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Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

NCT07430059 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-30

No results posted yet for this study

Summary

The study will evaluate the safety, tolerability and drug levels of a semaglutide implant placed just under the skin for a period of 4 weeks compared to 4 weekly injections of semaglutide (Wegovy) in overweight/obese participants who are otherwise healthy..

Conditions

  • Obesity & Overweight

Interventions

COMBINATION_PRODUCT

Semaglutide Implant (NPM-139)

Semaglutide Implant (NPM-139) is a drug/device combination product consisting of a subdermal titanium implant \~23 mm long and 2 mm in diameter, containing a sterile liquid formulation of semaglutide that is released from the implant at a substantially constant rate over at least 15 weeks.

DRUG

Semaglutide (Wegovy) weekly injection

Semaglutide (Wegovy) is a clear, colorless solution provided as Wegovy FlexTouch four-dose pens: 0.25 mg/0.5 mL. It is injected SC in the abdomen, thigh or upper arm once/week.

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Vivani Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Lisa Porter, MD · Vivani Medical, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-12-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430059 on ClinicalTrials.gov