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Exenatide

Phase 1

Overweight and Obesity | Small molecule | Metabolic |Vivani Medical, Inc.|Last Updated: Sep 23, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Exenatide · 1 trial · 2 indications

Phase 1 1
NCT05670379Assessment of Safety, Tolerability and Drug Levels of Exenatide ImplantOverweight and Obesity
COMPLETED24 Analytics
PHASE1COMPLETED
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Overweight and ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve (AUC)
9 weeks

Total exenatide concentration

Maximum plasma concentration observed (Cmax)
9 weeks

Maximal exenatide concentration

Time to maximum plasma concentration observed (Tmax)
9 weeks

Time to reach maximal exenatide concentration

Adverse events
9 weeks

Incidence of treatment-emergent adverse events

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Exenatide ImplantEXPERIMENTALOne 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.
Bydureon BCise (exenatide extended release)ACTIVE_COMPARATOR2 mg subcutaneous injection every week for a duration of 9 weeks
SemaglutideACTIVE_COMPARATOR1.0 mg subcutaneous injection every week for a duration of 9 weeks

Interventions

NameTypeDescription
Exenatide ImplantCOMBINATION_PRODUCTExenatide 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)DRUGglucagon-like peptide-1 (GLP-1) receptor agonist
Semaglutide, 1.0 mg/mLDRUGglucagon-like peptide-1 (GLP-1) receptor agonist
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Australia
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Frequently asked questions about Exenatide

What is Exenatide used for?

Exenatide is being developed for the treatment of overweight and obesity. It is a small molecule metabolic therapy that is currently in Phase 1 clinical development. The drug is also being studied in the context of type 2 diabetes, as part of an implant formulation.

Who makes Exenatide?

Exenatide is being developed by Vivani Medical, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol VANI. The company is conducting clinical research on an implantable form of exenatide for metabolic conditions.

What phase is Exenatide in?

Exenatide is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial for the exenatide implant has been completed, with results pending further analysis.

What clinical trials is Exenatide in?

Exenatide has one completed Phase 1 clinical trial, identified as NCT05670379, titled 'Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant'. This trial enrolled 24 participants and was conducted in Australia, involving healthy volunteers as well as individuals with overweight, obesity, and type 2 diabetes.

Is Exenatide the same as other diabetes medications?

Exenatide is a distinct drug being developed by Vivani Medical, Inc. It is being formulated as an implant for the treatment of overweight and obesity, and it is also being studied in the context of type 2 diabetes. No alternative names for this drug have been mentioned in the available information.