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
1 other identifier
interventional
20
1 country
2
Brief Summary
This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2019
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2019
CompletedFirst Submitted
Initial submission to the registry
November 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2020
CompletedMarch 2, 2021
March 1, 2021
1.1 years
November 6, 2019
March 1, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Number of participants with Treatment Emergent Adverse Events
35 days
Number of Incidences of Adverse Events
35 days
Plasma glucose
Change of fasting glucose profiles
24 hours
Change in serum insulin
Change in 24 hour serum insulin
24 hours
Change in plasma glucagon
Change in 24 hour plasma glucagon concentrations
24 hours
Study Arms (4)
NLY01 (2.5 mg)
ACTIVE COMPARATORNLY01 (5.0 mg)
ACTIVE COMPARATORNLY01 (10 mg)
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuraly, Inc.lead
Study Sites (2)
Profil Institute fur Stoffwechselforschung GmbH
Neuss, D-41460, Germany
Profil Institute
Neuss, D-41460, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dan Lee
Neuraly, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2019
First Posted
November 12, 2019
Study Start
October 16, 2019
Primary Completion
December 4, 2020
Study Completion
December 4, 2020
Last Updated
March 2, 2021
Record last verified: 2021-03