CompletedPhase 1

Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

Australia24 participantsStarted 2024-12-20

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Area under the plasma concentration-time curve (AUC)

Timeframe: 9 weeks

Maximum plasma concentration observed (Cmax)

Timeframe: 9 weeks

Time to maximum plasma concentration observed (Tmax)

Timeframe: 9 weeks

Adverse events

Timeframe: 9 weeks

Trial details

NCT IDNCT05670379

SponsorVivani Medical, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-21

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