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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..
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Start Date
April 1, 2026
Primary Completion Date
August 1, 2026
Completion Date
September 1, 2026
Last Updated
February 24, 2026
20
ESTIMATED participants
Semaglutide Implant (NPM-139)
COMBINATION_PRODUCT
Semaglutide (Wegovy) weekly injection
DRUG
Lead Sponsor
Vivani Medical, Inc
Collaborators
NCT07225426
NCT07423780
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07430007