Zealand Pharma A/S (Nasdaq: ZEAL), a pioneer in peptide-based drug development, has shared topline results from its DREAM trial, evaluating the efficacy of low doses of the GLP-1/GLP-2 receptor dual agonist, dapiglutide, in treating obesity. This clinical study marks a significant step forward in understanding the potential of dapiglutide to induce weight loss without lifestyle changes, such as diet or exercise.
Significant Weight Loss Achieved in 12-Week Trial Period
The DREAM trial, conducted over 12 weeks, tested dapiglutide doses of 4 mg and 6 mg. Results showed a mean weight loss of 2.9% and 4.3% at these doses, respectively, compared to a 2.2% weight loss with a placebo. These findings, although preliminary, suggest dapiglutide’s promise as a significant aid in weight management.
Dapiglutide’s Tolerability and Future Trials
“Dapiglutide was well-tolerated, with a safety profile that compares favorably to other incretin-based therapies, often associated with gastrointestinal side effects like reduced appetite and nausea,” reported David Kendall, MD, Chief Medical Officer of Zealand Pharma. The trial also noted that the treatment emergent adverse events were fewer and did not lead to any discontinuation of the therapy, underscoring dapiglutide’s manageable safety profile.
Upcoming Developments
Encouraged by these results, Zealand Pharma is already proceeding with a 13-week Phase 1b trial that involves higher doses of dapiglutide up to 13 mg, aiming to explore the upper limits of its therapeutic range. “Based on the tolerability profile observed to date, we are optimistic about the potential of even higher doses,” said Dr. Kendall. This trial is part of Zealand’s ongoing commitment to expanding the possibilities of peptide-based treatments in weight management.
Broad Implications for Obesity Treatment
The DREAM trial is pivotal not only for its immediate findings but also for its contribution to the broader understanding of dual agonist therapies in obesity management. Zealand plans to present more detailed results, including effects on cardiovascular risk and systemic inflammatory markers, at future scientific meetings.
Dapiglutide, a novel peptide designed for sustained action, targets both the GLP-1 and GLP-2 receptors, promising not just weight loss but also improvements in conditions associated with low-grade inflammation due to enhanced intestinal barrier function. This dual approach could revolutionize treatment paradigms for patients struggling with obesity and its related comorbidities.
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