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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: NLY01; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona, Mayo Clinic Scottsdale
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC/University of Southern California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles, Center for Neurotherapeutics
    • Pasadena, California, United States, 91105
      • SC3 Research
    • Sacramento, California, United States, 95816
      • University of California Davis Health
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Denver, Colorado, United States, 80204
      • University of Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Movement Disorder Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorder Center
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33133
      • Visionary Investigators Network
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33613
      • University of South Florida
    • Winter Park, Florida, United States, 32159
      • Charter Research
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Decatur, Georgia, United States, 30033
      • NeuroStudies
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group Neurology Clinic
    • Springfield, Illinois, United States, 62702
      • SIU Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Clinical Trials Pharmacy
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
  • Minnesota
    • Golden Valley, Minnesota, United States, 55427
      • Struthers Parkinson's Center
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota Delaware Clinical Research Unit
  • New Jersey
    • West Long Branch, New Jersey, United States, 07764
      • Neurology Specialists of Monmouth County
  • New York
    • New York, New York, United States, 10032
      • Neurological Institute, Columbia University Medical Center
    • New York, New York, United States, 10017
      • NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC CTRC
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo, Gardner-McMaster Parkinson Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • The Movement Disorder Clinic of Oklahoma
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Kirkland, Washington, United States, 98034
      • Booth Gardner Parkinson's Care Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
• Patients with Parkinson's disease according to protocol specified scale assessments
• DaTscan consistent with diagnosis of Parkinson's Disease
• Men or women 30 to 80 years of age

Exclusion Criteria:

• Diagnosis of secondary or atypical parkinsonism
• Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
• Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
• Pregnant or planning to become pregnant
• Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with study compliance or safety in the judgment of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NLY01 (2.5 mg); NLY01 2.5 mg injection	Drug: NLY01; exenatide and polyethylene glycol (PEG)
Active Comparator: NLY01 (5.0 mg); NLY01 5.0 mg injection	Drug: NLY01; exenatide and polyethylene glycol (PEG)
Placebo Comparator: Vehicle; inactive drug, injection	Drug: Vehicle; Saline (Sodium Chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks	This is the Unified Parkinson's Disease Rating Scale assessment (MDS-UPDRS). The investigator will assess II and III components of the Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale Part II assesses motor aspects of experiences of daily living. The Unified Parkinson's Disease Rating Scale Part III assesses motor signs of Parkinson's Disease. The Unified Parkinson's Disease Rating Scale is a widely used assessment to quantify the signs and symptoms of Parkinson's Disease. Each subscale has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate and 4=severe. The scale is completed by the investigator and scores are derived from clinician and subject input to allow the assessment of symptomatic worsening and improvement.	36 weeks

Collaborators and Investigators

• Sponsor: Neuraly, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NLY01-PD-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No