Clinical trial

Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

Opening soon · Phase 1 · 0 countries · Registry ID NCT07430059

Opening soonPhase 1Interventional

What this study is about

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..

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

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 Events4 weeks

Incidence of treatment-emergent adverse events

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.