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Exenatide-PD3
CompletedPhase 3Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
194
actual
Study population
Parkinson's disease
Key I/E criterion
—
Primary endpoint
•Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Diagnosis of Parkinson's disease.
2. Hoehn and Yahr stage ≤2.5 in the ON medication state.
3. Between 25 and 80 years of age.
4. On dopaminergic treatment for at least 4 weeks before enrolment.
5. Ability to self-administer, or to arrange carer administration of trial medication.
6. Documented informed consent to participate.
Exclusion criteria
1. Diagnosis or suspicion of other cause for Parkinsonism.
2. Patients unable to attend the clinic visits in the practically defined OFF medication state.
3. Body mass index <18.5.
4. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
5. Significant cognitive impairment defined by a score <21 on the Montreal Cognitive Assessment.
6. Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9).
7. Prior intra-cerebral surgical intervention for Parkinson's disease.
8. Previous participation in one of the following Parkinson's disease trials (Biogen SPARK trial, Prothena Pasadena trial, Sanofi Genzyme MOVES-PD trial, UDCA-PD UP Study or any other trial still considered to involve a potentially PD modifying agent).
9. Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days
10. Previous exposure to exenatide.
11. Impaired renal function with creatinine clearance <50ml/min.
12. History of pancreatitis.
13. Type 1 or Type 2 diabetes mellitus.
14. Severe gastrointestinal disease (e.g. gastroparesis)
15. Hyperlipidaemia.
16. History or family history of medullary thyroid cancer (MTC).
17. Multiple endocrine neoplasia 2 (MEN2) syndrome.
18. Hypersensitivity to any of exenatide's excipients.
19. Females that are pregnant or breast feeding.
20. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire trial period and up to 3 months after the last dose of trial medication.
21. Participants who lack the capacity to give informed consent
22. Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator's opinion compromises the potential participant's ability to participate.
Endpoints (46)
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
Weight & body composition
1 endpointSafety and tolerability of exenatide as indicated by changes in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
Time frame:96 weeks
BMI, change
change from baseline, descriptive
Glycemic / diabetes
2 endpointsSafety and tolerability of exenatide as indicated by changes in Glucose (mmol/L)
Time frame:96 weeks
Fasting glucose, change
change from baseline, descriptive
LOINC 1558-6
Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L)
Time frame:96 weeks
change from baseline, descriptive
MASH / liver
2 endpointsSafety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L)
Time frame:96 weeks
ALT, change
change from baseline, improvement
LOINC 1742-6
Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L)
Time frame:96 weeks
AST, change
change from baseline, improvement
LOINC 1920-8
Renal / kidney
1 endpointSafety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min)
Time frame:96 weeks
change from baseline, descriptive
Cardiometabolic biomarkers
5 endpointsSafety and tolerability of exenatide as indicated by changes in pulse (bpm)
Time frame:96 weeks
Heart rate, change
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg)
Time frame:96 weeks
change from baseline, improvement
Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L)
Time frame:96 weeks
Fibrinogen, change
change from baseline, improvement
Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL)
Time frame:96 weeks
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL)
Time frame:96 weeks
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Patient-reported / QoL
4 endpointsUnified Dyskinesia Rating Scale (UDysRS)
Time frame:96 weeks
descriptive, improvement
Patient Health Questionnaire-9 (PHQ-9)
Time frame:96 weeks
descriptive, improvement
Parkinson's Disease 39 item Quality of life questionnaire
Time frame:96 weeks
change from baseline, improvement
Non-Motor Symptoms Scale (NMSS)
Time frame:96 weeks
change from baseline, improvement
Safety / tolerability / PK
25 endpointsSafety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L)
Time frame:96 weeks
change from baseline, descriptive
LOINC 789-8
Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
LOINC 6690-2
Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Haematocrit (%)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin)
Time frame:96 weeks
HbA1c, change
change from baseline, descriptive
LOINC 4548-4
Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L)
Time frame:96 weeks
change from baseline, descriptive
Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L)
Time frame:96 weeks
Thyroid event
change from baseline, event
Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L)
Time frame:96 weeks
Thyroid event
change from baseline, event
Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events
Time frame:96 weeks
Treatment-emergent AEs (any)
descriptive, event
Other clinical outcomes
6 endpointsMovement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time frame:96 weeks
change from baseline, improvement
Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.
Time frame:96 weeks
change from baseline, improvement
Timed Walk assessment ON and OFF medication
Time frame:96 weeks
descriptive
Montreal Cognitive Assessment
Time frame:96 weeks
descriptive, improvement
Levodopa Equivalent Dose
Time frame:96 weeks
descriptive
3 day Hauser diary of Parkinson's Disease State
Time frame:96 weeks
descriptive
Publications (3)
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
- Clinical trials (London, England)2026 Feb (month)PMID41321006doi:10.1177/17407745251387571via pubmed nct search
- Lancet (London, England)2025 Feb 22PMID39919773doi:10.1016/S0140-6736(24)02808-3via clinicaltrials gov reference derived + pubmed nct search
- BMJ open2021 May 28PMID34049922doi:10.1136/bmjopen-2020-047993via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.