Zealand Pharma Begins Phase 2b ZUPREME-2 Trial for Petrelintide

Zealand Pharma announces first participant enrolled in Phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes

The Phase 2b ZUPREME-2 trial investigates the efficacy and safety of petrelintide in participants with overweight or obesity and type 2 diabetes.
The ZUPREME-2 trial is designed to evaluate three doses of petrelintide up to 9 mg over 28 weeks of treatment.
Completion of enrollment in ZUPREME-2 is expected in the second half of 2025. a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the first participant has been enrolled in ZUPREME-2, a Phase 2b trial in people with overweight or obesity and type 2 diabetes comparing once-weekly subcutaneously administered petrelintide, a long-acting amylin analog, versus placebo with regards to efficacy and safety1.

“We are excited to announce the initiation of ZUPREME-2, the second Phase 2 trial initiated with petrelintide and an important part of our clinical development plan for establishing petrelintide as a best-in-class alternative to incretin-based therapies and a future foundational therapy for weight management”, said David Kendall, MD, Chief Medical Officer at Zealand Pharma. “Amylin agonism has shown great potential to provide clinically meaningful weight loss and may also provide additional improvements in glycemic control in people with overweight or obesity and type 2 diabetes, and we look forward to evaluating the efficacy and safety of petrelintide as a weight loss therapy in this population.""

About ZUPREME-2

ZUPREME-2 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 2b clinical trial (NCT06926842). The trial will compare three doses of once-weekly petrelintide with placebo, when added to a reduced-calorie diet and increased physical activity in participants with overweight or obesity and type 2 diabetes.

The trial includes a screening period, a dose escalation treatment period up to 16 weeks with dose escalation every fourth week followed by a maintenance treatment period until week 28, and a follow-up period after treatment is completed until week 38. ZUPREME-2 is expected to enroll a total of approximately 200 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, body weight loss of ≥5% and ≥10%, absolute change in body weight, change in waist circumference, change in hemoglobin A1c (HbA1c), change in high-sensitivity C-reactive protein (hsCRP), change in fasting glucose, and change in fasting lipids.

For more information about the ZUPREME-2 clinical trial of petrelintide, please visit https://clinicaltrials.gov/study/NCT06926842.

About petrelintide

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.

Petrelintide is also being evaluated in ZUPREME-1, a Phase 2 trial in participants with overweight or obesity (NCT06662539), evaluating five target doses of petrelintide up to 9 mg over 42 weeks of treatment. Enrollment and randomization in ZUPREME-1 was completed in three months. 

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.

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