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Could a diabetes injection help early Parkinson's patients?

NCT ID NCT03439943

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

156 people

The number who actually took part.

Started

Jun 2018

Finished

Apr 2021

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • CHU Toulouse

    Toulouse, 31000, France

  • Creteil- Henri Mondor Hospital

    Créteil, France

  • Pitié Salpêtrière Hospital

    Paris, France

  • University Hospital of Amiens

    Amiens, France

  • University Hospital of Besancon

    Besançon, France

  • University Hospital of Bordeaux

    Bordeaux, France

  • University Hospital of Caen

    Caen, France

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand, France

  • University Hospital of Lille

    Lille, France

  • University Hospital of Limoges

    Limoges, France

  • University Hospital of Lyon

    Lyon, France

  • University Hospital of Marseille

    Marseille, France

  • University Hospital of Montpellier

    Montpellier, France

  • University Hospital of Nancy

    Nancy, France

  • University Hospital of Nantes

    Nantes, France

  • University Hospital of Nice

    Nice, France

  • University Hospital of Poitiers

    Poitiers, France

  • University Hospital of Rennes

    Rennes, France

  • University Hospital of Rouen

    Rouen, France

  • University Hospital of Strasbourg

    Strasbourg, France

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