INGELHEIM, GERMANY & COPENHAGEN, DENMARK-- June 25, 2023 -- Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced additional data demonstrating superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment.1 The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S.

The Phase II study included two analyses: planned (assigned dose at randomization, which was also the primary endpoint) and actual (dose at the end of treatment).1 People who completed the study on the 4.8 mg dose (actual treatment analysis) achieved nearly 19% weight loss.1 As previously announced, the planned treatment analysis demonstrated nearly 15% weight loss for all those randomized to the 4.8 mg dose.1 Bodyweight reductions with survodutide had not reached a plateau at week 46, suggesting additional weight loss could be achieved with longer treatment duration.1

“Given the prevalence of obesity and its many disease-related complications, there is a dire need for treatments that can help treat the disease of obesity effectively,” said Carel le Roux, MD, Ph.D., Professor at University College in Dublin, Ireland, and Principal Investigator of the trial. “Current treatments for obesity mainly focus on weight loss by reducing energy intake.2 By activating both the glucagon and GLP-1 receptors, survodutide may both inhibit appetite and improve energy expenditure, thereby helping to treat the disease of obesity.2 These encouraging data support the further study of survodutide in larger Phase III trials.”

After 46 weeks of treatment, up to 40% of people who reached the highest two doses of survodutide achieved a weight loss of at least 20%, versus 0% with placebo.1 Body weight loss of 15% or more was achieved by 67% of people who reached survodutide 4.8 mg versus 4.3% of those on placebo.1

Treatment with survodutide did not show unexpected safety or tolerability issues. Serious adverse events were reported by 4.2% of participants on survodutide versus 6.5% of those on placebo.1 Treatment discontinuation due to adverse events occurred in 24.6% and 3.9% of participants, respectively, mainly due to gastrointestinal adverse events.1 Most treatment discontinuations due to adverse events occurred during the rapid dose-escalation phase and may potentially be mitigated with more gradual dose escalation.1 The adverse events reported were similar to those expected with the GLP1-R agonist class of drugs.1

“With our long heritage in researching and developing new treatments for cardiovascular, renal, and metabolic conditions, we are extremely encouraged by these robust and compelling Phase II data,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “Survodutide may become the first anti-obesity medication to reduce appetite while increasing energy expenditure through the liver. We look forward to furthering our discussions with health authorities to advance this dual receptor agonist into Phase III trials as we aim to help fill a treatment gap in this disease area.”

“Obesity is one of the most significant healthcare challenges in medicine today,” said David Kendall, M.D., Chief Medical Officer, Zealand Pharma. “At Zealand Pharma, we have both experience and success in discovering and developing peptide therapeutics that target key metabolic pathways - designed to help people living with overweight and obesity by achieving substantial weight loss while addressing the many complications of this disease.”