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

Sponsor
Vivani Medical, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05670379
Collaborator
Medpace, Inc. (Industry)
48
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: NPM-119 (exenatide implant)
  • Drug: Bydureon BCise (exenatide extended release)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NPM-119

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.

Combination Product: NPM-119 (exenatide implant)
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.
Active Comparator: Bydureon BCise (exenatide extended release)

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

Drug: Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist

Outcome Measures

Primary Outcome Measures

  1. Area under the plasma concentration-time curve (AUC) [12 weeks]

    Total exenatide concentration

  2. Maximum plasma concentration observed (Cmax) [12 weeks]

    Maximal exenatide concentration

  3. Time to maximum plasma concentration observed (Tmax) [12 weeks]

    Time to reach maximal exenatide concentration

  4. Adverse events [12 weeks]

    Incidence of treatment-emergent adverse events

Secondary Outcome Measures

  1. Hemoglobin A1c (HbA1c) [12 weeks]

    Measure of average glycemic control

  2. Fasting plasma glucose (FPG) [12 weeks]

    Measure of short-term glycemic control

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vivani Medical, Inc
  • Medpace, Inc.

Investigators

  • Study Director: Lisa Porter, MD, Vivani Medical, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vivani Medical, Inc
ClinicalTrials.gov Identifier:
NCT05670379
Other Study ID Numbers:
  • NPM-119-DM-001
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Exenatide

Study Results

No Results Posted as of Jan 31, 2023