Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant

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.

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