Zealand Pharma reports positive Phase 2 petrelintide results

Company announcement -- No. 7% in placebo group) - Data reinforce potential of petrelintide as a future first choice therapy for chronic weight management Copenhagen, Denmark, October 7, 2026 -- Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 0%). The trial met its primary endpoint, demonstrating that once-weekly subcutaneous injections of petrelintide (escalated every fourth week) resulted in statistically significant and clinically meaningful reductions in body weight from baseline after 28 weeks in all three treatment arms compared to placebo.

0% with placebo, with results remaining largely consistent under the treatment regimen estimand. 88%. "These results further support the potential of petrelintide in chronic weight management and, for the first time, demonstrate its promise as a standalone treatment for those living with overweight or obesity and type 2 diabetes," said David Kendall, MD, Chief Medical Officer at Zealand Pharma. "These data confirm the potential for clinically meaningful weight reduction with a promising and favorable tolerability profile.

We are also encouraged by the improvements in glycemic control - a combination essential for supporting long-term, sustained benefits in people living with obesity and type 2 diabetes. " No unexpected safety signals were observed with petrelintide treatment. Petrelintide demonstrated a favorable tolerability profile largely comparable to placebo. 7% with placebo.

The most frequently reported AEs were gastrointestinal-related, the vast majority of which were mild and occurred during the escalation period. The safety and tolerability profile of petrelintide observed in ZUPREME-2 confirms the findings of the 42-week Phase 2 ZUPREME-1 trial in people with overweight or obesity without type 2 diabetes. The full trial results from ZUPREME-2 are expected to be presented at an upcoming scientific conference.

Zealand Pharma and Roche have started a Phase 3a program for petrelintide which 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 and the first individuals have initiated treatment. For more information about the Phase 3 program, refer to Zealand Pharma Press Release no. 17 / 2026.

This company announcement discloses inside information pursuant to Article 17 of the Market Abuse Regulation (EU) No 596/2014. About ZUPREME-2 ZUPREME-2 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, US-based Phase 2b clinical trial (NCT06926842). The trial compared 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 on metformin with or without an SGLT2 inhibitor.

The trial included 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 was completed until week 38. ZUPREME-2 enrolled a total of 220 participants in the United States. 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 About petrelintide Petrelintide is a long-acting human 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 peptides(1).

The hormone 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 leptin(2,3), 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 A/S 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. S. presence in Cambridge, Massachusetts.

Learn more at Forward-looking statements This company announcement 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 and the company's significant events and potential catalysts in 2026 and financial guidance for 2026.

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 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 (MORE TO FOLLOW) Dow Jones Newswires October 07, 2026 13:13 ET (17:13 GMT) The statements in this document shall not be considered as an objective or independent explanation of the matters.

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