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Exenatide once weekly versus placebo in Parkinson's disease: a randomised, double-blind, placebo-controlled trial
Open accessAbstract
Background Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has neuroprotective effects in preclinical models of Parkinson's disease. We investigated whether these effects would be apparent in a clinical trial.Methods In this single-centre, randomised, double-blind, placebo-controlled trial, patients with moderate Parkinson's disease were randomly assigned (1:1) to receive subcutaneous injections of exenatide 2 mg or placebo once weekly for 48 weeks in addition to their regular medication, followed by a 12-week washout period. Eligible patients were aged 25-75 years, had idiopathic Parkinson's disease as measured by Queen Square Brain Bank criteria, were on dopaminergic treatment with wearing-off effects, and were at Hoehn and Yahr stage 2·5 or less when on treatment. Randomisation was by web-based randomisation with a two strata block design according to disease severity. Patients and investigators were masked to treatment allocation. The primary outcome was the adjusted difference in the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (part 3) in the practically defined off-medication state at 60 weeks. All efficacy analyses were based on a modified intention-to-treat principle, which included all patients who completed any post-randomisation follow-up assessments. The study is registered at ClinicalTrials.gov (NCT01971242) and is completed.Findings Between June 18, 2014, and March 13, 2015, 62 patients were enrolled and randomly assigned, 32 to exenatide and 30 to placebo. Our primary analysis included 31 patients in the exenatide group and 29 patients in the placebo group. At 60 weeks, off-medication scores on part 3 of the MDS-UPDRS had improved by 1·0 points (95% CI -2·6 to 0·7) in the exenatide group and worsened by 2·1 points (-0·6 to 4·8) in the placebo group, an adjusted mean difference of -3·5 points (-6·7 to -0·3; p=0·0318). Injection site reactions and gastrointestinal symptoms were common adverse events in both groups. Six serious adverse events occurred in the exenatide group and two in the placebo group, although none in either group were judged to be related to the study interventions.Interpretation Exenatide had positive effects on practically defined off-medication motor scores in Parkinson's disease, which were sustained beyond the period of exposure. Whether exenatide affects the underlying disease pathophysiology or simply induces long-lasting symptomatic effects is uncertain. Exenatide represents a major new avenue for investigation in Parkinson's disease, and effects on everyday symptoms should be examined in longer-term trials.Funding Michael J Fox Foundation for Parkinson's Research.
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“Three clinical trials consistently describe a slowed decline in motor function when using the short-acting GLP-1 receptor agonists exenatide and lixisenatide in people with Parkinson's disease; 102-104”
From GLP-1 receptor agonists and next-generation incretin-based medications: metabolic, cardiovascular, and renal benefits (2026) · cites this paper as [102]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“Treatment with exenatide or lixisenatide for 1 year produced a modest but positive effect on Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III scores in people with recently diagnosed Parkinson’s disease (15, 53).”
From Antiinflammatory actions of glucagon-like peptide-1–based therapies beyond metabolic benefits (2025) · cites this paper as [15]
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“This discrepancy may reflect differences in the neuroprotective mechanisms of semaglutide and tirzepatide vs earlier GLP-1RAs, such as exenatide, liraglutide, and lixisenatide, which have demonstrated favorable clinical benefits in early-stage Parkinson disease.33,50”
From Neurodegeneration and Stroke After Semaglutide and Tirzepatide in Patients With Diabetes and Obesity (2025) · cites this paper as [50]
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“In Parkinson's disease, phase II trials have shown that GLP-1 RAs such as exenatide and lixisenatide improve motor activity compared to placebo,53,54 and liraglutide has shown improvements in non-motor symptoms, mobility, and quality of life.55”
From The expanding role of GLP-1 receptor agonists: a narrative review of current evidence and future directions (2025) · cites this paper as [53]
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“There is increasing evidence from animal studies and clinical trials to suggest that GLP-1 receptor agonists could be beneficial in the treatment of PD, and one study using a prebiotic supplement that enhanced SCFA levels showed an increase GLP-1 levels in mouse models [141–144].”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [142]
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“Multiple GLP-1 medicines, including exenatide (15), liraglutide (16), semaglutide (17, 18), and tirzepatide (19), reduce plasma CRP levels in people living with T2D and/or obesity.”
From Antiinflammatory actions of glucagon-like peptide-1–based therapies beyond metabolic benefits (2025) · cites this paper as [15]
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“Moreover, GLP-1 receptors interact with various neurotransmitter systems such as serotonin, dopamine, and glutamate, which are essential for mood regulation and may contribute to the onset of depression and other psychological disorders [82].”
From Exploring the Side Effects of GLP-1 Receptor Agonist: To Ensure Its Optimal Positioning (2025) · cites this paper as [82]
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“There is increasing evidence from animal studies and clinical trials to suggest that GLP-1 receptor agonists could be beneficial in the treatment of PD, and one study using a prebiotic supplement that enhanced SCFA levels showed an increase GLP-1 levels in mouse models [141–144].”
