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Trial record 1 of 1 for:    NCT04154072
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A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04154072
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : September 15, 2020
Information provided by (Responsible Party):
Neuraly, Inc.

Brief Summary:

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.

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Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: NLY01 Drug: Vehicle Phase 2

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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
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04154072

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Contact: Chris Trizna 888-497-4890

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Sponsors and Collaborators
Neuraly, Inc.
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Study Director: Dan Lee Neuraly, Inc.
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Responsible Party: Neuraly, Inc. Identifier: NCT04154072    
Other Study ID Numbers: NLY01-PD-1
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases