Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

NCT07430059 | Not Yet Recruiting Phase 1

• 1 other identifier: VANI-NP-002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

obesity; overweight; semaglutide; implant; glp-1

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration-time curve (AUC)

  total semaglutide concentration

  4 weeks

• Maximum plasma concentration (Cmax)

  Maximal semaglutide concentration

  4 weeks

• Time to maximum semaglutide concentration (Tmax)

  Time to reach maximal semaglutide concentration

  4 weeks

• Adverse Events

  Incidence of treatment-emergent adverse events

  4 weeks

Study Arms (2)

Semaglutide Implant (NPM-139)

EXPERIMENTAL

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 (Wegovy) weekly injection

ACTIVE COMPARATOR

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

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 Implant (NPM-139)

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.

Semaglutide (Wegovy) weekly injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivani Medical, Inc: lead
• Avance Clinical Pty Ltd.: collaborator

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Porter, MD

  Vivani Medical, Inc

  STUDY DIRECTOR

Central Study Contacts

Chief Medical Officer, MD

CONTACT

4155068462; clinical@vivanai.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share