Zealand Pharma announces first participant enrolled in Phase 2b ZUPREME-1 trial of petrelintide in people with overweight or obesity

Press Release – No. 12 / 2024

Zealand Pharma announces first participant enrolled in Phase 2b ZUPREME-1 trial of petrelintide in people with overweight or obesity

• Zealand Pharma announces that the first participant has been enrolled in the Phase 2b ZUPREME-1 trial of petrelintide in people with overweight or obesity.
• The Phase 2b ZUPREME-1 trial is designed to evaluate five target doses of petrelintide up to 9 mg over 42 weeks of treatment.
• Completion of enrollment into ZUPREME-1 is expected in the first half of 2025.

Copenhagen, Denmark, December 10, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), 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-1, a global Phase 2b trial in people with obesity or overweight with weight-related co-morbidities comparing once-weekly subcutaneously administered petrelintide, a long-acting amylin analog, versus placebo with regards to effect on body weight, safety, and tolerability¹.

“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 David Kendall, MD, 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.

About ZUPREME-1

ZUPREME-1 is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial (NCT06662539). 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 enroll 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 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.

For more information about the ZUPREME-1 clinical trial of petrelintide, please visit https://clinicaltrials.gov/study/NCT06662539.

About petrelintide

Petrelintide (ZP8396) is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability at neutral pH, minimizing 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.

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.

About Zealand Pharma A/S 

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand 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 was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Forward-Looking Statements

This press release contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company’s clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”, and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release and are based on information available to Zealand Pharma as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Contacts

Neshat Ahmadi (Investors)
Investor Relations Manager
Email: neahmadi@zealandpharma.com  

Adam Lange (Investors)
Investor Relations Officer
Email: alange@zealandpharma.com 

Anna Krassowska, PhD (Media and Investors)
Vice President, Investor Relations & Corporate Communications
Email: akrassowska@zealandpharma.com 

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 December 2024.