Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 12:02 PM
Study NCT ID:
NCT07430059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
Sponsor:
Vivani Medical, Inc
Organization:
Study Overview
Official Title:
A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Semaglutide Implant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLIM-1
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..
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: