Zealand Pharma A/S announced topline results from the DREAM trial (Dapiglutide for the Treatment of Obesity), the investigator-led clinical trial designed to evaluate the potential for weight loss and to gain key mechanistic insights into the effects of low doses of GLP-1/GLP-2 receptor dual agonist dapiglutide following a 12-week treatment period. No lifestyle interventions, such as diet or exercise, were part of the trial. Treatment with dapiglutide at doses of 4 and 6 mg resulted in an observed numerical mean weight loss change from baseline of 2.9% (p=0.483) and 4.3% (p=0.077) after 12 weeks, respectively, compared to 2.2% with placebo (primary endpoint).
Dapiglutide was assessed to be safe and well-tolerated in the DREAM trial. The most common treatment-emergent adverse events were related to the gastrointestinal system, including reduced appetite and nausea. Overall, the number of events observed were lower than have been reported from studies of other incretin-based therapies, and none led to treatment discontinuation in this trial.
Additional detailed results on cardiovascular risk, systemic inflammatory markers, as well as data from gut biopsies, will be presented at a future scientific meeting.