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A Study With NLY01 in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04159766
Recruitment Status : Recruiting
First Posted : November 11, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Diabetes Mellitus, Type 2 Drug: NLY01 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 : October 16, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159766


Contacts
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Contact: Oliver Klein, M.D. 49 2131 4018 450 oliver.klein@profil.com

Locations
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Germany
Profil Institute fur Stoffwechselforschung GmbH Recruiting
Neuss, Germany, D-41460
Contact: Lars Barendt    49 2131 4018 258    lars.barendt@profil.com   
Profil Institute Recruiting
Neuss, Germany, D-41460
Contact: Oliver Klein, M.D.         
Sponsors and Collaborators
Neuraly, Inc.
Investigators
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Study Director: Dan Lee Neuraly, Inc.

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Responsible Party: Neuraly, Inc.
ClinicalTrials.gov Identifier: NCT04159766     History of Changes
Other Study ID Numbers: NLY01-D1
First Posted: November 11, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists