Zealand Pharma’s GLP-1/GLP-2 receptor dual agonist showed promising weight loss in an early-stage trial after a previous effort with lower doses ended with “underwhelming” efficacy.
In part one of the Phase 1b multiple ascending dose trial, Zealand’s dapiglutide achieved a placebo-adjusted mean weight reduction of up to 8.3% at 13 weeks. The study enrolled 54 overweight or obese people with a median baseline BMI of 30.0 kg/m2, according to Monday’s release. The trial didn’t include lifestyle changes such as diet and exercise.
Dapiglutide was also well-tolerated with no severe side effects. However, two participants discontinued treatment due to moderate vomiting events and anti-drug antibodies were detected in almost 15% of patients. Part two of the study, which is ongoing, is evaluating higher doses up to 26 mg of dapiglutide over a 28-week period, with a topline readout planned for next year.
In the meantime, the part one data “give us the confidence needed to rapidly progress dapiglutide into a comprehensive Phase 2b trial” set to start in the first half of next year, CMO David Kendall said in the release.
Back in May, some analysts described dapiglutide as producing “underwhelming” weight loss in a Phase 2a trial that evaluated 4 mg and 6 mg doses of the drug. Doses tested in the Phase 1b are more than twice as high.
The company’s “crown jewel” is an amylin analog, petrelintide, that’s set to enter Phase 2b development in overweight and obese people in the second half of the year. Zealand also has a Boehringer Ingelheim-partnered glucagon/GLP-1 receptor dual agonist called survodutide, which the German pharma is testing in a Phase 3 study in obesity.