A Study With NLY01 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2020-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuraly, Inc.
• Treatments: Exenatide

Criteria

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