Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease (Exenatide-PD3)

April 30, 2026 updated by: University College, London

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Exenatide
Exenatide extended release 2mg (Bydureon) once weekly for 96 weeks n=100
Drug: Exenatide extended release 2mg (Bydureon)
Subcutaneous Injection
Placebo Comparator: Placebo
Exenatide extended release placebo once weekly for 96 weeks n=100
Drug: Exenatide extended release 2mg (Bydureon)
Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time Frame: 96 weeks
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.
96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.
Time Frame: 96 weeks
Questionnaire. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome.
96 weeks
Timed Walk assessment ON and OFF medication
Time Frame: 96 weeks
Assessment with research team
96 weeks
Montreal Cognitive Assessment
Time Frame: 96 weeks
Questionnaire. Maximum Score= 30. Lower scores indicative of worse outcome.
96 weeks
Unified Dyskinesia Rating Scale (UDysRS)
Time Frame: 96 weeks
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
96 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 96 weeks
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
96 weeks
Parkinson's Disease 39 item Quality of life questionnaire
Time Frame: 96 weeks
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.
96 weeks
Non-Motor Symptoms Scale (NMSS)
Time Frame: 96 weeks
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.
96 weeks
Levodopa Equivalent Dose
Time Frame: 96 weeks
Assessment with Research Team
96 weeks
3 day Hauser diary of Parkinson's Disease State
Time Frame: 96 weeks
Participant take Home questionnaire. (Time-On, Off, Non troublesome Dyskinesia, Troublesome dyskinesia, Asleep). Higher total scores indicate more severe motor signs of Parkinson's.
96 weeks
Safety and tolerability of exenatide as indicated by changes in pulse (bpm)
Time Frame: 96 weeks
Vital Signs
96 weeks
Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg)
Time Frame: 96 weeks
Vital Signs
96 weeks
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)
Time Frame: 96 weeks
Vital Signs
96 weeks
Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Haematocrit (%)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L)
Time Frame: 96 weeks
Full Blood Count
96 weeks
Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs)
Time Frame: 96 weeks
Blood Tests (Coagulation)
96 weeks
Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time)
Time Frame: 96 weeks
Blood Tests (Coagulation)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs)
Time Frame: 96 weeks
Blood Tests (Coagulation)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs)
Time Frame: 96 weeks
Blood Tests (Coagulation)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L)
Time Frame: 96 weeks
Blood Tests (Coagulation)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin)
Time Frame: 96 weeks
Blood Tests (Blood Sugar Levels / Diabetes Testing)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L)
Time Frame: 96 weeks
Biochemistry
96 weeks
Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL)
Time Frame: 96 weeks
Biochemistry (Fasting)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL)
Time Frame: 96 weeks
Biochemistry (Fasting)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L)
Time Frame: 96 weeks
Biochemistry (Fasting)
96 weeks
Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L)
Time Frame: 96 weeks
Biochemistry (Fasting)
96 weeks
Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events
Time Frame: 96 weeks
Ongoing Safety Reporting
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tom Foltynie, University College London Comprehensive Clinical Trials Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18/0320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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