SLIM-1

Not yet recruitingPhase 1

Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

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

Lead sponsor

Vivani Medical, Inc

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-40

Primary endpoints

•AUC•Cmax•Maximum semaglutide concentration (Tmax)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07430059

Org study IDVANI-NP-002

Timeline

Milestones

Study first posted2026-02-24actual

Last update posted2026-02-24actual

Study start2026-04estimated (month precision)

Primary completion2026-08estimated (month precision)

Study completion2026-09estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Area under the plasma concentration-time curve (AUC)

Time frame:4 weeks

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum plasma concentration (Cmax)

Time frame:4 weeks

Cmax

concentration, descriptive

Primary/protocol endpoint

Time to maximum semaglutide concentration (Tmax)

Time frame:4 weeks

Tmax

descriptive

Primary/protocol endpoint

Adverse Events

Time frame:4 weeks

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.