Parkinson DiseasePhase 2LixiParkNCT03439943
Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease
A Phase 2 study testing Lixisenatide in people with Parkinson Disease, run by University Hospital, Toulouse at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Lixisenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 20 sitesFrance
- Study dates
- 13 Jun 2018to 15 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Patients (or caregiver) able to self-administer lixisenatide injection.
- Patients with health insurance.
- Patients who signed the written informed consent form.
Who cannot join
- 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.
Show all 29Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
University Hospital of Amiens
Amiens
University Hospital of Besancon
Besançon
University Hospital of Bordeaux
Bordeaux
University Hospital of Caen
Caen
University Hospital of Clermont-Ferrand
Clermont-Ferrand
Creteil- Henri Mondor Hospital
Créteil
University Hospital of Lille
Lille
University Hospital of Limoges
Limoges
University Hospital of Lyon
Lyon
University Hospital of Marseille
Marseille
University Hospital of Montpellier
Montpellier
University Hospital of Nancy
Nancy
University Hospital of Nantes
Nantes
University Hospital of Nice
Nice
Pitié Salpêtrière Hospital
Paris
University Hospital of Poitiers
Poitiers
University Hospital of Rennes
Rennes
University Hospital of Rouen
Rouen
University Hospital of Strasbourg
Strasbourg
CHU Toulouse
Toulouse, 31000
About this study
Official title: Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
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.
Read the detailed description
This study will be a French, multicenter parallel groups, 2-arm, randomized, placebo-controlled, double-blind, proof-of-concept (POC) phase II trial evaluating the effect of lixisenatide, in patients with early PD.
The treatment period will be followed by a wash-out period of 2 months.
JUSTIFICATION/CONTEXT Parkinson's disease (PD) is a common neurodegenerative disease. Currently available symptomatic treatments allow improving motor and to a lesser extent non-motor function in PD patients.
None of these treatments can slow down the underlining disease process and the relentless progression of motor and non-motor disability.
Several mechanisms including the aggregation of misfolded alphasynuclein, mitochondrial dysfunction, oxidative stress and neuroinflammation have been related to the pathogenesis of PD. Recent evidence further suggests the implication of cerebral insulin resistance in the neurodegenerative process, while glucagon-like peptide 1 receptor (GLP1-R) agonists that are approved for the treatment of type 2 diabetes have neuroprotective properties in animal models of PD (Aviles-Olmos et al., 2013a). Moreover, the results of a recent clinical pilot trial suggest that treatment with the GLP-1R agonist exenatide for 12 months improves motor function in patients with moderate PD . GLP1-R are widely expressed in the central nervous system and GLP1-R agonists such as liraglutide, lixisenatide and exenatide have measurable brain concentrations, which makes them suitable for treating brain disorders.
Lixisenatide is a well-tolerated GLP-1R agonist that can be administered once-daily (subcutaneous injection). It has demonstrated positive effects on learning and memory through an increase of hippocampal neurogenesis in preclinical models of obesity/diabetes. Furthermore, lixisenatide increases neurogenesis and decreases microglial activation in rodent models of Alzheimer's disease (APPswe/PS1ΔE9 mice and Aβ25-35 rats) (. At the same dose, lixisenatide showed higher effectiveness at activating brain GLP-1R than liraglutide and exenatide, and showed more effective neuroprotection in a variety of in-vitro models of neurodegeneration (WO2013/030409A1).
Thus, this randomized, double-blind, clinical trial now aim to evaluate the effects of lixisenatide, versus placebo, on both motor and non-motor PD symptoms in patients at an early stage of PD.
This study will involve centers of the French national Parkinson's disease and movement disorders research network (Ns-Park network).
- Conditions
- Parkinson Disease
- Being tested
- Lixisenatide, placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LixisenatideDrug
Also called injection 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
placeboDrug
Also called placebo injection
Patients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection).
| Study group | Role | What they receive |
|---|---|---|
| Lixisenatide | Experimental | Lixisenatide (10μg/d for 14 days and then 20μg/d): once daily subcutaneous Receives: Drug: Lixisenatide |
| Placebo | Placebo comparator | Placebo: once daily subcutaneous injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale)
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.
