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NCT Number: NCT07430059

Safety, Tolerability and Pharmacokinetics of a Subcutaneous 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..

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC)

    Time frame: 4 weeks

    total semaglutide concentration

  2. Maximum plasma concentration (Cmax)

    Time frame: 4 weeks

    Maximal semaglutide concentration

  3. Time to maximum semaglutide concentration (Tmax)

    Time frame: 4 weeks

    Time to reach maximal semaglutide concentration

  4. Adverse Events

    Time frame: 4 weeks

    Incidence of treatment-emergent adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer, MD

CONTACT

[email protected]

4155068462

Sponsors and collaborators

Lead sponsor

Vivani Medical, Inc

Industry

Collaborators

  • Avance Clinical Pty Ltd.

Registry information

Official study title

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

Acronym: SLIM-1

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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