A Phase 3 clinical trial evaluating semaglutide injection for subjects with Type 2 Diabetes Mellitus completed its primary phase on 2025-08-30. The study, identified as NCT06339086, aims to assess the similarities in efficacy and safety between semaglutide injection and Ozempic® when used in patients whose glycemic control is poor despite metformin treatment.

Background

Semaglutide is a medication used in the management of Type 2 Diabetes Mellitus. This trial specifically investigates semaglutide injection, comparing its profile to Ozempic®, another form of semaglutide. The study focuses on patients who have not achieved adequate glycemic control with metformin alone.

Trial design

The clinical trial, NCT06339086, is a Phase 3 study with an enrollment of 478 participants. It is designed to evaluate semaglutide injection in subjects diagnosed with Type 2 Diabetes Mellitus. Participants in the trial will receive either a dose of semaglutide injection or Ozempic® once weekly via subcutaneous injection, as an add-on to metformin treatment, for a duration of 32 weeks. Researchers intend to compare the efficacy, safety, pharmacokinetics, and immunogenicity between the semaglutide injection and Ozempic® groups.

What this means

The primary completion of this Phase 3 trial signifies a key milestone in the evaluation of semaglutide injection for patients with Type 2 Diabetes Mellitus. The study's design to compare semaglutide injection against Ozempic® as an add-on to metformin suggests an effort to understand potential similarities in their clinical profiles. Future release of results from this trial will provide important data regarding the comparative efficacy and safety of these semaglutide formulations in this patient population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06339086, titled "Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes," was recorded on 2025-08-30 on clinicaltrials.gov.