Obesity & OverweightPhase 1SLIM-1NCT07430059
Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
A Phase 1 study testing Semaglutide Implant (NPM-139) and Semaglutide (Wegovy) weekly injection in people with Obesity & Overweight, run by Vivani Medical, Inc.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Semaglutide Implant (NPM-139) and Semaglutide (Wegovy) weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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..
Read the 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.
- Conditions
- Obesity & Overweight
- Being tested
- Semaglutide Implant (NPM-139), Semaglutide (Wegovy) weekly injection
- Keywords
- obesity, overweight, semaglutide, implant, glp-1
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 injectionDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Semaglutide (Wegovy) weekly injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC)
total semaglutide concentration
Measured: 4 weeks
Maximum plasma concentration (Cmax)
Maximal semaglutide concentration
Measured: 4 weeks
Time to maximum semaglutide concentration (Tmax)
Time to reach maximal semaglutide concentration
Measured: 4 weeks
Adverse Events
Incidence of treatment-emergent adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivani Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Vivani Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430059
- Sponsor's protocol ID
- VANI-NP-002
- Acronym
- SLIM-1
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant
- ClinicalTrials.gov ID
- NCT07430059
- Acronym / sponsor ID
- SLIM-1 / VANI-NP-002
- Conditions
- Obesity & Overweight
- Keywords
- obesity, overweight, semaglutide, implant, glp-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vivani Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Implant (NPM-139) | Experimental | Combination Product: 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. |
| Semaglutide (Wegovy) weekly injection | Active comparator | Drug: Semaglutide (Wegovy) weekly injectionEach participant in this arm will receive Semaglutide (Wegovy) 0.25 mg subcutaneous injection weekly for 4 weeks of treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Semaglutide Implant (NPM-139) |
| Semaglutide (Wegovy) weekly injectionSemaglutide (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. | Drug | Semaglutide (Wegovy) weekly injection |
Primary outcome
Area under the plasma concentration-time curve (AUC)
Time frame: 4 weeks
total semaglutide concentration
Maximum plasma concentration (Cmax)
Time frame: 4 weeks
Maximal semaglutide concentration
Time to maximum semaglutide concentration (Tmax)
Time frame: 4 weeks
Time to reach maximal semaglutide concentration
Adverse Events
Time frame: 4 weeks
Incidence of treatment-emergent adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Porter, MD study director
Vivani Medical, Inc
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide Implant (NPM-139) and Semaglutide (Wegovy) weekly injection in people with Obesity & Overweight, run by Vivani Medical, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer, MD (4155068462, clinical@vivanai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.