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    Summary
    EudraCT Number:2019-000398-21
    Sponsor's Protocol Code Number:NLY01-D1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-08-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-000398-21
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01 when Administered as a Single Dose in Subjects with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberNLY01-D1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNeuraly, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNeuraly, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProfil Institut für Stoffwechselforschung GmbH
    B.5.2Functional name of contact pointTim Heise / Medical Monitor
    B.5.3 Address:
    B.5.3.1Street AddressHellersbergstr. 9
    B.5.3.2Town/ cityNeuss
    B.5.3.3Post code41460
    B.5.3.4CountryGermany
    B.5.4Telephone number+4921314018411
    B.5.6E-mailtim.heise@profil.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNLY01
    D.3.2Product code NLY01
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNLY01
    D.3.9.2Current sponsor codeNLY01
    D.3.9.3Other descriptive namePEGylated (Cys40) Exenatide
    D.3.9.4EV Substance CodeSUB179551
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To investigate the effect of a single subcutaneous injection of NLY01 at different dose-levels on pharmacodynamic (PD) parameters (24-hours insulin, glucagon, glucose profiles) in subjects with type 2 diabetes
    • To investigate the safety and tolerability of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes
    E.2.2Secondary objectives of the trial
    • To investigate the pharmacokinetic (PK) profile of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes
    • To investigate the effect of a single subcutaneous injection of NLY01 at different dose-levels on pharmacodynamic (PD) parameters (gastric emptying, weight, appetite) in subjects with type 2 diabetes
    • To investigate the PK/PD correlation and concentration/effect of a single subcutaneous injection of NLY01 at different dose-levels in subjects with type 2 diabetes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated informed consent obtained before any trial-related activities
    - Male or female subject with type 2 diabetes mellitus for at least one year
    - Age between 18 and 65 years, both inclusive
    - Treated with metformin for at least 3 months either alone or in combination with a second oral antidiabetic agent.
    - Willing to continue treatment with metformin at the same dose and frequency until Day 30 and (if applicable) to pause any treatment with a second oral antidiabetic agent from at least 7 days before dosing and until Day 35
    - Body Mass Index (BMI) 22.0 to 35.0 kg/m^2, inclusive
    - HbA1c at screening between 7.0% and 9.0% (inclusive) for subjects treated with metformin alone or HbA1c at screening between 6.5% and 8.5% (inclusive) for subjects treated with metformin in combination with a second oral antidiabetic Agent
    - Considered generally healthy (apart from type 2 diabetes mellitus) upon completion of medical history and screening safety assessments, as judged by the Investigator
    E.4Principal exclusion criteria
    - Known or suspected hypersensitivity to the IMP or related products
    - Known contra-indication to exenatide
    - Established CV Disease
    - History of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months
    - Treated with insulin, GLP-1 receptor agonisits or oral antidiabetic drugs (OADs) other than those specified in the inclusion criterion 4 within 3 months prior to screening
    - Any prior exposure to an exenatide-based product (Byetta® and Bydureon®)
    - Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 90 days after dosing
    - Men with pregnant partner not willing to use male contraception (condom) until 90 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints:
    • Adverse events (including nausea, vomiting, diarrhea, hypoglycemia, injection site reactions)

    PD endpoints:
    1. Plasma glucose (PG): change of fasting PG, postprandial(PP) PG, PPPG excursions, and 24-hour PG
    2. Serum insulin and plasma glucagon: change in 24-hour serum insulin and plasma glucagon concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety endpoints:
    Ongoing during the participation of a subject

    PD endpoints:
    1. fasting, postprandial, excursions, after 24 hours
    2. initially, after 24 hours
    E.5.2Secondary end point(s)
    Safety Endpoints:
    • Physical examination
    • Vital signs
    • Electrocardiogram
    • Safety laboratory parameters
    • NLY01 antibodies

    PD endpoints:
    • Body weight: change in body weight
    • Appetite: change in appetite assessed by electronic visual analog scale (eVAS)
    • Gastric emptying: paracetamol concentrations: change in maximum concentration of paracetamol (Cmax.par) and corresponding time to reach this level (Tmax.par)
    • Exploration of the time-course of the PD Response of NLY01, in terms of percentage of decrease in plasma glucose AUC versus Day -1 in comparison to the placebo group. The PD-time course will be compared to NLY01 serum levels time course

    PK endpoints:
    • Cmax: maximum NLY01 serum concentration after a single subcutaneous injection
    • tmax: time to reach maximum serum concentration after a single subcutaneous injection
    • AUCt: the area under the serum concentration time curve from injection to the last quantifiable point after a single subcutaneous injection
    • AUC0-35: the area under the serum concentration time curve from 0 to 35 days after a single subcutaneous injection
    • AUC0-168h: the area under the serum concentration time curve from 0 to 7 days after a single subcutaneous injection
    • λz: the apparent elimination rate constant
    • t1/2:·the apparent elimination half-life
    • absorption rate constant (ka)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety Endpoints:
    Ongoing during the participation of a subject

    PD endpoints:
    as detailed in section E.5.2

    PK endpoints:
    as detailed in section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The subjects will resume their usual diabetes treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-29
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