From The gut–brain axis in early Parkinson’s disease: from prodrome to prevention (2025) · cites this paper as [142]
Experimental — accuracy not yet measuredIn the citing paper
“exenatide, administered at the dose approved for type 2 diabetes treatment, crosses the BBB in appreciable quantities and improves the motor and cognitive function of PD patients.”
From Microbiota–gut–brain axis and its therapeutic applications in neurodegenerative diseases (2024) · cites this paper as [616]
In the citing paper
“This study provides in vivo evidence that “beta-cell rest” can at least temporarily allow insulin secretory capacity recovery, and in vitro studies examining the effect of diazoxide on diabetic human islets produced similar findings.177”
From A review of current trends with type 2 diabetes epidemiology, aetiology, pathogenesis, treatments and future perspectives (2021) · cites this paper as [176]
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“…indicate that restoration of brain insulin signaling and antidiabetic drugs may possess a disease-modifying potential in PD. Recently, a randomized, double bind, placebo-controlled trial demonstrated that motor symptoms were significantly improved in PD patients treated with exenatide [32].”
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“Different solutions to control this confounding factor have been used, such as examining only drug-naïve PD patients at very early stages [51], or assessing patients at a more advanced stage in the “practically defined OFF medication condition” [52].”
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“…control, including mitochondrial bioenergetic enhancement, autophagy induction, microglial phenotype modulation, and facilitation of pathogenic protein clearance (Gandhi and Parhizgar, 2025; Hong et al., 2024; Urkon et al., 2025), (Hong et al., 2024; Urkon et al., 2025; Athauda et al., 2017).”
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ПЛЕЙОТРОПНЫЕ ЭФФЕКТЫ АГОНИСТОВ РЕЦЕПТОРОВ ГЛЮКАГОНОПОДОБНОГО ПЕПТИДА‑1
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Abdelaziz, A. M. (2026) · Molecular Neurobiology · doi:10.1007/s12035-026-06101-6
“The failure of NLY01, a GLP-1R agonist that indirectly suppresses conversion to pathogenic astrocyte phenotypes, to meet its primary endpoint in a Phase 2 trial (NCT04154072) serves as a cautionary tale: even mechanistically rational glial-targeted strategies can fail in humans [142, 145, 154].”
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Pantazis, C. B., Sherer, T., & Riley, E. A. U. (2026) · Springer eBooks · doi:10.1007/978-3-032-31497-0_7
Safety and tolerability of intranasal insulin in Parkinson’s disease
Johnson, J. C., Kashyap, B., Gustafson, S. K., O’Brien, M., Frey, W. H., Svitak, A. L., & Hanson, L. R. (2026) · Frontiers in Neurology · doi:10.3389/fneur.2026.1875165
“Among these, glucagon-like peptide-1 (GLP-1) receptor agonists such as exenatide have demonstrated beneficial effects on motor and cognitive outcomes in PD patients (15), without evidence to support a disease-modifying effect (16).”
Parkinson’s disease—Crucial advances and on-going challenges
Söderbom, G. (2026) · International review of neurobiology · doi:10.1016/bs.irn.2026.08.019
The Dark Side of GLP-1 Receptor Agonists: Risks and Adverse Events
Nawal, C. L., Saini, H. L., Rankawat, G., & Chejara, R. S. (2026) · Journal of the Association of Physicians of India · doi:10.59556/japi.74.1655
Zhong, Q., Wu, K. W., & Eri, J. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44037-3.01001-0
Tamrakar, S., Pe, L. S., Panmanee, J., Yang, J., & Mukda, S. (2026) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2026.119946
Brucar, L. R., Miller, K. M., & Volkow, N. D. (2026) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2026.106990
“Three SPECT imaging studies investigated the effect of GLP-1RA on dopamine transporter (DAT) availability, which serve as biomarkers of dopaminergic terminals (Klausen et al., 2022b; Athauda et al., 2017; Jensen et al., 2020).”
Abdelaziz, A. M., Fawzy, M. N., & Shokr, M. M. (2026) · Molecular Neurobiology · doi:10.1007/s12035-026-06177-0
Huang, Y., Li, P.-Y., Liu, K.-W., Li, P., Chen, S.-C., Chen, J., Meyerowitz‐Katz, G., Huang, J.-Y., & Su, P. (2026) · Therapeutic Advances in Endocrinology and Metabolism · doi:10.1177/20420188261490985
Popa, E., Popa, A. E., Poroch, V., Schreiner, T. G., Slănină, A. M., Poroch, M., Hatneanu, A. M., Ungureanu, M. I., Petroaie, A. D., Bacușcă, A. I., et al. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27198738
“Earlier exenatide studies had suggested persistence of a motor benefit after washout [53], but the larger UK phase 3 trial involving 194 participants did not demonstrate benefit on primary or secondary clinical endpoints over 96 weeks [55].”
