A Phase 1 Study to Assess the Safety of NLY01 in Healthy Subjects

NCT03672604 · Completed

Last updated 2026-05-28

This clinical trial tests the safety of the experimental drug NLY01 in healthy adult volunteers.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 96 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2018-09 · est. completion 2019-07

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03672604 ↗

Description as written by the study sponsor.

This is a Phase 1, first-in-human study designed to assess the safety, tolerability, and pharmacokinetics of NLY01, a PEGylated form of exenatide, in healthy volunteers. NLY01 is being developed as a potential treatment for neurodegenerative disorders including Parkinson's disease. This study is intended to identify the appropriate dose-range for evaluation in Parkinson's disease patients.

Treatments tested

NLY01 also known as Placebo, normal saline Drug

NLY01, a PEGylated form of the anti-diabetic peptide exenatide

Main thing measured	Treatment-Related Adverse Events
Sponsor	Neuraly, Inc.
Conditions studied	Safety and Tolerability in Healthy Volunteers
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03672604 ↗