Lixisenatide may slow disease progression, early data show

The Phase 2 trial LixiPark is testing the diabetes therapy in Parkinson's patients

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by Andrea Lobo |

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Early results from a Phase 2 clinical trial testing lixisenatide, a medication used to treat diabetes, in people with Parkinson’s disease, indicate the treatment may slow the progression of motor symptoms.

The LixiPark (NCT03439943) trial is evaluating lixisenatide’s effectiveness as add-on therapy in 156 people with early Parkinson’s during one year, compared to a placebo.

The preliminary trial results were presented earlier this week at the annual congress of the International Parkinson and Movement Disorder Society, in Copenhagen, Denmark.

A full analysis of the trial data is expected to be published in the beginning of 2024.

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“The initial results are very encouraging and provide further evidence that this class of diabetes drugs is doing something interesting in Parkinson’s,” Simon Stott, director of research at Cure Parkinson’s, a co-funder of the trial, said in a press release.

Lixisenatide is a glucagon-like peptide 1 receptor (GLP-1R) agonist approved to treat type 2 diabetes, a condition in which blood sugar levels are too high. It works by mimicking the action of glucagon-like peptide 1, a gut hormone produced in response to food intake to regulate blood sugar levels.

According to Cure Parkinson’s, several studies have shown that some GLP-1R agonists have beneficial effects in the brain. In particular, they may improve neurogenesis — the process by which new neurons are formed — and energy function, and also may provide a protective and supportive effect.

Moreover, previous assessments have indicated that people treated for their diabetes with certain GLP-1R agonists might have a reduced risk of developing Parkinson’s disease.

Lixisenatide became a priority

Lixisenatide was prioritized for clinical testing by the international Linked Clinical Trials (iLCT) initiative launched by Cure Parkinson’s, aiming to identify treatments that might slow, stop, or reverse Parkinson’s disease.

The program focuses mainly on therapies used or being developed for other conditions, offering the opportunity to find new treatments faster and at lower costs.

LixiPark is led by Olivier Rascol, MD, PhD, at the University Hospital of Toulouse, and Wassilios Meissner, MD, PhD, at the University Hospital of Bordeaux. It involves 21 research centers across the NS-Park network in France.

The study is sponsored by the Toulouse University Hospital, and co-funded by Cure Parkinson’s, the Van Andel Institute (VAI) in the U.S. — a collaborator in the iLCT program — and the French Ministry of Health. The medication and placebo are supported by the pharmaceutical company Sanofi.

“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,” Stott said.

The organization is working with the LixiPark principal investigators to plan a Phase 3 clinical trial testing lixisenatide as a treatment for Parkinson’s.

Exenatide also in clinical trials

These preliminary results represent the second clinical trial of a GLP-1R agonist with positive results in people with Parkinson’s. A previous Phase 2 trial suggested that treatment with exenatide, another GLP-1R agonist, for one year may slow Parkinson’s disease progression, according to Cure Parkinson’s.

There is currently a large Phase 3 Exenatide-PD3 (NCT04232969) clinical trial evaluating the two-year safety and efficiency of exenatide, compared to a placebo, in people with Parkinson’s disease.

So far, no GLP-1R agonist is approved to treat Parkinson’s disease, and more trials are being conducted before the drug can be reviewed by regulatory authorities.