Zealand Pharma has enrolled the first participant has been enrolled in ZUPREME-1, a global Phase 2b trial in people with obesity or overweight with weight-related co-morbidities comparing once-weekly subcutaneously administered petrelintide (ZP8396) versus placebo with regards to effect on body weight, safety and tolerability.
Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability at neutral pH, minimising fibrillation and allowing for co-formulation with other peptides. Amylin is produced in the pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Current clinical or pre-clinical data suggest a potential of petrelintide to deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability for a better patient experience and high-quality weight loss by preserving lean mass.
ZUPREME-1 is a randomised, double-blind, placebo-controlled, parallel-group, multinational, multi-centre, dose-finding, Phase 2 clinical trial. The trial will compare five doses of once-weekly petrelintide with placebo, when added to a reduced-calorie diet and increased physical activity in participants with obesity or overweight with weight-related co-morbidities.
The trial includes a screening period, a dose escalation period up to 16 weeks with dose escalation every fourth week followed by a maintenance period until week 42, and a follow-up period after treatment is completed until week 51. ZUPREME-1 is expected to enrol a total of 480 participants across 33 sites in the US, Poland and Romania. To ensure an approximate gender balance in the trial, there will be a recruitment limit of maximum 60% of either male or female trial participants.
The primary endpoint in the trial is the percentage change in body weight from baseline to week 28. Secondary endpoints include, but are not limited to, percentage change in body weight from baseline to week 42, change in waist circumference, change in haemoglobin A1c (HbA1c), change in high-sensitivity C-reactive protein (hsCRP), change in fasting lipids, and change in fasting glucose. Change in body composition at week 42 measured by magnetic resonance imaging (MRI) is included as an exploratory endpoint in the trial.
“The initiation of this large and comprehensive Phase 2b trial of petrelintide in people with overweight or obesity marks an important milestone for Zealand. Backed by strong and compelling clinical data reported to date, we are highly encouraged by the potential of petrelintide to represent a best-in-class alternative to incretin-based therapies and a future foundational therapy for weight management,” said Dr David Kendall, Chief Medical Officer at Zealand Pharma. “We are expanding the development program for petrelintide and look forward to initiating the Phase 2b trial of petrelintide in people with overweight or obesity with type 2 diabetes in the first half of 2025.
For more information about the ZUPREME-1 clinical trial of petrelintide, please click here
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