Category: Parkinson’s Disease: Clinical Trials
Objective: This study aims to assess efficacy and disease modifying effect, safety, and optimal dose of oral semaglutide tablet, glucagon-like peptide-1 receptor agonists (GLP-1RAs), for idiopathic Parkinson’s disease (PD) patients who are in Hoehn & Yahr stages 1 to 2.5 grades.
Background: PD is a common neurodegenerative disorder affecting more than 6 million people worldwide. Anti-PD treatment represented by dopaminergic agents can ameliorate the symptoms of PD patients, but no disease modifying therapy that slows or halts disease progression is currently available. Accumulating evidence suggests that GLP-1RAs may have therapeutic effect against PD, but clinical evidence have not been established yet.
Method: Ninety-nine PD patients in multiple centers will be randomly assigned into one of three groups: oral semaglutide tablet 7mg, 14 mg, or placebo. Study drugs will be administrated once-daily as an add-on to the conventional medical treatment for PD. After 36 weeks of the treatment period which include the dose titration period, participants will be treated without study drugs for 12 weeks. Efficacy outcomes will include Japanese version of Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire 39, Montreal Cognitive Assessment, Symbol Digit Modalities Test, Digid Span Test, Noise Pareidolia Test, and Dopamine transporter imaging, and will be measured at 36 and/or 48 weeks. Primary endpoint will be change of MDS-UPDRS part 3 score in the practically defined off medication state from baseline at 48 weeks between treatment allocation groups. Safety and tolerability will be also evaluated.
Results: The protocol outline was accepted by Pharmaceuticals and Medical Devices Agency. The study protocol was approved by institutional review board of Osaka University Hospital (Approval number: 229004-A). The universal trial number of this study is U1111-1271-3794. This trial is funded by Japan Agency for Medical Research and Development.
Conclusion: This study will evaluate safety, efficacy and dosage-effect of oral semaglutide tablet for PD. The trial design including the withdrawal period of study drugs will provide insight into the disease modifying effect of semaglutide, one of GLP-1RAs, against PD.
To cite this abstract in AMA style:
Y. Kimura, T. Koda, H. Kurakami, S. Sakamoto, K. Iwasaki, H. Mochizuki. Trial protocol: Randomized double blind controlled study to investigate disease modifying effect, safety and optimal dose of oral semaglutide tablet for patients with Parkinson’s disease (MOST-ABLE study) [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/trial-protocol-randomized-double-blind-controlled-study-to-investigate-disease-modifying-effect-safety-and-optimal-dose-of-oral-semaglutide-tablet-for-patients-with-parkinsons-disease-most/. Accessed June 14, 2025.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/trial-protocol-randomized-double-blind-controlled-study-to-investigate-disease-modifying-effect-safety-and-optimal-dose-of-oral-semaglutide-tablet-for-patients-with-parkinsons-disease-most/