Zealand Pharma announces topline results from Phase 1b trial of dapiglutide

Zealand Pharma announces topline clinical results from a Phase 1b multiple ascending dose trial, investigating safety, tolerability, and clinical effects of 13 weeks of dosing with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist in development for weight management. In Part 1 of the Phase 1b trial, a total of 54 participants with a median age of 46 years and a median baseline BMI of 30.0 kg/m2 were randomized to receive 13 weekly doses of either dapiglutide or placebo within three dose cohorts. At week 13, the estimated mean body weight had decreased by up to 8.3% on a placebo-corrected basis among participants on dapiglutide treatment. No lifestyle modifications, such as diet or exercise, were included in the trial. Dapiglutide was assessed to be safe and well-tolerated in Part 1 of the trial, with no severe treatment-emergent adverse events and one serious AE, which was deemed not related to the drug. The most common TEAEs were gastrointestinal including nausea and vomiting. Only two participants discontinued treatment due to AEs, which were related to the GI system. Overall, the number of GI events observed were consistent with clinical trials of other incretin-based therapies with a similar, rapid dose escalation scheme. A low number of participants reported injection site reactions, all of which were mild. Anti-drug antibodies were observed in 14.3% of participants. Part 2 of this Phase 1b trial is evaluating higher doses of dapiglutide up to 26 mg over a 28-week treatment period with up-titration every fourth week. Zealand expects to report topline results from Part 2 in the first half of 2025 and present further details from Part 1 and Part 2 of this Phase 1b trial at a future scientific congress. The company plans to progress the clinical development of dapiglutide into a Phase 2b trial in people living with overweight and obesity, with initiation expected in the first half of 2025. Also, the company expects to evaluate the potential of dapiglutide in select obesity-related comorbidities.