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NCT04232969: Exenatide-PD3

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

Status unknown Phase 3 Last updated 21 December 2023
What this trial tests

Phase 3 trial testing Exenatide extended release 2mg (Bydureon) in Parkinson's Disease in 194 participants. Status unknown.

Timeline
20 January 2020
Primary endpoint
24 February 2024
31 July 2024

Quick facts

Lead sponsorUniversity College, London
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment194
Start date20 January 2020
Primary completion24 February 2024
Estimated completion31 July 2024
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University College, London

Who can join

Adults 25 to 80, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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, 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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Microglia in neurodegenerative diseases: mechanism and potential therapeutic targets.
    Gao C, Jiang J, Tan Y, Chen S. · · 2023 · cited 998× · PMID 37735487 · DOI 10.1038/s41392-023-01588-0
  2. Mitochondrial dysfunction in Parkinson's disease - a key disease hallmark with therapeutic potential.
    Henrich MT, Oertel WH, Surmeier DJ, Geibl FF. · · 2023 · cited 225× · PMID 37951933 · DOI 10.1186/s13024-023-00676-7
  3. Glucagon-like peptide-1 (GLP-1) receptor agonists and neuroinflammation: Implications for neurodegenerative disease treatment.
    Kopp KO, Glotfelty EJ, Li Y, Greig NH. · · 2022 · cited 185× · PMID 36372278 · DOI 10.1016/j.phrs.2022.106550
  4. The neuroprotective effects of glucagon-like peptide 1 in Alzheimer's and Parkinson's disease: An in-depth review.
    Reich N, Hölscher C. · · 2022 · cited 142× · PMID 36117625 · DOI 10.3389/fnins.2022.970925
  5. From geroscience to precision geromedicine: Understanding and managing aging.
    Kroemer G, Maier AB, Cuervo AM, Gladyshev VN, et al · · 2025 · cited 139× · PMID 40250404 · DOI 10.1016/j.cell.2025.03.011
  6. The Pathogenesis of Parkinson's Disease: A Complex Interplay Between Astrocytes, Microglia, and T Lymphocytes?
    MacMahon Copas AN, McComish SF, Fletcher JM, Caldwell MA. · · 2021 · cited 123× · PMID 34122308 · DOI 10.3389/fneur.2021.666737
  7. Neuroinflammation represents a common theme amongst genetic and environmental risk factors for Alzheimer and Parkinson diseases.
    Boyd RJ, Avramopoulos D, Jantzie LL, McCallion AS. · · 2022 · cited 101× · PMID 36076238 · DOI 10.1186/s12974-022-02584-x
  8. Protective properties of GLP-1 and associated peptide hormones in neurodegenerative disorders.
    Hölscher C. · · 2022 · cited 92× · PMID 33900631 · DOI 10.1111/bph.15508

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Other recruiting trials for Parkinson's Disease

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