Zealand Pharma A/S announces “positive” topline clinical results from Part 2 of a Phase 1b multiple ascending dose, or MAD, trial, investigating safety, tolerability, and clinical effects of 16 weeks of dosing with petrelintide, a long-acting amylin analog in development for weight management. In Part 2 of the Phase 1b MAD trial, a total of 48 participants with a median age of 49 years and a median baseline BMI of 29 kg/m2, were randomized to receive 16 weekly doses of either petrelintide or placebo within three dose cohorts. The mean body weight decreased by 8.6% from baseline among participants completing treatment with high dose petrelintide while placebo resulted in a mean body weight decrease of 1.7% from baseline. “The data reported from this 16-week trial are both exciting and compelling, demonstrating significant and clinically meaningful reductions in body weight with a very favorable tolerability profile. These results support our conviction that petrelintide is very well tolerated and can potentially play an important role as an alternative to incretin-based therapies for the management of overweight and obesity. These data pave the way for rapid progression to Phase 2b trials of petrelintide and further support the potential of this long-acting amylin analog to deliver weight loss comparable to GLP-1 receptor agonists with a better patient experience. We look forward to initiation of the Phase 2b clinical trial of petrelintide in people living with overweight and obesity later in 2024,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma.
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