Zealand Pharma A/S is advancing its obesity drug candidate, dapiglutide, into a Phase 2b trial following positive results from a Phase 1b study. The drug, a GLP-1/GLP-2 receptor dual agonist, demonstrated significant weight loss in participants after 13 weeks of treatment, positioning it as a potential competitor to Novo Nordisk's Wegovy and Eli Lilly's Zepbound.
Phase 1b Trial Results
The Phase 1b trial revealed that participants receiving dapiglutide experienced a mean weight loss of up to 6.2% after 13 weekly doses. When adjusted for the weight gain observed in the placebo group, the mean weight loss reached 8.3%. The trial assessed the safety, tolerability, and clinical effects of dapiglutide at doses up to 13 mg.
David Kendall, MD, Chief Medical Officer of Zealand Pharma, stated, "We are both excited and very encouraged by these data from this short-term trial showing substantial and clinically relevant reductions in body weight." He further noted the potential for dapiglutide to have a differentiated profile due to its dual agonist effects, which could positively impact inflammation.
Safety and Tolerability
Dapiglutide was found to be safe and well-tolerated in the Phase 1b trial. The most common treatment-emergent adverse events (TEAEs) were gastrointestinal (GI) in nature, including nausea and vomiting, consistent with other incretin-based therapies. Only two participants discontinued treatment due to GI-related adverse events. Injection site reactions were minimal and mild. Anti-drug antibodies were observed in 14.3% of participants.
Ongoing and Future Development
Zealand Pharma is currently evaluating higher doses of dapiglutide, up to 26 mg, over a 28-week treatment period in Part 2 of the Phase 1b trial, with topline results expected in the first half of 2025. The company plans to initiate a Phase 2b trial in people living with overweight and obesity in the first half of 2025. The company also intends to explore dapiglutide's potential in treating select obesity-related comorbidities.
The Phase 1b trial was a randomized, double-blind, placebo-controlled study involving participants with a BMI between 27.0 and 39.9 kg/m2. Part 1 included 54 participants across three dose cohorts, while Part 2 includes 30 participants in one dose cohort. No lifestyle modifications, such as diet or exercise, were included in the trial.
About Dapiglutide
Dapiglutide is a long-acting, dual GLP-1/GLP-2 receptor agonist designed to leverage the weight loss effects of GLP-1 while addressing comorbidities associated with low-grade inflammation through improved intestinal barrier function via GLP-2 activation.
