COPENHAGEN, Denmark — September 30, 2026
Zealand Pharma announced additional data from the Phase 2 ZUPREME-1 trial of investigational petrelintide and the publication of trial results in The Lancet Diabetes & Endocrinology. The randomized, double-blind, placebo-controlled study evaluated once-weekly petrelintide in adults with obesity or overweight and weight-related comorbidities. Among the evaluated participants, petrelintide produced mean body-weight reductions of up to 10.7% at week 42 compared with 1.7% for placebo using the efficacy estimand. Zealand also reported generally mild gastrointestinal adverse events at rates similar to placebo, alongside improvements in several cardiometabolic risk factors. The company has initiated a global Phase 3 registrational program evaluating petrelintide for chronic weight management.
ZUPREME-1 Shows Double-Digit Weight Loss
ZUPREME-1 randomized participants to five once-weekly subcutaneous doses of petrelintide or placebo over a 42-week treatment period. The trial evaluated doses ranging from 1.0 mg to 9.0 mg and included dose escalation followed by maintenance treatment. Using the treatment policy estimand, mean body-weight reductions reached 10.2% at week 42 versus 1.4% with placebo. The study also assessed waist circumference, HbA1c, hsCRP, fasting lipids and fasting glucose as secondary measures. Zealand said the findings support continued development of petrelintide while the Phase 3 program evaluates the candidate in larger registrational studies.
Petrelintide Shows Cardiometabolic Improvements
Treatment with petrelintide was associated with improvements in several cardiometabolic risk factors in ZUPREME-1. Waist circumference declined by up to 10.8 cm versus 4.3 cm with placebo, while high-sensitivity C-reactive protein decreased by up to 41% compared with 6% for placebo. Triglycerides declined by as much as 21% versus 9%, and mean pulse rate decreased by up to 2.9 beats per minute compared with a 0.3 bpm increase with placebo. Gastrointestinal adverse events were generally mild and occurred at rates comparable to placebo; at the maximally effective dose, Zealand reported no vomiting cases and no treatment discontinuations due to gastrointestinal adverse events. These Phase 2 findings require confirmation in the larger Phase 3 registrational program.
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Zealand Advances Petrelintide Into Phase 3
Petrelintide is a long-acting human amylin analog designed for once-weekly subcutaneous administration and is being developed for chronic weight management. Zealand is evaluating the candidate in three global Phase 3 registrational trials following the ZUPREME-1 results. In 2025, Zealand Pharma and Roche entered an exclusive collaboration and licensing agreement to co-develop and co-commercialize petrelintide for people living with overweight and obesity. Zealand also plans to evaluate petrelintide in combination with enicepatide in a Phase 2 study. While the Phase 2 findings provide clinical evidence of weight loss and changes in selected metabolic measures, petrelintide remains investigational and its long-term efficacy, safety and clinical benefits will be assessed in ongoing and future studies.
Source :Zealand Pharma press release
