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Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes (LIBERATE-1)

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NPM-119 (exenatide implant)
Bydureon BCise (exenatide extended release)
Sponsored by
Vivani Medical, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes BMI up to 40 kg/m^2 Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 HbA1c >/= 6.5 and <10.0 Treated with a stable regimen of a GLP-1receptor agonist other than exenatide-containing drugs for a minimum of 3 months Exclusion Criteria: Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II Current or past exposure to exenatide Sulfonylurea (SU) use within the prior 3 months Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide within the previous 30 days Insulin use within the previous 3 months; glucocorticoid use at a dose >20 mg/day of prednisone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NPM-119

    Bydureon BCise (exenatide extended release)

    Arm Description

    One NPM-119 implant that delivers approximately 52 microgram/day of exenatide for a duration of 3 months will be inserted subdermally just under the skin of the upper outer arm.

    2 mg subcutaneous injection every week for a duration of 3 months

    Outcomes

    Primary Outcome Measures

    Area under the plasma concentration-time curve (AUC)
    Total exenatide concentration
    Maximum plasma concentration observed (Cmax)
    Maximal exenatide concentration
    Time to maximum plasma concentration observed (Tmax)
    Time to reach maximal exenatide concentration
    Adverse events
    Incidence of treatment-emergent adverse events

    Secondary Outcome Measures

    Hemoglobin A1c (HbA1c)
    Measure of average glycemic control
    Fasting plasma glucose (FPG)
    Measure of short-term glycemic control

    Full Information

    First Posted
    December 13, 2022
    Last Updated
    April 24, 2023
    Sponsor
    Vivani Medical, Inc
    Collaborators
    Medpace, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05670379
    Brief Title
    Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes
    Acronym
    LIBERATE-1
    Official Title
    A Phase 2a, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of 3-Month Subcutaneous NPM-119 (Exenatide Implant) in Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vivani Medical, Inc
    Collaborators
    Medpace, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, tolerability and drug levels of a 3-month exenatide implant (NPM-119) for the treatment of type 2 diabetes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NPM-119
    Arm Type
    Experimental
    Arm Description
    One NPM-119 implant that delivers approximately 52 microgram/day of exenatide for a duration of 3 months will be inserted subdermally just under the skin of the upper outer arm.
    Arm Title
    Bydureon BCise (exenatide extended release)
    Arm Type
    Active Comparator
    Arm Description
    2 mg subcutaneous injection every week for a duration of 3 months
    Intervention Type
    Combination Product
    Intervention Name(s)
    NPM-119 (exenatide implant)
    Intervention Description
    NPM-119 is a drug:device combination that delivers steady levels of exenatide, a glucagon-like peptide-1(GLP-1) receptor agonist, for an extended period of time following subdermal insertion.
    Intervention Type
    Drug
    Intervention Name(s)
    Bydureon BCise (exenatide extended release)
    Intervention Description
    glucagon-like peptide-1 (GLP-1) receptor agonist
    Primary Outcome Measure Information:
    Title
    Area under the plasma concentration-time curve (AUC)
    Description
    Total exenatide concentration
    Time Frame
    12 weeks
    Title
    Maximum plasma concentration observed (Cmax)
    Description
    Maximal exenatide concentration
    Time Frame
    12 weeks
    Title
    Time to maximum plasma concentration observed (Tmax)
    Description
    Time to reach maximal exenatide concentration
    Time Frame
    12 weeks
    Title
    Adverse events
    Description
    Incidence of treatment-emergent adverse events
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Hemoglobin A1c (HbA1c)
    Description
    Measure of average glycemic control
    Time Frame
    12 weeks
    Title
    Fasting plasma glucose (FPG)
    Description
    Measure of short-term glycemic control
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 2 diabetes BMI up to 40 kg/m^2 Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 HbA1c >/= 6.5 and <10.0 Treated with a stable regimen of a GLP-1receptor agonist other than exenatide-containing drugs for a minimum of 3 months Exclusion Criteria: Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II Current or past exposure to exenatide Sulfonylurea (SU) use within the prior 3 months Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide within the previous 30 days Insulin use within the previous 3 months; glucocorticoid use at a dose >20 mg/day of prednisone
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chief Medical Officer
    Phone
    4155068462
    Email
    clinical@vivani.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa Porter, MD
    Organizational Affiliation
    Vivani Medical, Inc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes

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