodutide showing significant improvements in several cardiometabolic measures.

 

HbA1c fell by as much as 1.21 percentage points from a baseline of 7.4%, compared with a 0.03-point reduction in the placebo group.

 

Patients taking survodutide also recorded an 11.1 cm reduction in waist circumference, compared with 3.5 cm for placebo.

 

The company said patients showed improvements in fasting glucose, insulin resistance and insulin secretion. Up to 29.5% of patients receiving survodutide reverted to normoglycemia, defined as HbA1c below 5.7%, compared with 4.0% in the placebo group.

 

“Obesity and type 2 diabetes are deeply intertwined, with excess weight increasing the risk of T2D. For people living with these conditions, sustained weight loss is often a biological struggle rather than a lack of willpower,” said Sean Wharton, Coordinating Investigator of the SYNCHRONIZE-2 trial. 

 

“These results are encouraging because, in obesity medicine, clinicians increasingly recognize the opportunity to address multiple interconnected health conditions together. Seeing improvements in glycemic control and insulin sensitivity alongside weight loss provides evidence that tackling obesity can positively influence broader metabolic health. This brings new optimism to people seeking more effective ways to improve their overall health.”

 

Survodutide is an investigational glucagon/GLP-1 receptor dual agonist designed to target multiple metabolic pathways. The drug is being developed to reduce appetite, improve glycemic control and reduce liver fat.

 

“The growing body of evidence from our SYNCHRONIZE Phase III program continues to strengthen our understanding of survodutide’s potential in people living with obesity, including those with type 2 diabetes. 

 

"The SYNCHRONIZE-2 results demonstrate meaningful weight loss alongside improvements in glycemic control and other key markers of metabolic health, reinforcing our belief that obesity should be addressed as a complex chronic disease with interconnected health consequences," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. 

 

“We remain committed to advancing innovative treatment approaches that address the diverse needs of people living with obesity across different stages of disease and risk profiles.”

 

The most commonly reported adverse events were gastrointestinal, including nausea, vomiting, diarrhea and constipation. Most were described as mild to moderate.

 

However, 18% of patients receiving survodutide discontinued treatment because of gastrointestinal adverse events, compared with 1.2% in the placebo group.

 

The company said discontinuations generally occurred during the dose-escalation phase. It added that newer and upcoming trials are using more flexible, patient-centered titration strategies intended to improve tolerability.