Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (LIBERATE-1)

Vivani Medical

Status and phase: Completed; Phase 1

Conditions: Type2diabetes; Overweight and Obesity

Treatments: Combination Product: Exenatide Implant; Drug: Bydureon BCise (exenatide extended release); Drug: Semaglutide, 1.0 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05670379

VANI-NP-001

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Exenatide Implant

Experimental group

Description:

One Exenatide Implant that delivers approximately 52 microgram/day of exenatide will be inserted subdermally just under the skin of the upper outer arm for the 9-week treatment period.

Treatment:

Combination Product: Exenatide Implant

Bydureon BCise (exenatide extended release)

Active Comparator group

Description:

2 mg subcutaneous injection every week for a duration of 9 weeks

Treatment:

Drug: Bydureon BCise (exenatide extended release)

Semaglutide

Active Comparator group

Description:

1.0 mg subcutaneous injection every week for a duration of 9 weeks

Treatment:

Drug: Semaglutide, 1.0 mg/mL