Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide

Core Insights - Zealand Pharma A/S announced positive topline results from a 28-week Phase 1b trial of dapiglutide, a dual GLP-1/GLP-2 receptor agonist, indicating significant weight loss and safety [2][3][4] Group 1: Trial Results - In the Phase 1b trial, 30 participants (approximately 93% male) experienced an estimated mean body weight decrease of 11.6% from baseline after 28 weeks of dapiglutide treatment, compared to a 0.2% decrease in the placebo group [3][8] - The trial showed that dapiglutide was safe and well-tolerated, with no severe treatment-emergent adverse events reported, and the majority of adverse events were mild gastrointestinal issues [4][8] Group 2: Trial Design - The Phase 1b trial was a single-center, randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of dapiglutide in participants with overweight or obesity [5][6] - Part 1 of the trial included 54 participants and demonstrated placebo-adjusted weight reductions of up to 8.3% after 13 weeks, while Part 2 involved 30 participants receiving 28 weekly doses of dapiglutide [6][7] Group 3: Drug Mechanism and Target Population - Dapiglutide is designed to leverage a dual mechanism involving GLP-1 and GLP-2, targeting obesity-related comorbid conditions driven by low-grade inflammation [9][10] - The drug aims to improve intestinal barrier function and address comorbidities associated with obesity, such as cardiovascular disease and liver disease [10]