Press release – No. 18 / 2026
Zealand Pharma to present additional data from Phase 2 ZUPREME-1 trial for petrelintide at EASD 2026 and announces publication of trial results in The Lancet Diabetes & Endocrinology
- Treatment with petrelintide was associated with clinically meaningful, double-digit weight loss, with a gastrointestinal tolerability profile comparable to placebo
- Treatment was associated with significant improvements in cardiometabolic disease risk factors, including reductions in pulse rate, high-sensitivity C-reactive protein and waist circumference
- Additional results from the ZUPREME-1 study will be presented in an oral presentation at EASD 2026 on September 30 at 3:30pm CEST
- A global Phase 3 ZUPREME registrational program with petrelintide monotherapy for chronic weight management has been initiated
Copenhagen, Denmark, September 30, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announces that results from its Phase 2 ZUPREME-1 trial evaluating investigational petrelintide have been published in The Lancet Diabetes & Endocrinology. The data will be presented at the 62nd Annual meeting of the European Association for the Study of Diabetes (EASD) 2026 on September 30, 2026, at 3:30pm CEST.
In the randomized, double-blind, placebo-controlled, dose-finding ZUPREME-1 trial, 485 adults (53% female; mean age 47 years; BMI 36.7 kg/m²; body weight 107.1 kg) were randomly assigned (5:1) to once-weekly subcutaneous injections of petrelintide at 1.0 mg, 2.5 mg, 5.0 mg, 7.0 mg or 9.0 mg, or to placebo, for 42 weeks including dose escalation.
Data reinforce the potential of petrelintide to enhance treatment persistence and address current challenges of treatment durability, tolerability and acceptability.
Key Findings
- Petrelintide led to mean reductions in body weight from baseline to week 42 of up to 10.7% vs 1.7% for placebo (efficacy estimand)
- Using the treatment policy estimand, petrelintide led to mean reductions in body weight from baseline to week 42 of up to 10.2% vs 1.4% for placebo
- Gastrointestinal adverse events were generally mild and occurring at rates similar to placebo; at petrelintide's maximally effective dose, there were no cases of vomiting and no treatment discontinuations due to gastrointestinal adverse events.
- Petrelintide was associated with meaningful improvements in key cardiometabolic risk factors, with reductions in waist circumference of up to 10.8 cm (versus 4.3 cm with placebo), up to 41% reductions in high-sensitivity C-reactive protein (versus 6% with placebo), and reductions of triglycerides of up to 21% (vs 9% with placebo), along with a mean reduction in pulse rate of up to 2.9 beats per minute (bpm) versus a mean increase of 0.3 bpm with placebo.
Petrelintide is being evaluated for chronic weight management in three global Phase 3 registrational trials. For more information about the Phase 3 program, refer to Zealand Pharma Press Release no. 17 / 2026.
About ZUPREME-1
ZUPREME-1 was a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial (ClinicalTrials.gov ID: NCT06662539). The trial compared 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 included a screening period, a dose escalation period of up to 16 weeks with dose escalation every fourth week, followed by a maintenance period until week 42, and a safety follow-up period after treatment was completed until week 51. ZUPREME-1 enrolled 493 participants across 32 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.
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 peptides1. 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 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 monotherapy and a Phase 2 trial evaluating the combination of petrelintide and enicepatide 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.
Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.
Contacts
Eric Rojas (Investors)
Vice President, Head of Investor Relations
erojas@zealandpharma.com
Neshat Anis Ahmadi (Investors)
Investor Relations Manager
neahmadi@zealandpharma.com
Rachel James-Owens (Media)
Vice President, Corporate Communications and Media Relations
rjamesowens@zealandpharma.com
Andreas Hylleberg (Media)
Director, External Communications
Zealand Pharma
ahylleberg@zealandpharma.com
Amber Fennell, Jessica Hodgson, and Sean Leous (Media)
ICR Healthcare
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
