DelfaGLP-1 Atlas

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CompletedPhase 2

A Study With NLY01 in Subjects With Type 2 Diabetes

A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes

Lead sponsor

Neuraly, Inc.

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

20

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 22-35

Primary endpoints

•Treatment-emergent AEs (any)•Fasting glucose, change•Serum insulin

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04159766
Org study IDNLY01-D1

Timeline

Milestones

Study start2019-10-16actual
Study first posted2019-11-12actual
Primary completion2020-12-04actual
Study completion2020-12-04actual
Last update posted2021-03-02actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female subject with type 2 diabetes for at least one year
•Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic
•Body Mass Index (BMI) 22.0 to 35.0 kg/m^2,

Exclusion criteria

•History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
•Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator
•Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)
•History of gastroparesis
•History of severe hypoglycemia in the past 6 months
•If female, pregnant or breastfeeding

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Plasma glucose

Time frame:24 hours

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change in serum insulin

Time frame:24 hours

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number of participants with Treatment Emergent Adverse Events

Time frame:35 days

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Incidences of Adverse Events

Time frame:35 days

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change in plasma glucagon

Time frame:24 hours

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.