DelfaGLP-1 Atlas

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UnknownPhase 2

Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study

An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease.

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

40

estimated

Study population

Parkinson's disease

Key I/E criterion

—

Primary endpoint

•Respect of their UPDRS-off-medication motor subscore

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01174810
Org study ID09/0391
Secondary ID2009-018137-37

Timeline

Milestones

Study first posted2010-08-04estimated
Last update posted2012-03-23estimated
Study start2010-07 (month precision)
Primary completion2013-03estimated (month precision)
Study completion2013-03estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age45 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Idiopathic Parkinson's disease of moderate severity- equivalent to Hoehn/ Yahr stage 2 to 2.5 (Bilateral symptoms but still physically independent).

Male or female. Female patients to be post menopausal (defined as 12 months of spontaneous amenorrhoea or 6 months spontaneous amenorrhoea with FSH levels greater than 40mIU/ml), surgically sterilised (post hysterectomy and/or oophorectomy). Male patients with female partners that have child bearing potential must use adequate contraception (condoms +/-spermicidal gel/foam) throughout the duration of the trial period.

•Age 45-70 years
•Disease onset after age 40 years
•Disease duration > 5 years
•On L-dopa treatment. Patient must be on oral L-dopa treatment - with or without dopamine agonist including Apomorphine, MAO-B inhibitor, COMT inhibitor, Amantadine, Beta blocker, anticholinergic treatment History of wearing off phenomena- duration of action of single dose of L-dopa < 6 hours Stable PD medication for preceding 3 months- i.e. no change in medication type or dose.
•UPDRS motor off medication score >15
•L-dopa responsiveness. Defined as >33% improvement in UPDRS motor off medication score following L-dopa challenge
•Able to give informed consent
•Able to comply with trial protocol and willing to attend necessary clinic visits off medication.

Exclusion criteria

•Diagnosis or suspicion of other cause for parkinsonism including Vascular parkinsonism, post traumatic parkinsonism, drug or toxin induced parkinsonism, or other neurodegenerative condition including Multiple System Atrophy, Progressive Supranuclear Palsy, Huntington's disease, Wilson's disease, Pantothenate kinase Neurodegeneration (PKAN), Alzheimer's disease, Creutzfeld Jacob disease.
•Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with trial protocol.

Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale.

•Concurrent severe depression defined by a score greater than 16 on the MADRS Exposure to neuroleptic drugs within 6 months prior to baseline assessment Prior intracerebral surgical intervention for Parkinson's disease including Deep Brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant
•Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease, or trial participation within previous 30 days.
•Type 1 Diabetes mellitus
•Type 2 Diabetes mellitus on insulin treatment
•End stage renal disease or severely impaired renal function with creatinine clearance <30ml/min
•History of severe cardiac disease (Angina, Myocardial infarction or cardiac surgery in preceding 2 years)
•History of pancreatitis
•History of alcoholism
•Severe gastrointestinal disease including gastroparesis
•Ongoing treatment with sulphonylurea
•Females that are pregnant or breast feeding or of child bearing potential.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
1
Other clinical outcomes
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse event profile among patients treated with Exenatide compared with matched PD controls. Change from baseline to 12 months/ 14 months between patients on active treatment and PD controls in respect of list given below

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Change from baseline to 12 months & 14 months between patients on active Exenatide treatment and PD controls in respect of their UPDRS-off-medication motor subscore.

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.