DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04305002

UnknownPhase 2

Exenatide Treatment in Parkinson's Disease

Effect of Exenatide on Disease Progression in Early Parkinson's Disease

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

60

actual

Study population

Parkinson's disease

Key I/E criterion

—

Primary endpoint

•FDG-PET network analysis

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 IDNCT04305002
Org study IDExPD-ESR-18-13512

Timeline

Milestones

Study start2020-01-21actual
Study first posted2020-03-12actual
Last update posted2022-09-13actual
Primary completion2023-10-10estimated
Study completion2023-10-10estimated

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age25 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of clinically probable Parkinson's disease according to the MDS clinical diagnostic criteria for PD
•Males or Females
•Hoehn and Yahr stage ≤ 2 in the ON medication state. This implies that all patients will be mobile without assistance during their best "ON" medication periods.
•Patients are on levodopa treatment.
•No need for extended treatment adjustment, no significant motor fluctuations during the last year.
•All patients will be ≥25 and ≤80 years of age
•Ability to self-administer, or to arrange carer administration of the trial drug.
•Signed informed consent to participate in the trial.

Exclusion criteria

•Atypical or other causes of parkinsonism. Patients with suspected Multiple System Atrophy, Progressive Supranuclear Palsy, drug-induced parkinsonism, vascular parkinsonism, dystonic or essential tremor will not be included in the trial.
•Prior intra-cerebral surgical intervention for Parkinson's disease. Patients who have previously undergone Deep Brain Stimulation, intra-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
•Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.
•Previous exposure to Exenatide.
•Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition.
•Patients with body mass index below 18.5. Exenatide causes weight loss, and individuals with already low BMI will not be eligible.
•Patients with diabetes mellitus type 1.
•Patients with prediabetes (HbA1c at screening 42-47 mmol/mol), or T2DM (known diagnosis, ongoing antidiabetic treatment or HbA1c > 47 mmol-mol and fasting plasma glucose > 7.0 mmol/L at screening).
•History of pancreatitis. Baseline serum amylase value should be within the laboratory normal range +/- 20 percent.
•Severe gastrointestinal disease including gastroparesis.
•History of alcoholism.
•History of severe cardiac disease.
•History of pancreas cancer.
•History or suspicion of thyroid cancer. Undiagnosed neck lump, hoarse voice, or difficulty swallowing not attributable to PD.
•Personal or family history of medullary thyroid cancer.
•Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome.
•End stage renal disease or creatinine clearance < 50 ml/min.
•Hyperlipidaemia. A lipid profile will be tested at the screening visit. Cholesterol or Triglyceride levels greater than 2 x the upper limit of normal will raise suspicion of a familial or acquired hyperlipidaemia and will prompt referral to a relevant specialist for investigation and treatment.
•Concurrent treatment with warfarin.
•Concurrent severe depression, defined as MADRS score 16.
•Concurrent dementia, defined as Mini-Mental State Examination (MMSE) < 22.
•Pregnancy and Breastfeeding.
•There are no safety data regarding Exenatide use in pregnancy. Women of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test, and will be asked at each visit to confirm regular use of an effective method of contraception. Those who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and until the end of the relevant systemic exposure period (i.e. 10 weeks after the last dose of study drug) will not be eligible. The following birth control methods are considered to be acceptable: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.
•Known hypersensitivity or allergy or intolerance to GLP-1.
•Known hypersensitivity to Exenatide or any of its excipients.
•Potential participants who lack the capacity to give informed consent
•Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate in the trial.

Endpoints (20)

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

Other clinical outcomes
11
Patient-reported / QoL
5
Safety / tolerability / PK
3
Other (unclassified)
1

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

PDQ-39 mobility subscore

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

Non-Motor Symptoms Questionnaire (NMSQuest)

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

PDQ-39 subscores (except for mobility)

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

Epworth Sleepiness Scale (ESS)

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

MADRS

Time frame:6, 12 and 18 months

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Frequency and severity of Adverse Events

Time frame:21 months

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Exenatide-concentration csf

Time frame:Baseline, 9 and 21 months

concentration, descriptive

Secondary/protocol endpoint

Exenatide levels in serum

Time frame:Baseline, 9, 18 and 21 months

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

11 endpoints
Secondary/protocol endpoint

The sum score of MDS-UPDRS part 3 in ON and OFF-medication state

Time frame:18 and 21 months

change from baseline, improvement

Secondary/protocol endpoint

MDS-UPDRS part 2

Time frame:9, 18 and 21 months

descriptive, improvement

Secondary/protocol endpoint

MDS-UPDRS part 4

Time frame:9, 18 and 21 months

descriptive, improvement

Secondary/protocol endpoint

Hoehn and Yahr

Time frame:18 and 21 months

descriptive

Secondary/protocol endpoint/low confidence

Accelerometer (intensity of physical activity)

Time frame:18 and 21 months

descriptive

Secondary/protocol endpoint/low confidence

Accelerometer (steps per day)

Time frame:18 and 21 months

descriptive

Secondary/protocol endpoint

Accelerometer (time of inactivity per day)

Time frame:9, 18 and 21 months

descriptive

Secondary/protocol endpoint

Levodopa equivalent daily dose (LEDD)

Time frame:Every 3 months

descriptive

Secondary/protocol endpoint

MDS-UPDRS part 1

Time frame:18 and 21 months

change from baseline, improvement

Secondary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:21 months

change from baseline, improvement

Secondary/protocol endpoint

Brief Smell Identification Test (B-SIT)

Time frame:18 months

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

FDG-PET network analysis

Time frame:21 months

descriptive

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.