GLP-1 receptor agonists have previously been evaluated as treatments for type 2 diabetes or obesity, and other work has also suggested that these drugs are neuroprotective in mouse models of PD. To investigate whether these findings extended into humans, the authors conducted a phase 2 clinical trial of 156 patients with PD from 21 clinics across France, with the primary goal of seeing whether lixisenatide could affect patients’ scores on part III of a survey called the MDS-UPDRS, which measures PD-associated motor symptoms. All patients were in the early stages of disease onset and had only been diagnosed with PD within three years of the trial. Patients were evenly split into two groups who received a daily injection of either a placebo or 20 µg of lixisenatide for 12 months, alongside their current medication regime (for example, levodopa).
Participants were brought into the clinic at 1–3-month intervals after the start of the trial, so that the authors could monitor their health. In part, this meant the authors could watch out for the development of adverse side effects and adjust the patients’ treatment regimens. As described by the study’s corresponding author, Olivier Rascol, “we had about 40% of our patients [28/75] receiving the drug [lixisenatide] who complained of nausea, which was expected. And we anticipated that some of the patients would have this kind of problem; rather than dropping out for side effects, we allowed them to down-titrate to 10 µg a day, half the dose.” Likewise, levodopa dosing was adjusted on a case-by-case basis, although Rascol highlights that this did not differ between the placebo and lixisenatide arms (~4.4 mg difference in levodopa dosing by the end of the study).
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