Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease

NCT03439943 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the medication lixisenatide can help people with Parkinson's disease by measuring changes in their movement symptoms over a 12-month period.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 156 people

Who can join Ages 40–75 · all sexes

Timeline Started 2018-06 · est. completion 2021-04

Where 20 sites · France

What this study is testing ClinicalTrials.gov NCT03439943 ↗

Description as written by the study sponsor.

The main objective of the study is to evaluate the effect of lixisenatide (20 μg/d), versus placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the progression of motor disability in patients with early PD in order to assess its potential "disease-modifying" effect.

Treatments tested

Lixisenatide also known as injection drug Drug

Patients randomized in the Lixisenatide group will receive 10μg/day for 14 days and then 20μg/day administered by once-daily subcutaneous injections during 12 months. If patients are unable to tolerable the dose of 20μg/day, this dose can be reduced to 10μg/day
placebo also known as placebo injection Drug

Patients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection).

Main thing measured	Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale)
Sponsor	University Hospital, Toulouse
Conditions studied	Parkinson Disease
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03439943 ↗