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Boehringer, Zealand Begin Phase III Program For Obesity Contender Survodutide

Studies Include Cardiovascular Outcomes Trial

 
• By Mandy Jackson

The partners revealed Phase III trial details for GLP-1/glucagon agonist survodutide, where the biggest challenge may be overcoming gastrointestinal side effects seen in Phase II.

Nutritionist sitting at her desk
The three-trial Phase III program will begin enrolling patients soon • Source: Shutterstock

Boehringer Ingelheim GmbH and Zealand Pharma A/S have initiated the Phase III program for their dual agonist of the GLP-1 and glucagon receptors, survodutide, in the treatment of obesity, revealing details on 5 October for three clinical trials designed to demonstrate competitive efficacy and tolerability. After Phase II data showed impressive 18.7% weight loss at the highest dose tested, the Phase III program’s biggest challenge may be to overcome adverse events that led to 28.6% of participants discontinuing treatment.

Key Takeaways

  • Boehringer Ingelheim and Zealand Pharma initiated their Phase III program for GLP-1/glucagon receptor agonist survodutide in obesity with two pivotal trials and a cardiovascular outcomes trial.

  • Survodutide generated significant weight loss in Phase II, but with high discontinuation rates due to adverse events, but a slower titration period in Phase III may reduce gastrointestinal side effect severity

BI and Zealand are developing survodutide (BI 456906) for obesity, but not for type 2 diabetes – unlike GLP-1 agonist class leaders semaglutide, which Novo Nordisk A/S markets as Ozempic for diabetes and Wegovy for obesity, and Eli Lilly and Company’s GLP-1/GIP agonist Mounjaro (tirzepatide), approved in the US for type 2 diabetes and pending Food and Drug Administration approval for obesity later this year

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