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.
Copenhagen, Denmark, 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”.
About ZUPREME-1
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.
About Zealand Pharma
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. For more information about Zealand Pharma’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 pre-clinical and 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, patient recruitment 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 at third party manufacturers; dependency on third parties, for instance contract research or development organizations; 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 labelling; 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 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
Anna Krassowska, PhD (Investors and Media) Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: akrassowska@zealandpharma.com
Adam Lange (Investors) Investor Relations Officer Zealand Pharma Email: alange@zealandpharma.com
