en.Wedoany.com Reported - Zealand Pharma A/S (Zealand Pharma) announced new data from the Phase 2 ZUPREME-1 trial of its amylin analog petrelintide, presented at the 2026 American Diabetes Association (ADA) Scientific Sessions. The data showed clinically meaningful double-digit weight loss over 42 weeks, with a safety profile comparable to the placebo group and a low rate of treatment discontinuation due to gastrointestinal adverse events.
This 42-week, double-blind, parallel-group, dose-finding trial enrolled 485 adult participants (53% female; mean age 47 years, body mass index 36.7 kg/m2; mean body weight 107.1 kg). Participants were randomized in a 5:1 ratio to receive once-weekly subcutaneous injections of five different doses of petrelintide or placebo. The trial met its primary endpoint, with all five treatment groups showing a significantly greater percentage reduction in body weight from baseline after 28 weeks compared to placebo.
Secondary and exploratory endpoint data showed that at 42 weeks, the mean weight reduction in the petrelintide group reached up to 10.7%, compared to 1.7% in the placebo group (all comparisons were statistically significant). Between 88% and 98% of participants successfully escalated to the target maintenance dose. The majority (over 75%) of gastrointestinal adverse events were mild; nausea was a common symptom, occurring in 19.6% of the petrelintide group and 6.2% of the placebo group. Rates of vomiting (3.0% vs. 6.2%), diarrhea, and constipation were lower in the petrelintide group. Only 1.5% of participants discontinued petrelintide due to gastrointestinal adverse events, and no unexpected safety issues were identified. Additionally, petrelintide treatment was associated with improvements in several cardiometabolic risk factors, including a reduction in waist circumference of 7.9 to 10.8 cm (4.3 cm in the placebo group), a 17% to 41% decrease in high-sensitivity C-reactive protein (hsCRP) (6% in the placebo group), and a 12% to 21% reduction in triglycerides (9% in the placebo group).
David Kendall, Chief Medical Officer of Zealand Pharma, stated that current treatments for overweight and obesity have low real-world persistence, necessitating solutions addressing durability, tolerability, and acceptability. He believes that petrelintide's tolerability profile, combined with meaningful weight loss, positions it as a potential first-line treatment option for future chronic weight management. W. Timothy Garvey, Professor of Nutritional Sciences at the University of Alabama at Birmingham, also noted that individuals with overweight and obesity require treatment regimens that can be sustained long-term and feature a tolerability profile supporting adherence.
In 2025, Roche entered into an exclusive collaboration and license agreement with Zealand Pharma to co-develop and commercialize petrelintide. In April 2026, the two companies announced formal support for advancing the drug into Phase 3 trials, with initiation planned for the second half of 2026. Full results from the ZUPREME-1 trial are scheduled to be released later this year.
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