Zealand Pharma has concluded enrolment for its global, randomised Phase IIb ZUPREME-1 trial, assessing the long-acting amylin analogue, petrelintide, in individuals with obesity or overweight and related comorbidities.
The placebo-controlled, multi-centre, parallel-group study is designed to compare the one-time-a-week subcutaneous administration of the therapy against a placebo related to tolerability, safety, and effects of the body weight.
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It enrolled more than 480 subjects across 33 sites in Poland, Romania, and the US.
The study is designed to compare five doses of the therapy against a placebo, alongside a decreased-calorie diet and increased physical activity.
The primary endpoint of this trial is the percentage change in weight of the body from baseline to week 28, with secondary endpoints, including changes in the circumference of the waist, change in high-sensitivity C-reactive protein (hsCRP), fasting lipids, haemoglobin A1c (HbA1c), as well as fasting glucose.
Additionally, an exploratory endpoint will assess changes in body composition at week 42 using magnetic resonance imaging (MRI).
Zealand Pharma chief medical officer David Kendall said: “We are excited to announce the rapid completion of enrolment and randomisation in the Phase IIb ZUPREME-1 clinical trial.
“This achievement reflects both the strong interest in amylin agonists from the clinical community and highlights the importance of developing new treatment options that can leverage distinct mechanisms of action to better serve those living with overweight and obesity.”
According to the company, petrelintide is tailored to be chemically and physically stable and can be co-formulated with other peptides.
Its mechanism of action involves the activation of the amylin receptor, which has been associated with weight reduction by restoring leptin sensitivity and promoting satiety.
In a recent development, the company has entered a partnership and licence agreement with Roche to jointly develop and commercialise the therapy, with expectations to close the agreement in the second quarter of this year, pending regulatory approvals.
In July 2023, Zealand reported positive outcomes from part one of the multiple-ascending dose trial of ZP8396 targeting obesity management.
