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

Phase 2 Completed 156 enrolled University Hospital, Toulouse Cure Parkinson's · collab EUCLID Clinical Trial Platform · collab Réseau NS-Park · collab Sanofi · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2018-06-13
Primary completion: 2021-04-15
Completion: 2021-04-15

Outcome

Met primary endpoint

paper difference, 3.08; 95% confidence interval, 0.86 to 5.30; P = 0.007 PMID 38598572 ↗

paper lixisenatide therapy resulted in less progression of motor disability than placebo at 12 months in a phase 2 trial PMID 38598572 ↗

Publications

Results Meissner WG, Remy P, Giordana C, Maltete D, Derkinderen P, Houeto JL, Anheim M, Benatru I, Boraud T, Brefel-Courbon C, Carriere N, Catala H, Colin O, Corvol JC, Damier P, Dellapina E, Devos D, Drapier S, Fabbri M, Ferrier V, Foubert-Samier A, Frismand-Kryloff S, Georget A, Germain C, Grimaldi S, Hardy C, Hopes L, Krystkowiak P, Laurens B, Lefaucheur R, Mariani LL, Marques A, Marse C, Ory-Magne F, Rigalleau V, Salhi H, Saubion A, Stott SRW, Thalamas C, Thiriez C, Tir M, Wyse RK, Benard A, Rascol O; LIXIPARK Study Group. Trial of Lixisenatide in Early Parkinson's Disease. N Engl J Med. 2024 Apr 4;390(13):1176-1185. doi: 10.1056/NEJMoa2312323.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lixisenatide	Peptide	20 ug	Subcutaneous