Dapiglutide Shows Potential In Latest Zealand Pharma Trial – Low Doses, Big Impact

Zealand Pharma, a company specializing in peptide-based drug development, has released preliminary results from the DREAM trial (Dapiglutide for the Treatment of Obesity). This investigator-led study aimed to assess the efficacy of dapiglutide, a dual GLP-1/GLP-2 receptor agonist, in promoting weight loss and understanding its mechanistic effects over a 12-week period, without incorporating lifestyle changes like diet or exercise.

The trial tested dapiglutide at doses of 4 mg and 6 mg. After 12 weeks, participants experienced an average weight reduction of 2.9% (p=0.483) and 4.3% (p=0.077), respectively, compared to a 2.2% reduction with a placebo, which was the primary endpoint.

David Kendall, MD, Chief Medical Officer of Zealand Pharma, said in a statement “We are encouraged by the reductions in body weight observed in this investigator-led mechanistic trial using low doses of dapiglutide. These results are in line with the outcomes observed with shorter term treatment using lower doses of other incretin-based therapies. Our ongoing 13-week Phase 1b dose-titration trial is currently evaluating higher doses of dapiglutide up to 13 mg, and based on the tolerability profile observed to date, we will seek to investigate even higher doses going forward. We expect topline results from our Phase 1b trial in the second half of this year.”

In the DREAM trial, dapiglutide demonstrated a favorable safety and tolerability profile. The primary side effects were gastrointestinal, such as decreased appetite and nausea. However, these adverse events were less frequent compared to those observed with other incretin-based treatments, and none caused participants to stop the treatment. Further insights into cardiovascular risk, systemic inflammatory markers, and gut biopsy results will be shared at an upcoming scientific conference.