Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

Vivani Medical, Inc24 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight and Obesity Type2diabetes

Interventions

Exenatide ImplantCOMBINATION_PRODUCT

Exenatide Implant 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.

Bydureon BCise (exenatide extended release)DRUG

glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide, 1.0 mg/mLDRUG

glucagon-like peptide-1 (GLP-1) receptor agonist

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 27 to 40 kg/m\^2 * Estimated glomerular filtration rate (eGFR) \>/= 90 mL/min/1.73 m\^2 * HbA1c \< 6.0% and FPG \< 6.7 mol/L Exclusion Criteria: * Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being * History of Type 1 or Type 2 Diabetes * 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

Locations (1)

CMax

Adelaide, Australia

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve (AUC)

Total exenatide concentration

Time frame: 9 weeks

Maximum plasma concentration observed (Cmax)

Maximal exenatide concentration

Time frame: 9 weeks

Time to maximum plasma concentration observed (Tmax)

Time to reach maximal exenatide concentration

Time frame: 9 weeks

Adverse events

Incidence of treatment-emergent adverse events

Time frame: 9 weeks

Data from ClinicalTrials.gov

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