Phase 2 study of oral semaglutide tablet for patients with Parkinson's disease

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Semaglutide 7mg group; semaglutide 3mg once daily for 4weeks, then 7mg once daily for 32weeks Semaglutide 14mg group; semaglutide 3mg once daily for 4weeks, then 7mg once daily for 4weeks, then 14mg once daily for 28weeks placebo group; once daily for 36weeks CONDITION: D010300 Parkinson's disease PRIMARY OUTCOME: Change in clinically defined off‐state MDS‐UPDRS part 3 score at 48week SECONDARY OUTCOME: Efficacy and Safety INCLUSION CRITERIA: 1) Aged 20‐80 years at the time of informed consent 2) Diagnosed with PD by a neurologist [In terms of diagnosis, meet the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (UKPDSBB criteria) International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic criteria (MDS‐PD criteria, clinically established PD) or MDS‐early PD criteria] 3) On‐time Modified Hoehn and Yahr classification <=2.5 4) Receiving stable PD medication for 4 weeks prior to V1. For MAO‐B inhibitors, stable dose and dosage for 12 weeks prior to V1. 5) With written informed consent
Epistemonikos ID: fdc09d019c8beb1510635ba9ba0cab5f1abc352a
First added on: Aug 26, 2024