A Study With NLY01 in Subjects With Type 2 Diabetes

• Sponsor: Neuraly, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04159766
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arms: 4
• Actual Duration (Months): 13.6
• Patients Per Site: 10
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes; Diabetes Mellitus, Type 2	Drug: NLY01; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 16, 2019
• Actual Primary Completion Date: Dec 4, 2020
• Actual Study Completion Date: Dec 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NLY01 (2.5 mg)	Drug: NLY01; NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Active Comparator: NLY01 (5.0 mg)	Drug: NLY01; NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Active Comparator: NLY01 (10 mg)	Drug: NLY01; NLY01, a PEGylated form of the anti-diabetic peptide exenatide
Placebo Comparator: Placebo	Drug: Placebo; normal saline

Outcome Measures

Primary Outcome Measures

1. Number of participants with Treatment Emergent Adverse Events [35 days]

2. Number of Incidences of Adverse Events [35 days]

3. Plasma glucose [24 hours]

   Change of fasting glucose profiles

4. Change in serum insulin [24 hours]

   Change in 24 hour serum insulin

5. Change in plasma glucagon [24 hours]

   Change in 24 hour plasma glucagon concentrations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institute fur Stoffwechselforschung GmbH	Neuss		Germany	D-41460
2	Profil Institute	Neuss		Germany	D-41460

Sponsors and Collaborators

• Neuraly, Inc.

Investigators

• Study Director: Dan Lee, Neuraly, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neuraly, Inc.
• ClinicalTrials.gov Identifier: NCT04159766
• Other Study ID Numbers: NLY01-D1
• First Posted: Nov 12, 2019
• Last Update Posted: Mar 2, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 2, 2021