Zealand Pharma announces completion of enrollment in the Phase 2b ZUPREME-1 trial of petrelintide in people with overweight or obesity
Initiated in December 2024, the Phase 2b ZUPREME-1 trial is designed to evaluate five target doses of petrelintide up to 9 mg over 42 weeks of treatment.
Zealand Pharma remains on track to initiate the Phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes in the first half of 2025.
March 17, 2025 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the last participant has been enrolled and randomized to active treatment or placebo in ZUPREME-1, a global Phase 2b trial in people with obesity or overweight with weight-related comorbidities comparing once-weekly subcutaneously administered petrelintide, a long-acting amylin analog, versus placebo with regards to effects on body weight, safety, and tolerability1.
“We are excited to announce the rapid completion of enrollment and randomization in the Phase 2b ZUPREME-1 clinical trial with petrelintide in people with overweight or obesity, just three months after initiation”, said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “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”.
ZUPREME-1 is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial (ClinicalTrials.gov ID: NCT06662539). The trial compares five doses of once-weekly petrelintide with placebo, when added to a reduced-calorie diet and increased physical activity in people with obesity or overweight with weight-related comorbidities.
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 has enrolled more than 480 participants across 33 sites in the United States, Poland, and Romania.
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 hemoglobin 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.
Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation and co-administration with other peptides2. Amylin is produced in the pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Amylin receptor activation has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin3,4, inducing a sense of feeling full faster. Current clinical data 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.
In November 2024, Zealand Pharma presented detailed results from the Phase 1b 16-week multiple ascending dose (MAD) trial at the Obesity Society Annual Meeting (ObesityWeek) 2024. For the presentation, please visit Scientific publications - Pipeline - Zealand Pharma.
In March 2025, Zealand Pharma and Roche entered a collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity. The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the agreement will close in the second quarter of 2025.
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S.
Sources
1. ClinicalTrials.gov. Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities (ZUPREME). Available at https://clinicaltrials.gov/study/NCT06662539. Last accessed March 2025.
2. Eriksson et al. Presentation at ObesityWeek, November 1–4, 2022, San Diego, CA. Link: https://www.zealandpharma.com/media/0gnfxg4b/zp8396-sema-coformulation-obesityweek-2022.pdf.
3. Mathiesen et al. Eur J Endocrinol 2022;186(6):R93–R111.
4. Roth et al. Proc Natl Acad Sci U S A 2008;105(20):7257–7262.
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