Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Implant (NPM-139)

    Combination product

    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) weekly injection

    Drug

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Semaglutide Implant (NPM-139)Experimental treatment 1 intervention
Group B: Semaglutide (Wegovy) weekly injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the plasma concentration-time curve (AUC)

total semaglutide concentration

Time frame
4 weeks
2

Maximum plasma concentration (Cmax)

Maximal semaglutide concentration

Time frame
4 weeks
3

Time to maximum semaglutide concentration (Tmax)

Time to reach maximal semaglutide concentration

Time frame
4 weeks
4

Adverse Events

Incidence of treatment-emergent adverse events

Time frame
4 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vivani Medical, Inc

Lead sponsor

Avance Clinical Pty Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: