Zealand Pharma Reports Positive Topline Data From 28-Week Phase 1b Clinical Trial Evaluating GLP-1/GLP-2 Dual Agonist Dapiglutide

Zealand Pharma A/S, a biotechnology company developing peptide-based medicines, has reported positive topline results from Part 2 of its Phase 1b multiple ascending dose (MAD) clinical trial evaluating dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist. The trial assessed the safety, tolerability, and clinical effects of dapiglutide administered over a 28-week period. A total of 30 participants, primarily male (approximately 93%), with a median age of 44.5 years, a median starting body weight of 91.9 kg, and a median BMI of 28.8 kg/m², were enrolled in this portion of the study. 

Participants were randomized in a 2:1 ratio to receive either dapiglutide or placebo once weekly for 28 weeks, within a single dose cohort. No lifestyle interventions, such as changes in diet or exercise, were introduced during the trial. By week 28, those treated with dapiglutide experienced an estimated average body weight reduction of 11.6% from baseline, while the placebo group showed a negligible average weight reduction of 0.2%. The higher doses of dapiglutide used in this phase compared to the earlier 13-week Part 1 were considered safe and well tolerated.

David Kendall, MD, Chief Medical Officer of Zealand Pharma, stated “We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population. Dapiglutide is a unique GLP-1 receptor agonist-based therapy, aiming to leverage a dual mechanism that includes GLP-2. Our mid- to late-stage obesity pipeline includes differentiated GLP-1 receptor agonist-based therapies that target people with obesity-related comorbid conditions, and our amylin analog, petrelintide, with potential as a foundational therapy for weight management, addressing unmet needs among the majority of people with overweight and obesity.”

There were no severe or serious treatment-emergent adverse events (TEAEs) reported. Most TEAEs were mild and commonly involved gastrointestinal symptoms, such as nausea and vomiting, which align with observations from other incretin-based therapies. Two participants withdrew from the study due to TEAEs, one due to GI-related symptoms. A small number of participants experienced mild injection site reactions. These findings support the continued development of dapiglutide, with the data suggesting promising weight loss effects and a manageable safety profile.