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Parkinson's DiseasePhase 3Exenatide-PD3NCT04232969

Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease

A Phase 3 study testing Exenatide extended release 2mg (Bydureon) in people with Parkinson's Disease, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a clinical trial in patients with Parkinson's disease (PD), of a drug called exenatide, which is already licensed for the treatment of patients with type 2 diabetes. Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Exenatide extended release 2mg (Bydureon)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
1 siteUnited Kingdom
Study dates
20 Jan 2020to 31 Jul 2024
Phase
Phase 3
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 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Parkinson's disease.
  • Hoehn and Yahr stage ≤2.5 in the ON medication state.
  • Between 25 and 80 years of age.
  • On dopaminergic treatment for at least 4 weeks before enrolment.
  • Ability to self-administer, or to arrange carer administration of trial medication.
  • Documented informed consent to participate.

Who cannot join

  • Diagnosis or suspicion of other cause for Parkinsonism.
  • Patients unable to attend the clinic visits in the practically defined OFF medication state.
  • Body mass index <18.5.
  • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
  • Significant cognitive impairment defined by a score <21 on the Montreal Cognitive Assessment.
  • Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9).
Show all 22Show fewer
  • Prior intra-cerebral surgical intervention for Parkinson's disease.
  • 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).
  • Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days
  • Previous exposure to exenatide.
  • Impaired renal function with creatinine clearance <50ml/min.
  • History of pancreatitis.
  • Type 1 or Type 2 diabetes mellitus.
  • Severe gastrointestinal disease (e.g. gastroparesis)
  • Hyperlipidaemia.
  • History or family history of medullary thyroid cancer (MTC).
  • Multiple endocrine neoplasia 2 (MEN2) syndrome.
  • Hypersensitivity to any of exenatide's excipients.
  • Females that are pregnant or breast feeding.
  • 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.
  • Participants who lack the capacity to give informed consent
  • Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator's opinion compromises the potential participant's ability to participate.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London Hospital

    London

Other trials in United Kingdom

About this study

Official title: 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

This study is a clinical trial in patients with Parkinson's disease (PD), of a drug called exenatide, which is already licensed for the treatment of patients with type 2 diabetes. There have been several groups that have confirmed that exenatide has beneficial effects of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, the investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period. In order to explore this, a randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Exenatide is being undertaken (Exenatide-PD3).

Read the detailed description

This study is a clinical trial in patients with Parkinson's disease (PD), of a drug called exenatide, which is already licensed for the treatment of patients with type 2 diabetes. There have been several groups that have confirmed that exenatide has beneficial effects of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period.

Being tested
Exenatide extended release 2mg (Bydureon)
Keywords
Parkinson's Disease, Exenatide, Parkinson's research
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exenatide extended release 2mg (Bydureon)Drug

    Subcutaneous Injection

Study groups in NCT04232969
Study groupRoleWhat they receive
ExenatideActive comparatorExenatide extended release 2mg (Bydureon) once weekly for 96 weeks n=100
Receives: Drug: Exenatide extended release 2mg (Bydureon)
PlaceboPlacebo comparatorExenatide extended release placebo once weekly for 96 weeks n=100
Receives: Drug: Exenatide extended release 2mg (Bydureon)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3

    Comparison of MDS-UPDRS part 3 motor sub-score in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Min value- 0 Max Value- 108. Higher score indicative of worse outcome.

    Measured: 96 weeks

Secondary outcomes (45)

  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.

    Questionnaire. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome.

    Measured: 96 weeks

  2. Timed Walk assessment ON and OFF medication

    Assessment with research team

    Measured: 96 weeks

  3. Montreal Cognitive Assessment

    Questionnaire. Maximum Score= 30. Lower scores indicative of worse outcome.

    Measured: 96 weeks

  4. Unified Dyskinesia Rating Scale (UDysRS)

    Questionnaire. The UDysRS has four parts: I: Historical Disability (patient perceptions) of On-Dyskinesia impact (maximum 44 points); II: Historical Disability (patient perceptions) of Off-Dystonia impact (maximum 16 points); III: Objective Impairment (dyskinesia severity, anatomical distribution over seven body regions, and type (choreic or dystonic) based on four activities observed or video-recorded (28 points); IV: Objective Disability based on Part III activities (maximum 16 points). Higher scores= worse outcomes

    Measured: 96 weeks

  5. Patient Health Questionnaire-9 (PHQ-9)

    Questionnaire. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Max Score= 27. Higher Score= worse outcome

    Measured: 96 weeks

  6. Parkinson's Disease 39 item Quality of life questionnaire

    This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure. Higher score= worse outcome.

    Measured: 96 weeks

  7. Non-Motor Symptoms Scale (NMSS)

    Questionnaire. The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD. Higher score indicative of worse outcome. NMSS total score is 0 to 360.

