Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant (SLIM-1)

February 17, 2026 updated by: Vivani Medical, Inc

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant

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..

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This open label, randomized, parallel-group study will evaluate participants with a body mass index (BMI) between 27 and 40 kg/m2 (inclusive). Safety, tolerability and PK data will be collected and evaluated for the 4-week treatment period. Participants will undergo a Screening Visit and those who meet eligibility will be randomized (1:1) to one of 2 study groups:

  • Group 1: Semaglutide Implant (NPM-139)
  • Group 2: Semaglutide 0.25 mg SC once weekly All participants will be domiciled for at least 48 hours following insertion of the implant (Group 1) or first dose of semaglutide 0.25 mg (Group 2).

Subsequently, participants will return to the clinic weekly until study end. At each of these visits, participants will have blood samples drawn for PK. After sample collections, site staff will administer semaglutide injections to participants in Group 2.

After 4 weeks of treatment (end of study), final PK samples will be collected and participants with implants will undergo a brief implant removal procedure under local anesthetic.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI between 27 and 40 kg/m2 (inclusive)
  • HbA1c </= 6.0% and FPG </+ 6.7 mmil/L
  • eGFR >/= 60 mL/m2
  • No significant health issues in the opinion of the Investigator that would preclude study participation, as determined by medical history and physical examination

Exclusion Criteria:

  • Type 1 or Type 2 Diabetesa
  • A clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator
  • Treatment with glucose lowering agent(s) within 3 months before Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve (AUC)
Time Frame: 4 weeks
total semaglutide concentration
4 weeks
Maximum plasma concentration (Cmax)
Time Frame: 4 weeks
Maximal semaglutide concentration
4 weeks
Time to maximum semaglutide concentration (Tmax)
Time Frame: 4 weeks
Time to reach maximal semaglutide concentration
4 weeks
Adverse Events
Time Frame: 4 weeks
Incidence of treatment-emergent adverse events
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivani Medical, Inc

Collaborators

Avance Clinical Pty Ltd.

Investigators

  • Study Director: Lisa Porter, MD, Vivani Medical, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANI-NP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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