Zealand Pharma announces initiation of the registrational Phase 3 ZUPREME program of petrelintide in people with overweight or obesity
Press release – No. 17 / 2026
Zealand Pharma announces initiation of the registrational Phase 3 ZUPREME program of petrelintide in people with overweight or obesity
- The Phase 3 initiation marks a defining step toward establishing petrelintide as a future first-choice therapy for millions of people living with overweight or obesity
- The global Phase 3a ZUPREME program consists of three trials, designed to support marketing applications for petrelintide monotherapy in chronic weight management
- The Phase 3a program builds on positive Phase 2 results, which demonstrated double-digit weight loss with a tolerability profile largely comparable to placebo, supporting petrelintide’s potential to redefine the weight management experience for people living with obesity or overweight
Copenhagen, Denmark, September 22, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announces the initiation of the global registrational Phase 3 ZUPREME program, evaluating the efficacy and safety of once-weekly petrelintide versus placebo in people with overweight or obesity.
The Phase 3a program for petrelintide monotherapy, which is being conducted with Zealand Pharma’s partner Roche, consists of three trials: ZUPREME-3, ZUPREME-4, and ZUPREME-5, evaluating the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity or overweight without type 2 diabetes, people with obesity or overweight with type 2 diabetes, and people with obesity or overweight and established cardiovascular disease, respectively. The three trials are expected to enroll approximately 7,000 participants in total.
“The Phase 3a program is designed to confirm the first-choice potential of petrelintide – supported by the data we have seen throughout the clinical trials with petrelintide: clinically meaningful double-digit weight reduction and a tolerability profile that supports the long-term adherence that chronic weight management requires,” said David Kendall, MD, Chief Medical Officer at Zealand Pharma. ”The program is designed to generate the robust, longer-term evidence needed to support regulatory filings and bring petrelintide to the millions of people demanding a better weight management experience.”
About the Phase 3a ZUPREME program
ZUPREME-3 is a randomized, double-blind, placebo-controlled, Phase 3 trial, evaluating the efficacy and safety of once-weekly petrelintide compared with placebo in participants living with overweight (BMI ≥ 27 < 30 kg/m2) or obesity (BMI ≥ 30 kg/m2) with at least one weight-related comorbidity without type 2 diabetes (T2D). The trial will enroll a total of approximately 3,900 participants.
ZUPREME-4 is a randomized, double-blind, placebo-controlled, Phase 3 trial, evaluating the efficacy and safety of once-weekly petrelintide compared with placebo in participants living with overweight or obesity and T2D. The trial will enroll a total of approximately 600 participants.
The ZUPREME-3 and ZUPREME-4 trials include a screening period, a dose escalation period of 12 weeks followed by a maintenance period until week 64, and a safety follow-up period after treatment is completed until week 77. All participants who complete the week 64 visit will be eligible to continue in an optional open-label extension (OLE) study. Participants in the OLE study will be offered treatment with petrelintide regardless of which treatment arm they were allocated in the main study.
ZUPREME-5 is a randomized, double-blind, placebo-controlled, Phase 3 trial, evaluating the efficacy and safety of once-weekly petrelintide in participants living with overweight or obesity and established cardiovascular disease (CVD) with or without T2D. ZUPREME-5 includes a screening period, a dose escalation period of 12 weeks followed by a maintenance period, with the primary efficacy assessment occurring at week 64. Following the primary assessment, participants continue into an event-maintenance phase. The trial can last up to a total of 3 years and will enroll a total of approximately 2,500 participants.
The primary endpoint in the Phase 3 ZUPREME trials is percentage change in body weight from baseline to week 64. Secondary endpoints include, but are not limited to, change in waist circumference, HbA1c, cardiometabolic risk factors, physical functioning, and change in eating behaviors.
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 peptides1. Human 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 leptin2,3, inducing a sense of feeling full faster.
In 2025, Zealand Pharma and Roche entered into an exclusive collaboration and licensing agreement to co-develop and co-commercialize petrelintide for people living with overweight and obesity. Petrelintide is currently being developed for chronic weight management as both a monotherapy agent and in combination with Roche’s GLP-1/GIP receptor dual agonist enicepatide (CT-388). A Phase 2 trial evaluating the combination of petrelintide and enicepatide (CT-388) is planned for initiation in the second half of 2026.
About Zealand Pharma
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.
To date, more than ten Zealand Pharma invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.
Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Cambridge, Massachusetts. Learn more at 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 affect 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. 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 company announcement and are based on information available to Zealand Pharma as of the date of this announcement. 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
Eric Rojas (Investors)
Vice President, Head of Investor Relations
Zealand Pharma
Email: erojas@zealandpharma.com
Neshat Anis Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
Email: neahmadi@zealandpharma.com
Rachel James-Owens (Media)
Vice President, Corporate Communications & Media Relations
Zealand Pharma
Email: rjamesowens@zealandpharma.com
Andreas Hylleberg Mølleskov (Media)
Director, External Communications
Zealand Pharma
Email: ahylleberg@zealandpharma.com
Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
Email: zealandpharma@icrhealthcare.com
+44 (0) 7739 658 783
References
1. 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.
2. Mathiesen et al. Eur J Endocrinol 2022;186(6):R93–R111.
3. Roth et al. Proc Natl Acad Sci U S A 2008;105(20):7257–7262
