Obesity & Overweight
Conditions
Keywords
obesity, overweight, semaglutide, implant, glp-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.
Interventions
COMBINATION_PRODUCTSemaglutide 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.
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.
Sponsors
Vivani Medical, Inc
Avance Clinical Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | 4 weeks | total semaglutide concentration |
| Maximum plasma concentration (Cmax) | 4 weeks | Maximal semaglutide concentration |
| Time to maximum semaglutide concentration (Tmax) | 4 weeks | Time to reach maximal semaglutide concentration |
| Adverse Events | 4 weeks | Incidence of treatment-emergent adverse events |
Contacts
CONTACTChief Medical Officer, MD
STUDY_DIRECTORLisa Porter, MD
Vivani Medical, Inc
Outcome results
None listed