Zealand Reports Improved Weight Reduction With Petrelintide In Phase 2 ZUPREME-2 Study

(RTTNews) - Zealand Pharma A/S (ZEAL.CO), a biotechnology company, reported on Wednesday promising topline results from the Phase 2 ZUPREME-2 trial evaluating petrelintide in treating obese or overweight patients with type 2 diabetes.

Petrelintide is a long-acting amylin analog developed for chronic weight management in overweight or obese patients. Amylin is produced by pancreatic-beta cells in response to ingested nutrients and is co-secreted with insulin. By activating amylin receptors, the drug increases sensitivity to the satiety hormone leptin, leading to reduction in body weight over time.

The randomized, double-blind, placebo-controlled, parallel-group, multicenter, U.S.-based Phase 2b ZUPREME-2 study evaluated a once-weekly dose of petrelintide against a placebo over three subcutaneous injections. The trial recruited 220 obese or overweight patients with type 2 diabetes currently being treated with metformin and/or a SLGT2 inhibitor.

Zealand stated that the study met its primary endpoint, as dosed patients exhibited a statistically significant and clinically meaningful reduction in weight by week 28 from the baseline, amounting to 9.2%. The drug also achieved a significant placebo-adjusted reduction in HbA1c levels, for a mean decrease of 0.61%-0.81%.

The most common adverse events were gastrointestinal, with 1.9% discontinuing due to the side effects, comparable to 1.7% on the placebo.

Based on the strength of results from the Phase 2 ZUPREME-1 and ZUPREME-2 trials, Zealand and Roche have initiated three separate Phase 3 studies, namely ZUPREME-3, ZUPREME-4, and ZUPREME-5. The companies plan to recruit 7,000 participants across the trials, as dosing of the first individuals has already begun.

ZEAL.CO closed Wednesday on the Copenhagen Stock Exchange at DKK 249.40, down 0.68%.