Zealand Pharma A/S presented data from its Phase 1 trial of dapiglutide at the 82nd Scientific Sessions of the American Diabetes Association (ADA) in New Orleans and announced it will be supporting a Phase 2 investigator-initiated clinical trial of dapiglutide in obesity anticipated to commence by early 2023. The Phase 1 results of dapiglutide, a GLP-1R/GLP-2R dual agonist, demonstrated dose dependent weight loss of up to 4.3% of baseline body weight after only four weeks of treatment. No patients developed anti-drug antibodies.

The pharmacokinetics (PK) showed dose proportionality with a low inter-subject variability and a mean half-life of 123-129 hours across the four dose cohorts and supported that dapiglutide is suitable for once-weekly dosing. Dapiglutide also demonstrated an acceptable safety profile and was found to be appropriate for once weekly injection. Multiple doses of dapiglutide were well-tolerated and the safety profile as expected for GLP-1 and GLP-2 receptor agonists.

There were no serious or severe adverse events (AEs) and no withdrawals. The most frequent related AEs reported were gastrointestinal disorders and metabolism and nutrition disorders as expected from marketed GLP-1RAs.