A Phase 3 clinical trial (NCT06161844) investigating semaglutide injection (HD1916) for patients with Type 2 Diabetes Mellitus reached primary completion on 2025-05-14. This study aimed to evaluate the similarity in efficacy and safety of semaglutide injection (HD1916) compared to Ozempic®.
Background
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, widely used for the treatment of Type 2 Diabetes Mellitus. Ozempic® (semaglutide injection) is an established treatment in this therapeutic area. This trial focuses on a new semaglutide injection, HD1916, and its potential similarity to the reference product.
Trial design
The Phase 3 study, NCT06161844, titled "Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus," enrolled 506 participants. The trial investigated semaglutide injection (HD1916) in patients with Type 2 Diabetes Mellitus who had poor blood glucose control after metformin treatment. The study's primary objective was to evaluate the similarity of the efficacy and safety profile of semaglutide injection (HD1916) when compared to Ozempic®.
What this means
The primary completion of this Phase 3 trial marks a significant step towards understanding the efficacy and safety profile of semaglutide injection (HD1916). The trial's focus on demonstrating similarity to Ozempic® suggests that if successful, HD1916 could offer an additional therapeutic option for patients with Type 2 Diabetes Mellitus, potentially expanding access to semaglutide-based treatments.
Source
The information for this update was sourced from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06161844, titled "Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus," indicates primary completion on 2025-05-14 on clinicaltrials.gov.