The primary endpoint of this study is the change from baseline to end-point (M12) in the MDS-UPDRS III motor examination score, evaluated in the best ON condition in patients with early Parkinson's Disease.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start13 Jun 2018
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Cure Parkinson's, Réseau NS-Park, EUCLID Clinical Trial Platform, Sanofi
- Responsible party
- Sponsor
- Investigators
- Olivier. RASCOL, MD, PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439943
- Sponsor's protocol ID
- RC31/16/8912
- Acronym
- LixiPark
- Status last verified
- Jun 2023
- First submitted
- 13 Feb 2018
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38598572
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03439943
- Acronym / sponsor ID
- LixiPark / RC31/16/8912
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Cure Parkinson's, Réseau NS-Park, EUCLID Clinical Trial Platform, Sanofi
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a French, multicenter parallel groups, 2-arm, randomized, placebo-controlled, double-blind, proof-of-concept (POC) phase II trial evaluating the effect of lixisenatide, in patients with early PD.
The treatment period will be followed by a wash-out period of 2 months.
JUSTIFICATION/CONTEXT Parkinson's disease (PD) is a common neurodegenerative disease. Currently available symptomatic treatments allow improving motor and to a lesser extent non-motor function in PD patients.
None of these treatments can slow down the underlining disease process and the relentless progression of motor and non-motor disability.
Several mechanisms including the aggregation of misfolded alphasynuclein, mitochondrial dysfunction, oxidative stress and neuroinflammation have been related to the pathogenesis of PD. Recent evidence further suggests the implication of cerebral insulin resistance in the neurodegenerative process, while glucagon-like peptide 1 receptor (GLP1-R) agonists that are approved for the treatment of type 2 diabetes have neuroprotective properties in animal models of PD (Aviles-Olmos et al., 2013a). Moreover, the results of a recent clinical pilot trial suggest that treatment with the GLP-1R agonist exenatide for 12 months improves motor function in patients with moderate PD . GLP1-R are widely expressed in the central nervous system and GLP1-R agonists such as liraglutide, lixisenatide and exenatide have measurable brain concentrations, which makes them suitable for treating brain disorders.
Lixisenatide is a well-tolerated GLP-1R agonist that can be administered once-daily (subcutaneous injection). It has demonstrated positive effects on learning and memory through an increase of hippocampal neurogenesis in preclinical models of obesity/diabetes. Furthermore, lixisenatide increases neurogenesis and decreases microglial activation in rodent models of Alzheimer's disease (APPswe/PS1ΔE9 mice and Aβ25-35 rats) (. At the same dose, lixisenatide showed higher effectiveness at activating brain GLP-1R than liraglutide and exenatide, and showed more effective neuroprotection in a variety of in-vitro models of neurodegeneration (WO2013/030409A1).
Thus, this randomized, double-blind, clinical trial now aim to evaluate the effects of lixisenatide, versus placebo, on both motor and non-motor PD symptoms in patients at an early stage of PD.
This study will involve centers of the French national Parkinson's disease and movement disorders research network (Ns-Park network).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixisenatide | Experimental | Drug: LixisenatideLixisenatide (10μg/d for 14 days and then 20μg/d): once daily subcutaneous |
| Placebo | Placebo comparator | Drug: placeboPlacebo: once daily subcutaneous injection |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LixisenatideAlso: injection drugPatients 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 | Drug | Lixisenatide |
| placeboAlso: placebo injectionPatients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection). | Drug | Placebo |
Primary outcome
Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale)
Time frame: 12 month
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. The primary endpoint of this study is the change from baseline to end-point (M12) in the MDS-UPDRS III motor examination score, evaluated in the best ON condition in patients with early Parkinson's Disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 38598572Meissner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier. RASCOL, MD, PHD principal investigator
University Hospital, Toulouse
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lixisenatide in people with Parkinson Disease, run by University Hospital, Toulouse at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to end-point (M12) in the MDS-UPDRS III motor (Movement Disorder Society-Unified Parkinson's disease rating scale) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.