Preliminary phase 2 trial results of lixisenatide presented
NOTE: This release was originally published by Cure Parkinson’s.
August 28, 2023
Copenhagen, Denmark (August 28, 2023) — A one-year, phase 2 clinical trial of Type 2 diabetes drug lixisenatide has reported positive early results, which indicate that the treatment may slow the progression of motor (or movement) symptoms. Preliminary results of the LixiPark study were presented at the International Parkinson and Movement Disorder Society annual congress in Copenhagen on Monday, August 28, with full results analysis expected to be published in early 2024.
The LixiPark study involved 156 people with Parkinson’s. The trial met its primary endpoint — the efficacy measures that the trial set out to achieve — as “topline” results showed that the progression of motor symptoms in those receiving the lixisenatide treatment slowed, while motor symptoms in participants receiving the placebo continued to progress.
Led by Professors Olivier Rascol and Wassilios Meissner at the University Hospitals of Toulouse and Bordeaux, the trial involved 21 different research centers of the NS-Park network across France. The study, sponsored by the Toulouse University Hospital, was co-funded by Cure Parkinson’s, Van Andel Institute, U.S., and the French Ministry of Health, with drug and placebo support from pharmaceutical company Sanofi.
Lixisenatide was prioritized for clinical testing through Cure Parkinson’s and VAI’s International Linked Clinical Trials (iLCT) program.
Lixisenatide belongs to a group of Type 2 diabetes medicines called glucagon-like peptide 1 receptor agonists (or GLP-1R agonists) that function by mimicking the action of a naturally occurring gut hormone that is produced after eating food. GLP-1R agonists are clinically approved for the treatment of diabetes, and importantly, GLP-1R agonists have demonstrated beneficial actions in the brain.
Related: Learn more about the International Linked Clinical Trials (iLCT) program ➔
Drug trials: The phases explained
These preliminary results are important because they represent the second clinical trial of GLP-1R agonists in people with Parkinson’s to have demonstrated a positive result. The results of a previous small clinical “pilot” trial of another GLP-1R agonist called exenatide suggested that those people with moderate Parkinson’s treated with exenatide for 12 months showed improvement in their motor symptoms. The recent LixiPark study was much larger than the exenatide pilot study and involved 21 research centers across France; the LixiPark study results replicate the earlier exenatide results. There is now a large, multicenter phase 3 clinical trial of exenatide for Parkinson’s being run across the UK, and the topline results are due to be reported in the second half of 2024.
Simon Stott, Ph.D., Director of Research at Cure Parkinson’s, said:
“Cure Parkinson’s is proud to have supported this study. We congratulate the investigators who conducted it, and we thank the participants and their families. The initial results are very encouraging and provide further evidence that this class of diabetes drugs is doing something interesting in Parkinson’s.”
Darren Moore, Ph.D., Chair, Department of Neurodegenerative Science, Van Andel Institute, said:
“These preliminary results are promising, and we look forward to publication of the full results. We are deeply appreciative of the trial participants, without whom this vital work would not have been possible.”
Next steps
While these results show promising potential, it is important to note that there are currently no GLP-1R agonists, including lixisenatide, that are approved for use in Parkinson’s and further testing is required before this drug can be reviewed by regulators for use in Parkinson’s. Cure Parkinson’s is now working closely with the principal investigators of the LixiPark study to plan the next phase in the development of this interesting drug, which is likely to be a phase 3 clinical trial of lixisenatide for Parkinson’s.
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Cure Parkinson’s funds and facilitates curative research across the globe. Our funding and innovation through our International Linked Clinical Trials Programme has enabled the world’s leading Parkinson’s researchers to collaborate in prioritising the next generation of drugs for clinical trial. In 2022, nearly 30% of all drugs that were being tested in clinical trials as possible cures for Parkinson’s had been evaluated by the iLCT Committee.
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Van Andel Institute (VAI) is committed to improving the health and enhancing the lives of current and future generations through cutting-edge biomedical research and innovative educational offerings. Established in Grand Rapids, Michigan, in 1996 by the Van Andel family, VAI is now home to nearly 500 scientists, educators and support staff, who work with a growing number of national and international collaborators to foster discovery. The Institute’s scientists study the origins of cancer, Parkinson’s and other diseases and translate their findings into breakthrough prevention and treatment strategies. Our educators develop inquiry-based approaches for K-12 education to help students and teachers prepare the next generation of problem-solvers, while our Graduate School offers a rigorous, research-intensive Ph.D. program in molecular and cellular biology. Learn more at vai.org.