Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

Sponsor
Vivani Medical, Inc
Study ID
NCT07430059
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Implant (NPM-139) — COMBINATION_PRODUCT
    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.
  • Semaglutide (Wegovy) weekly injection — DRUG
    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.

Study Details

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..

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Implant (NPM-139)
    Each participants in this arm will receive one Semaglutide Implant (NPM-139) which will be inserted subcutaneously in the upper outer arm and subsequently removed after 4 weeks of treatment.
  • Active Comparator: Semaglutide (Wegovy) weekly injection
    Each participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment.

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC) [ Time Frame: 4 weeks ]

Central Contacts

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