A Study With NLY01 in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159766
• Other study ID #: NLY01-D1
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2019
• Est. completion date: December 4, 2020

Study information

• Verified date: March 2021
• Source: Neuraly, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• NLY01
NLY01, a PEGylated form of the anti-diabetic peptide exenatide
• Placebo
normal saline

Locations

Country	Name	City	State
Germany	Profil Institute	Neuss
Germany	Profil Institute fur Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Neuraly, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment Emergent Adverse Events		35 days
Primary	Number of Incidences of Adverse Events		35 days
Primary	Plasma glucose	Change of fasting glucose profiles	24 hours
Primary	Change in serum insulin	Change in 24 hour serum insulin	24 hours
Primary	Change in plasma glucagon	Change in 24 hour plasma glucagon concentrations	24 hours