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

Type 2 Diabetes Clinical Trial

— LIBERATE-1  

Official title:

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of NPM-119 (Exenatide Implant) in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05670379
• Other study ID #: NPM-119-DM-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 2024
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Vivani Medical, Inc
• Contact: Chief Medical Officer
• Phone: 4155068462
• Email: clinical[@]vivani.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 <8.5

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vivani Medical, Inc	Medpace, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC)	Total exenatide concentration	12 weeks
Primary	Maximum plasma concentration observed (Cmax)	Maximal exenatide concentration	12 weeks
Primary	Time to maximum plasma concentration observed (Tmax)	Time to reach maximal exenatide concentration	12 weeks
Primary	Adverse events	Incidence of treatment-emergent adverse events	12 weeks