Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
ConditionObesity & Overweight
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorVivani Medical, Inc
About this trial
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..
Eligibility criteria
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- Semaglutide Implant (NPM-139)
- Semaglutide (Wegovy) weekly injection
Treatment groups
20 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Vivani Medical, Inc
Lead sponsor
Avance Clinical Pty Ltd.
Collaborator
Source ClinicalTrials.gov