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Clinical trial

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

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Last updated:1st Dec 2019
Identifier: NCT04154072

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

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

Category Value
Date last updated at source 2019-11-14
Study type(s) Interventional
Expected enrolment 240
Study start date 2019-12-01
Estimated primary completion date 2021-02-01

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