Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients with PD according to UKPDSBB criteria (male or female).
Patient with a Hoehn and Yahr Stage <3 in the ON condition.
Patients aged from 40 to 75 years old.
Early-stage PD patients: diagnosis of PD for less than 3 years, without dyskinesia and motor fluctuations.
Patients treated with an "optimized" stable dopaminergic medication regimen (dopamine agonist and/or L-dopa and/or MAOB inhibitor) for at least 1 month before baseline.
Patients expected to remain on stable doses of antiparkinsonian medications for at least the first 6 months of the study and preferably for the 12 months of follow-up.
Patients (or caregiver) able to self-administer lixisenatide injection.
Patients with health insurance.
Patients who signed the written informed consent form.

Exclusion Criteria:

Patients suffering from other parkinsonian syndromes other than PD.
Patients expected not to be able to remain on stable doses of symptomatic antiparkinsonian medications for at least 6-month.
Patients with a Body Mass Index < 18.5
Patients suffering from type 1 or type 2 diabetes.
Malnutrition as assessed clinically by the investigator or any sub-investigator and by Mini Nutritional Assessment Short Form (MNA-SF) score <12 (the judgement of the investigator prevails over questionnaire scores).
Weight change of more than 5 kg in body weight during the last 3 months prior to screening.
Known history of drug or alcohol abuse within 6 months prior to the time of screening.
Patients with hyperthyroidism or uncontrolled hypothyroidism. Note: Patients diagnosed with hypothyroidism need to be on a stable thyroid replacement therapy for at least 6 weeks.
Patients with severe depression according to DSM criteria.
Patients with cognitive impairment (MoCA score <26).
Severe gastrointestinal disease (e.g. gastroparesis).
Patients previously exposed to a GLP-1 agonist.
Patients with severely impaired renal function (estimated creatinine clearance <30ml/min).
Patients with a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or ongoing symptomatic gallbladder disease.
Patients with any clinically significant ECG abnormality.
Laboratory findings at the time of screening:

Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range ALT or AST: >3 times ULN Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome) Calcitonin: >20 pg/mL (5.9 pmol/L) Hemoglobin: <11 g/dL (male/female) and/or neutrophils <1,500/mm3 and/or platelets <100,000/mm3 Triglyceride (TG): >600 mg/dL (6.78 mmol/L). History of unexplained pancreatitis, chronic pancreatitis or pancreatectomy.

Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes).
Hyperlipidemia.
Females who are pregnant, breast feeding or of child bearing age without effective contraception.
Patients treated per os in the evening by drugs requiring a rapid action (at the discretion of the investigator).
Participants who lack the capacity to give informed consent.
Any medical or psychiatric condition which may compromise participation in the study or the safety, at the discretion of the investigator.
Known abnormality on CT or MRI brain imaging that is considered likely to compromise compliance with any aspect of the trial.
Prior intra-cerebral surgical intervention for PD.
Participant under legal guardianship or incapacitation.
Patients who are participating or have participated in another interventional clinical trial within 30 days prior to baseline.
Previous enrolment in the present trial.
Allergic reaction to the active substance or to any of the excipients of lixisenatide