Could a diabetes injection help early Parkinson's patients?
NCT ID NCT03439943
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 2 trial tested whether lixisenatide, a daily injection already used for diabetes, could slow the worsening of motor symptoms in 156 people with early Parkinson's disease. Participants received either the drug or a placebo for 12 months, alongside their usual Parkinson's medications. The study measured changes in movement disability to see if lixisenatide has a disease-modifying effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lixisenatide (a daily injection used for diabetes, repurposed for Parkinson's)
- What this could lead to
- If successful, this could point toward a treatment that slows the worsening of movement problems in early Parkinson's disease.
- What could go wrong
- This is a small, early-stage (Phase 2) proof-of-concept trial, so results may not confirm benefit. The drug can cause nausea and other side effects, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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156 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Apr 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Toulouse
Toulouse, 31000, France
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Creteil- Henri Mondor Hospital
Créteil, France
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Pitié Salpêtrière Hospital
Paris, France
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University Hospital of Amiens
Amiens, France
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University Hospital of Besancon
Besançon, France
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University Hospital of Bordeaux
Bordeaux, France
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University Hospital of Caen
Caen, France
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University Hospital of Clermont-Ferrand
Clermont-Ferrand, France
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University Hospital of Lille
Lille, France
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University Hospital of Limoges
Limoges, France
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University Hospital of Lyon
Lyon, France
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University Hospital of Marseille
Marseille, France
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University Hospital of Montpellier
Montpellier, France
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University Hospital of Nancy
Nancy, France
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University Hospital of Nantes
Nantes, France
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University Hospital of Nice
Nice, France
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University Hospital of Poitiers
Poitiers, France
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University Hospital of Rennes
Rennes, France
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University Hospital of Rouen
Rouen, France
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University Hospital of Strasbourg
Strasbourg, France
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