Verlaufsmodifizierende Therapien der Parkinsonkrankheit
Schäfer, N., & Weise, D. (2026) · DNP – Die Neurologie & Psychiatrie · doi:10.1007/s15202-026-6784-y
“Diese Wirkstoff-klasse zählt derzeit mit zu den vielversprechendsten Kandida-ten für eine krankheitsmodifizierende Therapie [20, 21, 22].”
Appetitzügler bei Parkinson? Zwischen Mangelernährung und GLP1-Agonisten
Ceballos-Baumann, A. (2026) · Nervenheilkunde · doi:10.1055/a-2911-3700
Future directions in Parkinson's disease pharmacotherapy
Abo‐elnour, D. E., Helal, M. M., Ahmed, B. A., Abouelmagd, M. E., Hefnawy, M. T., Alsalhi, H. K., Abdelkader, A., Al-dardery, N. M., & Alshwayyat, S. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-27702-3.00025-x
Alsharif, M., Shrebaty, O., Aloudah, M. A., Alqahtani, M., AlOubili, R. S., Ahmed, M. J., AlBani, B., & Bana, A. E. (2026) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2026.1969490 · Cited by 1
Wang, Z., Xue, S., Zhou, X., Yuan, M., & Sun, X. (2026) · Expert Review of Clinical Immunology · doi:10.1080/1744666x.2026.2747225
Xu, A., Wei, Y., Liu, E., Tong, W., Lu, A., Zhang, F., Flatt, P., Gault, V. A., Irwin, N., Hölscher, C., et al. (2026) · Biochemical Pharmacology · doi:10.1016/j.bcp.2026.118534
Cao, Y., 张建革, & Shoujiao, P. (2026) · Free Radical Biology and Medicine · doi:10.1016/j.freeradbiomed.2026.10.027
Lakshmi, S. M., Singh, V., Vanangamudi, M., Taj, T., Shahin, H., Nath, R., Dutta, G., Avvari, S. K., Sridhar, S. B., Panigrahy, U. P., et al. (2026) · European Journal of Neuroscience · doi:10.1111/ejn.70718
Cognitive enhancers in Parkinson's disease
Sultan, N. S. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-54032-5.00011-5
Repurposing existing drugs for Parkinson's disease management
Abouelmagd, M. E., Messak, M., Gadelmawla, A. F., & Kundu, M. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-54032-5.00007-3
Srivastava, N., Mehrotra, S., Biswas, S., Jain, A., & Dixit, R. K. (2026) · International Journal of Basic & Clinical Pharmacology · doi:10.18203/2319-2003.ijbcp20263801
Henriques, J. P., Henriques, M. J., Ribeiro, R. D. C. G., Cosentino, P. L. S., & Negrato, C. A. (2026) · The Egyptian Journal of Neurology Psychiatry and Neurosurgery · doi:10.1186/s41983-026-01275-1
“In Parkinson’s disease, phase 2 studies of exenatide and lixisenatide reported slower motor progression compared with placebo [11, 12], although nearly half of the participants treated with lix-isenatide experienced nausea [12].”
Sun, J., Gao, G., Wang, S., Li, S., Tang, J., Liu, H., & Tang, T.-S. (2026) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-026-02776-4
Metadata
- Authors
- Athauda, D., Maclagan, K., Skene, S. S., Bajwa-Joseph, M., Letchford, D., Chowdhury, K., Hibbert, S., Budnik, N., Zampedri, L., Dickson, J., Li, Y., Aviles-Olmos, I., Warner, T. T., Limousin, P., Lees, A. J., Greig, N. H., Tebbs, S., & Foltynie, T.
- Affiliations
- National Hospital for Neurology and Neurosurgery (GB)
- University College London (GB)
- National Institute on Aging (US)
- Corresponding author
- Foltynie, Thomas
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 390
- Issue
- 10103
- Pages
- 1664-1675
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC5831666
- OpenAlex
- W2744843428
- Cited by
- 889
- References
- 38
- Citations by year
- 2026: 114 · 2025: 136 · 2024: 114 · 2023: 73 · 2022: 85 · 2021: 93 · 2020: 98 · 2019: 77 · 2018: 77 · 2017: 20
- FWCI
- 51.34
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Open Research (University of Surrey) (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- Surrey Research Insight Open Access (The University of Surrey) (submittedVersion)
- Funders
- National Institutes of Health (Z99 AG999999)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Parkinson's Disease Mechanisms and Treatments
- Health Sciences › Medicine › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Nuclear Receptors and Signaling
- Keywords
- Parkinson's disease, exenatide, GLP-1 receptor agonists, neuroprotection, motor symptoms, off-medication state, dopaminergic therapy, neurodegeneration, adverse events, injection site reactions, gastrointestinal symptoms, drug repurposing, disease-modifying therapy
- MeSH terms
- Exenatide, Adult, Aged, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neurologic Examination, Parkinson Disease, Peptides, Venoms, Treatment Outcome
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