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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Type2 Diabetes
• Intervention / Treatment: Drug: Placebo; Drug: NLY01

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, D-41460
    • Profil Institute fur Stoffwechselforschung GmbH
  • Neuss, Germany, D-41460
    • Profil Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; normal saline
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Neuraly, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2019
• Primary Completion (ACTUAL): December 4, 2020
• Study Completion (ACTUAL): December 4, 2020

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NLY01-D1

Drug and device information, study documents

• 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