Zealand Pharma is back with updated findings for its GLP-1/GLP-2 receptor dual agonist, finding mean body weight reductions rose to 11.6% for a higher dosing regimen after 28 weeks in a phase 1b trial.
The Danish biotech’s weight loss candidate, called dapiglutide, was tested among 30 patients who received a weekly dose up to 26 mg of the peptide-based asset, according to top-line results shared in a June 18 release. The majority of trial participants were male, and no lifestyle modifications were included in the study.
The 11.6% number narrowly missed the 12%-plus bar that Jefferies analysts recently said would be encouraging. Based on prior data, the analysts said in a February note that they were cautiously optimistic about the higher dose regimen.
Previously, Zealand had reported a mean placebo-adjusted reduction of up to 8.3% in body weight among 54 people who are overweight or with obesity at 13 weeks, according to a Sept. 9 release. That part of the trial included three dose cohorts of up to 13 mg of dapiglutide or placebo, with more rapid up-titration every second week, compared with the current regimen’s slower every-four-week dose escalation.
But, as William Blair analysts pointed out in a Wednesday note, the latest part 2 data from the phase 1b trial may have underrepresented dapiglutide’s weight loss power, because more than 90% of the trial participants were male, whereas females tend to experience a greater degree of weight loss.
Besides, the Zealand trial enrolled individuals with relatively low baseline body weight and baseline body mass index compared with other trials such as the phase 3 Surmount-1 trial of Eli Lilly’s GLP-1/GIP dual receptor agonist Zepbound (tirzepatide).
The new data demonstrated that higher doses of dapiglutide were well tolerated, according to the biotech. No severe or serious treatment-emergent adverse events (TEAEs) were recorded, though two participants discontinued treatment due to TEAEs, one of which was related to gastrointestinal events.
“We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population,” Zealand Chief Medical Officer David Kendall, M.D., said in the release.
The biotech is aiming to use dapiglutide to treat obesity-related comorbidities driven by low-grade inflammation.
Last year, the company said it intended on moving the asset into a phase 2 trial slated to launch in the first half of this year. The trial is now set to begin in the second half of the year, according to Zealand’s most recent earnings report.
Back in May 2025, dapiglutide failed to impress in a phase 2 trial, mustering up to an average 4.3% reduction in weight loss when given at the 6-mg dose. The 54-person study involved administering either 4-mg weekly subcutaneous doses of dapiglutide, a 6-mg dose or placebo over 12 weeks.
The results suggest that the 4-mg and 6-mg doses are at the “lower end of the therapeutic range,” Zealand said at the time.