Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

NCT05670379 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: VANI-NP-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity; Type2diabetes

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration-time curve (AUC)

  Total exenatide concentration

  9 weeks

• Maximum plasma concentration observed (Cmax)

  Maximal exenatide concentration

  9 weeks

• Time to maximum plasma concentration observed (Tmax)

  Time to reach maximal exenatide concentration

  9 weeks

• Adverse events

  Incidence of treatment-emergent adverse events

  9 weeks

Study Arms (3)

Exenatide Implant

EXPERIMENTAL

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.

Combination Product: Exenatide Implant

Bydureon BCise (exenatide extended release)

ACTIVE COMPARATOR

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

Drug: Bydureon BCise (exenatide extended release)

Semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide, 1.0 mg/mL

Interventions

Exenatide Implant COMBINATION_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.

Also known as: NPM115/NPM119

Exenatide Implant

Bydureon BCise (exenatide extended release) DRUG

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

Bydureon BCise (exenatide extended release)

Semaglutide, 1.0 mg/mL DRUG

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

Also known as: Wegovy, Ozempic

Semaglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivani Medical, Inc: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (1)

CMax

Adelaide, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Exenatide; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Lisa Porter, MD

  Vivani Medical, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 4, 2023
• Study Start: December 20, 2024
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)