Boehringer Ingelheim and Zealand Pharma have announced further data showcasing the superior efficacy of survodutide (BI 456906) compared to placebo in individuals with overweight or obesity without type 2 diabetes after 46 weeks of treatment.

The Phase II study included two analyses: planned and actual dose. Participants who completed the study on the 4.8 mg dose achieved a weight loss of nearly 19% in the actual treatment analysis, while the planned treatment analysis demonstrated a weight loss of nearly 15% for all participants assigned to the 4.8 mg dose.

Importantly, the data indicated that bodyweight reductions with survodutide had not plateaued at week 46, suggesting the potential for additional weight loss with longer treatment duration.

After 46 weeks, up to 40% of participants on the highest two doses of survodutide achieved a weight loss of at least 20%, compared to 0% in the placebo group. Moreover, 67% of participants on survodutide 4.8 mg achieved a weight loss of 15% or more, in contrast to only 4.3% of those on placebo.

Carinne Brouillon — Boehringer Ingelheim Head of Human Pharma said: “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.

“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.”

The treatment with survodutide did not reveal any unexpected safety or tolerability issues. Serious adverse events were reported in 4.2% of participants on survodutide compared to 6.5% on placebo. However, treatment discontinuation due to adverse events occurred in 24.6% of participants on survodutide and 3.9% on placebo, primarily due to gastrointestinal adverse events.

Most of these discontinuations took place during the rapid dose-escalation phase, suggesting that a more gradual dose escalation may mitigate these adverse events. The reported adverse events were consistent with expectations for the GLP1-R agonist class of drugs.

The new data highlights the significant potential of survodutide in promoting weight loss in individuals with overweight or obesity. With its superior efficacy and favorable safety profile, survodutide could offer hope for those seeking effective and sustainable weight management solutions.

The findings from this Phase II study provide valuable insights for the future development of survodutide as a potential treatment option.

David Kendall — Zealand Pharma Chief Medical Officer said: “Obesity is one of the most significant healthcare challenges in medicine today.

“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.”

  BI 456906, Boehringer Ingelheim, Carinne Brouillon, David Kendall, obesity, Type 2 Diabetes, weight loss, Zealand Pharma