Zealand Pharma reports positive Phase 2 for Petrelintide

Zealand Pharma reports positive Phase 2 for Petrelintide

Zealand Pharma A/S (Nasdaq: ZEAL) announced the completion of enrollment in its Phase 2b ZUPREME-1 trial of petrelintide, a long-acting amylin analog, for the treatment of overweight or obesity with weight-related comorbidities. The trial, initiated in December 2024, enrolled over 480 participants across 33 sites in the U.S., Poland, and Romania, and evaluates five doses of once-weekly subcutaneous petrelintide versus placebo over 42 weeks of treatment according to the company's announcement. The primary endpoint measures percentage change in body weight from baseline to week 28, with secondary endpoints including changes in waist circumference, HbA1c, and fasting glucose, among others as reported in the trial details.

The company also confirmed plans to initiate the Phase 2b ZUPREME-2 trial in people with overweight or obesity and type 2 diabetes by mid-2025 according to the company's update. In March 2025, Zealand Pharma and Roche entered a collaboration and license agreement to co-develop and co-commercialize petrelintide, pending regulatory approvals, with an expected closing in Q2 2025 as part of their strategic partnership. This partnership could provide Zealand with financial and operational support for late-stage development.

Preclinical and Phase 1b trial data suggest petrelintide may offer weight loss comparable to GLP-1 receptor agonists with improved tolerability according to preclinical findings. However, the ZUPREME-1 trial's results remain pending, and no efficacy or safety data have been disclosed to date. Investors should note that regulatory and clinical risks, including delays or adverse outcomes, could impact the program's timeline and commercial potential.