Skip to main content
OpenTrials
Completed

NCT Number: NCT04159766

A Study With NLY01 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Profil Institute, Neuss, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NLY01

Drug

NLY01, a PEGylated form of the anti-diabetic peptide exenatide

Placebo

Drug

normal saline

Primary outcomes

  1. Number of participants with Treatment Emergent Adverse Events

    Time frame: 35 days

  2. Number of Incidences of Adverse Events

    Time frame: 35 days

  3. Plasma glucose

    Time frame: 24 hours

    Change of fasting glucose profiles

  4. Change in serum insulin

    Time frame: 24 hours

    Change in 24 hour serum insulin

  5. Change in plasma glucagon

    Time frame: 24 hours

    Change in 24 hour plasma glucagon concentrations

Sponsors and collaborators

Lead sponsor

Neuraly, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.