A Study With NLY01 in Subjects With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type2 Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: NLY01; Drug: Placebo

• Registration Number: NCT04159766
• Lead Sponsor: Neuraly, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-16
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NLY01 (10 mg)	NLY01	-
Placebo	Placebo	-
NLY01 (2.5 mg)	NLY01	-
NLY01 (5.0 mg)	NLY01	-

Primary Outcome Measures

Name	Time	Method
Number of Incidences of Adverse Events	35 days
Change in plasma glucagon	24 hours	Change in 24 hour plasma glucagon concentrations
Number of participants with Treatment Emergent Adverse Events	35 days
Plasma glucose	24 hours	Change of fasting glucose profiles
Change in serum insulin	24 hours	Change in 24 hour serum insulin

Trial Locations

Locations (2)

Profil Institute; 🇩🇪 Neuss, Germany

Profil Institute fur Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany