Zealand Pharma reveals topline results from DREAM trial on low-dose dapiglutide
Zealand Pharma, a biotechnology company specializing in peptide-based therapies, announced promising topline results from the investigator-led DREAM trial. This trial evaluated the weight loss potential and mechanistic effects of low doses of dapiglutide, a GLP-1/GLP-2 receptor dual agonist, over a 12-week treatment period.
Trial Overview
The DREAM trial, registered under ClinicalTrials.gov ID: NCT05788601, was a randomized, placebo-controlled, single-center study involving 54 obese participants (median BMI 34.8 kg/m²). The trial aimed to assess the weight loss effects of dapiglutide and gain insights into its mechanisms. Participants received weekly subcutaneous injections of either 4 mg or 6 mg of dapiglutide, or a placebo. Those on 4 mg started at 2 mg and increased to 4 mg after three weeks. Similarly, the 6 mg group began at 2 mg, increased to 4 mg after three weeks, and reached 6 mg after six weeks.
Key Findings
The trial revealed a mean weight loss of 2.9% and 4.3% at 12 weeks for the 4 mg and 6 mg dapiglutide doses, respectively, compared to a 2.2% loss in the placebo group. Despite the trial's small size and short duration, these results were encouraging. David Kendall, MD, Chief Medical Officer of Zealand Pharma, stated, "The weight reduction seen with low doses of dapiglutide aligns with earlier outcomes from other incretin-based treatments."
Safety and Tolerability
Dapiglutide was found to be well-tolerated. The most common side effects were gastrointestinal issues like reduced appetite and nausea, which were less frequent than those seen with other incretin-based treatments. Importantly, no adverse events led to treatment discontinuation.
Ongoing and Future Studies
Zealand Pharma is conducting a more extensive 13-week Phase 1b trial (ClinicalTrials.gov ID: NCT06000891) to test higher doses of dapiglutide, up to 13 mg. This trial includes overweight or obese individuals with a BMI ranging from 27.0 to 39.9. Topline results from this study are expected in the latter half of 2024. Based on current tolerability data, the company plans to explore even higher doses in future studies.
Additional Insights
Further detailed results, including cardiovascular risk, systemic inflammatory markers, and gut biopsy data, will be presented at an upcoming scientific meeting. These findings could provide deeper insights into the broader health impacts of dapiglutide.
About Obesity and Inflammation
Obesity is a chronic disease linked to significant morbidity and mortality worldwide. It is often associated with low-grade systemic inflammation, which can lead to comorbidities such as cardiovascular diseases, liver conditions, and neuroinflammation. Dapiglutide aims to address these issues by improving intestinal barrier function, thereby reducing systemic inflammation.
About Dapiglutide
Dapiglutide is a novel, long-acting peptide that targets both GLP-1 and GLP-2 receptors. It has shown dose-dependent weight loss in previous Phase 1 studies, with a mean weight reduction of up to 4.3% over four weeks. The drug also delayed gastric emptying and reduced plasma glucose and insulin levels. Its pharmacokinetics support once-weekly dosing, with a mean half-life of 123-129 hours.
About Zealand Pharma
Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma focuses on developing peptide-based medicines. The company has advanced more than 10 drug candidates into clinical development, with two reaching the market and three in late-stage development. Zealand Pharma collaborates with various pharmaceutical companies for both development and commercial partnerships.
In conclusion, the DREAM trial results highlight the potential of dapiglutide as a promising treatment for obesity, with further studies aimed at exploring higher doses and broader health impacts. The company remains committed to advancing innovative therapies to address global health challenges.
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