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GLP-1 Receptor Agonist

NLY01 (2.5 mg) for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by Neuraly, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

Study Summary

This trial is studying a potential new treatment for early Parkinson's disease. The drug, NLY01, is a pegylated form of exenatide and is being developed as a potential treatment for neurodegenerative disorders. This trial will assess the safety, tolerability, and efficacy of NLY01 in subjects with early, untreated Parkinson's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: NLY01 (2.5 mg)Active Control1 Intervention
NLY01 2.5 mg injection
Group II: NLY01 (5.0 mg)Active Control1 Intervention
NLY01 5.0 mg injection
Group III: VehiclePlacebo Group1 Intervention
inactive drug, injection

Find a Location

Who is running the clinical trial?

Neuraly, Inc.Lead Sponsor
3 Previous Clinical Trials
236 Total Patients Enrolled
Dan LeeStudy DirectorNeuraly, Inc.
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cutoff age for inclusion in this trial below forty years old?

"This clinical trial requires participants to be between 30 and 80 years old. On the other hand, 27 studies are open for individuals younger than 18 while 481 studies focus on those over 65."

Answered by AI

How many locations are running this experiment?

"Patients have access to a broad range of medical facilities for this clinical trial, such as Booth Gardner Parkinson's Care Center in Kirkland, University of Michigan Hospital in Ann Arbor, and Massachusetts General Hospital Clinical Trials Pharmacy in Boston. Altogether there are 61 sites available nationwide."

Answered by AI

Are there any potential risks associated with the utilization of NLY01 (2.5 mg)?

"With NLY01's 2.5 mg dosage being subject to a Phase 2 trial, our team at Power estimates its safety on a scale of 1-3 as a score of 2 due to the absence of efficacy data but the presence of safety records."

Answered by AI

Is enrollment in this experiment still ongoing?

"The ongoing research is recruiting 255 adults between the ages of 30-80 who are diagnosed with Parkinson's disease using UK Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria, as well as assessments and DaTscan test results consistent with a diagnosis."

Answered by AI

Are there still open slots in this research endeavor?

"According to the available data hosted on clinicaltrials.gov, this specific medical study has ceased accepting participants at present; however, there are 484 other trials actively recruiting patients as of now. This trial was initially posted in February 2020 and last updated in November 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of California, Irvine
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What is involved and for what period of time?
PatientReceived 1 prior treatment
~50 spots leftby Apr 2025