Zealand Pharma announces results from 28-week Phase 1b trial of dapiglutide

Zealand Pharma (ZLDPF) announced topline clinical results from Part 2 of a Phase 1b multiple ascending dose trial, investigating safety, tolerability, and clinical effects of 28 weeks of treatment with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist. “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,” said David Kendall, CMO. “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.” In this Part 2 of the Phase 1b MAD trial, a total of 30 participants with a median age of 44.5 years, a median baseline body weight of 91.9 kg, and a median baseline BMI of 28.8 kg/m2 were randomized to receive 28 weekly doses of either dapiglutide or placebo within one dose cohort. At week 28, the estimated mean body weight decreased by 11.6% from baseline among participants on dapiglutide treatment. Placebo treatment resulted in a mean body weight decrease of 0.2% from baseline. No lifestyle modifications, such as diet or exercise, were included in the trial. Higher doses of dapiglutide compared to the prior 13-week Part 1 of the trial were assessed to be safe and well-tolerated in the trial, with no severe or serious treatment-emergent adverse events reported. The vast majority of TEAEs were mild and the most common were gastrointestinal, including nausea and vomiting. Two participants withdrew due to TEAEs, one of which was related to GI events. Overall, the number of GI events observed was consistent with clinical trials of other incretin-based therapies. A low number of participants reported injection site reactions, all of which were mild.