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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivani Medical, Inc
• Collaborator: Medpace, Inc.
• Treatments: Exenatide

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