Zealand Pharma announces positive Phase 2 results for petrelintide, an amylin analog with potential to redefine the weight management experience for people living with overweight and obesity
2026-03-05 19:45:00
Company announcement – No. 3 / 2026
Zealand Pharma announces positive Phase 2 results for petrelintide, an amylin analog with potential to redefine the weight management experience for people living with overweight and obesity
- Petrelintide achieved up to 10.7% mean body weight reduction at week 42 (versus 1.7% with placebo) and demonstrated placebo-like tolerability
- At the maximally effective dose, there were no cases of vomiting and no treatment discontinuations due to gastrointestinal adverse events
- The data reinforce further development of petrelintide in chronic weight management as monotherapy and as a combination partner
- Zealand Pharma will host a conference call today at 8:30 PM CET / 2:30 PM ET
Copenhagen, Denmark, March 5, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced positive topline results from the Phase 2 ZUPREME-1 dose-finding trial evaluating investigational petrelintide versus placebo in 493 people living with overweight and obesity (mean baseline BMI of 37 kg/m2; 53% females) for effects on body weight, safety, and tolerability. The trial met its primary endpoint, demonstrating that once-weekly subcutaneous injections of petrelintide (dose-escalated every fourth week) resulted in statistically significant and clinically meaningful reductions in body weight from baseline after 28 weeks in all five treatment arms compared to placebo.
Body weight reduction was sustained through week 42, with participants achieving up to 10.7% mean reduction from baseline using the efficacy estimand, compared to 1.7% with placebo (p-value <0.001). In the petrelintide treatment arm that achieved the greatest body weight reduction, 98% of trial participants successfully escalated to the targeted maintenance dose, underscoring strong adherence to dose escalation and a highly tolerable treatment approach. Accordingly, body weight reduction using the treatment regimen estimand was largely consistent with the efficacy estimand. Notably, female participants lost considerably more weight than male participants in this trial.
Adam Steensberg, President and Chief Executive Officer, of Zealand Pharma, said,
“Petrelintide has the potential to redefine weight management. Its placebo-like tolerability exceeds our expectations and, combined with double-digit weight reduction, sets a new standard. Key to unlocking the value of the obesity market and delivering improved health outcomes is a treatment patients can stay on. These results bring us closer to giving people the obesity treatments that fit the lives they actually want to live.”
Petrelintide demonstrated a favorable tolerability profile comparable to placebo. The treatment discontinuation rate due to adverse events (AEs) was 4.8% with petrelintide in the maximally effective treatment arm versus 4.9% with placebo. The most frequently reported AEs were gastrointestinal-related, the vast majority of which were mild. The proportion of participants across all petrelintide treatment arms who experienced vomiting was lower than that observed with placebo, with no vomiting in the maximally effective dose arm, whereas the rates of diarrhea and constipation were consistent with those seen with placebo and remained in the single-digit range. Nausea was less common than in the prior 16-week Phase 1b trial of petrelintide, which used dose escalation every second week, and the vast majority was mild. Almost no events of nausea were reported after participants reached their targeted maintenance dose of petrelintide.
No unexpected safety signals were observed with petrelintide treatment, including for alopecia, fatigue, and neuropsychiatric adverse events (e.g., headache and depression). The proportion of petrelintide-treated participants experiencing injection site reactions was very low and consistent with placebo. Trial withdrawal due to any reason was 8.4% across petrelintide treatment arms compared to 13.6% with placebo.
David Kendall, MD, Chief Medical Officer of Zealand Pharma, said,
“ We are very excited with the results of this Phase 2 trial of petrelintide, demonstrating double-digit body weight reduction with an exceptional tolerability profile and rates of GI adverse events comparable to placebo. These data reinforce petrelintide’s potential to establish a new class of therapy and redefine the weight management experience for people living with overweight and obesity. We now look forward to rapidly advancing the program towards expected Phase 3 initiation later this year.”
The final trial results, including a nine-week safety follow-up period, are expected to be presented at an upcoming scientific conference in 2026. The ZUPREME-1 data will inform the optimal Phase 3 designs and settings to evaluate petrelintide. Topline results from the second Phase 2 trial with petrelintide monotherapy, ZUPREME-2, which is evaluating petrelintide versus placebo in people living with overweight or obesity and type 2 diabetes, are expected in the second half of 2026 as well. A Phase 2 trial exploring the combination of petrelintide and CT-388 will be initiated in the first half of 2026.
In 2025, Roche and Zealand Pharma entered into an exclusive collaboration and licensing agreement to co-develop and co-commercialise petrelintide for people living with overweight and obesity.
