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Zealand Pharma announces first participant enrolled in Phase 2b ZUPREME-2 trial of petrelintide in people with overweight or obesity and type 2 diabetes
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.
Copenhagen, Denmark, April 24, 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 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.
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.
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. 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
Adam Lange (Investors) Vice President, Investor Relations Zealand Pharma Email: alange@zealandpharma.com
Anna Krassowska, PhD (Investors and Media) Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: akrassowska@zealandpharma.com
Sources
1. ClinicalTrials.gov. Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2). Available at https://clinicaltrials.gov/study/NCT06926842. Last accessed April 2025.
