A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease
Estimated Study Start Date: December 2019
Estimated Primary Completion Date: February 2021
Estimated Study Completion Date: March 2021

Arms:
- Active Comparator: NLY01 (2.5 mg)
- Active Comparator: NLY01 (5.0 mg)
- Placebo Comparator: Vehicle