    Measured: 96 weeks

  8. Levodopa Equivalent Dose

    Assessment with Research Team

    Measured: 96 weeks

  9. 3 day Hauser diary of Parkinson's Disease State

    Participant take Home questionnaire. (Time-On, Off, Non troublesome Dyskinesia, Troublesome dyskinesia, Asleep). Higher total scores indicate more severe motor signs of Parkinson's.

    Measured: 96 weeks

  10. Safety and tolerability of exenatide as indicated by changes in pulse (bpm)

    Vital Signs

    Measured: 96 weeks

  11. Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg)

    Vital Signs

    Measured: 96 weeks

  12. Safety 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)

    Vital Signs

    Measured: 96 weeks

  13. Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L)

    Full Blood Count

    Measured: 96 weeks

  14. Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  15. Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL)

    Full Blood Count

    Measured: 96 weeks

  16. Safety and tolerability of exenatide as indicated by changes in Haematocrit (%)

    Full Blood Count

    Measured: 96 weeks

  17. Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  18. Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  19. Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  20. Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  21. Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  22. Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L)

    Full Blood Count

    Measured: 96 weeks

  23. Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs)

    Blood Tests (Coagulation)

    Measured: 96 weeks

  24. Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time)

    Blood Tests (Coagulation)

    Measured: 96 weeks

  25. Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs)

    Blood Tests (Coagulation)

    Measured: 96 weeks

  26. Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs)

    Blood Tests (Coagulation)

    Measured: 96 weeks

  27. Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L)

    Blood Tests (Coagulation)

    Measured: 96 weeks

  28. Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin)

    Blood Tests (Blood Sugar Levels / Diabetes Testing)

    Measured: 96 weeks

  29. Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L)

    Biochemistry

    Measured: 96 weeks

  30. Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L)

    Biochemistry

    Measured: 96 weeks

  31. Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L)

    Biochemistry

    Measured: 96 weeks

  32. Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L)

    Biochemistry

    Measured: 96 weeks

  33. Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min)

    Biochemistry

    Measured: 96 weeks

  34. Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L)

    Biochemistry

    Measured: 96 weeks

  35. Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L)

    Biochemistry

    Measured: 96 weeks

  36. Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L)

    Biochemistry

    Measured: 96 weeks

  37. Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L)

    Biochemistry

    Measured: 96 weeks

  38. Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L)

    Biochemistry

    Measured: 96 weeks

  39. Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L)

    Biochemistry

    Measured: 96 weeks

  40. Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L)

    Biochemistry

    Measured: 96 weeks

  41. Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL)

    Biochemistry (Fasting)

    Measured: 96 weeks

  42. Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL)

    Biochemistry (Fasting)

    Measured: 96 weeks

  43. Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L)

    Biochemistry (Fasting)

    Measured: 96 weeks

  44. Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L)

    Biochemistry (Fasting)

    Measured: 96 weeks

  45. Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events

    Ongoing Safety Reporting

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start20 Jan 2020
  3. Primary completion24 Feb 2024
  4. Study completion31 Jul 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04232969
Sponsor's protocol ID
18/0320
Acronym
Exenatide-PD3
Status last verified
Dec 2024
First submitted
10 Jan 2020
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vijiaratnam N, Girges C, Auld G, McComish R, King A, Skene SS, Hibbert S, Wong A, Melander S, Gibson R, Matthews H, Dickson J, Carroll C, Patrick A, Inches J, Silverdale M, Blackledge B, Whiston J, Hu M, Welch J, Duncan G, Power K, Gallen S, Kerr J, Chaudhuri KR, Batzu L, Rota S, Jabbari E, Morris H, Limousin P, Greig N, Li Y, Libri V, Gandhi S, Athauda D, Chowdhury K, Foltynie T. Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson's disease in the UK: a phase 3, multicentre, double-blind, parallel-group, randomised, placebo-controlled trial. Lancet. 2025 Feb 22;405(10479):627-636. doi: 10.1016/S0140-6736(24)02808-3. Epub 2025 Feb 4.

    PubMed 39919773

  • Vijiaratnam N, Girges C, Auld G, Chau M, Maclagan K, King A, Skene S, Chowdhury K, Hibbert S, Morris H, Limousin P, Athauda D, Carroll CB, Hu MT, Silverdale M, Duncan GW, Chaudhuri R, Lo C, Del Din S, Yarnall AJ, Rochester L, Gibson R, Dickson J, Hunter R, Libri V, Foltynie T. Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson's disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The 'Exenatide-PD3' study. BMJ Open. 2021 May 28;11(5):e047993. doi: 10.1136/bmjopen-2020-047993.

    PubMed 34049922

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide extended release 2mg (Bydureon) in people with Parkinson's Disease, run by University College, London at 1 site in United Kingdom.

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 6 inclusion and 22 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (time frame: 96 weeks). 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 NCT04232969, which also lists 2 linked publications.

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 6 May 2026.

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